Chronic Musculoskeletal Pain, PTSD
Conditions
Keywords
chronic pain, PTSD
Brief summary
This project is responsive to Rehabilitation Research and Development's (RR&D) current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. This project aligns with the VA mandate for complementary and integrative health (CIH) care for Veterans and their families. CIH complements traditional care for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, CIH self-care management program delivered remotely that teaches techniques the Veteran/partner dyad can use to reduce pain, anxiety and stress, promote well-being and improve relationship quality. The research goal is to evaluate MR as an approach to manage chronic pain and PTSD symptoms, for potential subsequent implementation. This study will possibly provide a model for establishing remote access and sustainable implementation of CIH within VA.
Detailed description
Chronic pain is one of the most prevalent medical conditions in the Veteran population. Pain often presents with comorbid conditions, specifically post-traumatic stress disorder (PTSD). Comorbid chronic pain and PTSD significantly impact the quality of life of Veterans and their families. Multi-faceted therapies leveraging complementary and integrative health (CIH) are mandated within VA to complement clinical practice guidelines improve Veterans' quality of life and ability to function. This research will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population. This research is needed to test MR's effects in a clinically defined population as a complement to clinical services to assess for potential subsequent implementation within the Department of Veterans Affairs (VA). This proposal resubmission is responsive to Veterans' reported desire for CIH and several VA initiatives, including RR&D's current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. The VA Secretary of Health Strategic Priorities and the emerging VA Whole Health Program identify access to CIH for pain and self-care management as a priority to achieve optimal Veteran health. To be responsive to these priorities the 2016 VA State-of-the-Art Conference (SOTA) and Comprehensive Addiction Recovery Act (CARA) mandated VA's commitment to conduct rigorous research to integrate non-pharmacological and CIH approaches into care, with emphasis on pain management. This proposal is also responsive to the VA's Opioid Safety Initiative (OSI) and Pain Care Mission which prioritize the need for nonpharmacological treatment options for pain. The short-term goal of this study is to determine the effects of MR on (1) chronic pain, PTSD and related outcomes and (2) relationship outcomes for Veterans and their partners. The long-term goal is to determine the effectiveness and sustainability of using CIH self-care management programs like MR to improve outcomes for Veterans with chronic pain and PTSD, and their partners. The investigators propose a four-year mixed-methods randomized controlled trial of MR with two arms (treatment & wait-list control) in a clinical sample of Veterans with comorbid pain and PTSD, and their partners (e.g., spouse). The specific aims are to: (Aim 1) Determine MR effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and psychological (depression, stress, anxiety) symptoms, and global health (quality of life); (Aim 2) Determine MR effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among Veterans and their partners; and (Aim 3) Describe Veteran and partner perceived value of MR in a sub-sample of participants. The sample will consist of Veteran and partner dyads (N = 336) at the Ann Arbor, Puget Sound, and Tampa VA facilities. Aim 1 & 2 data collection will include self-report assessment of 4-data points over a 4-month period to evaluate physical, psychological, and social outcomes. Eight weekly reports will also be collected for the first two months of MR use to assess MR utilization, and pain and stress levels. Aim 3 data collection will include telephone interviews from a randomly selected sub-sample of MR treatment group dyads (n = 42) to examine MR user experiences and their suggestions making MR useful for Veterans and their partners.
Interventions
BEHAVIORALMission Reconnect
This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
There are no masked roles
Intervention model description
This research study will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English-speaking Veterans with chronic musculoskeletal pain. * Veteran is considered to have chronic musculoskeletal pain if he or she meeting either of two validated criteria: * (1) Having 2+ occurrences of any of targeted musculoskeletal ICD-9-CM codes likely to represent chronic pain recorded at visits separated by at least 30 days within past six months * (2) Having high impact chronic pain = 2+ occurrences of targeted musculoskeletal ICD-9-CM codes separated by at least 30 days within the past six months previous to study recruitment and two or more pain scores greater than or equal to 4 separated by at least 30 days within past six months. * For pain scores, the investigators will use the 0-10 numeric pain rating scale that is routinely collected at the VA. * The investigators will count two ICD-9-CM codes or pain scores recorded on the same day as one code/score. * Veteran is considered to have PTSD if he or she has a flag in his/her record indicating confirmed condition by the VA Compensation and Benefits program, has at least two outpatient visits in the year with the primary diagnosis being listed as PTSD (ICD-9-CM code 309.81) and/or had PTSD listed on the problem list\], Veteran must also have PTSD (defined by PTSD diagnosis-ICD-9-CM 309.81), the ability to access and use an electronic platform (e.g. Mobile device, internet, DVD) for MR delivery, with a willing partner to also participate in the study and MR program.
Exclusion criteria
* Moderate to severe traumatic brain injury (TBI) * Diagnosis or documented treatment for psychosis in previous 6 months * Currently in substance use disorder treatment * Non-English speaking * Visual, hearing, cognitive impairment that prevent participation or ability to consent * And/or lack of access to internet service * These individuals will be excluded due to medical, language, and technology access issues that would prevent safe and full study participation. * Pain and PTSD treatment will not be factored as an inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Outcomes Questionnaire (POQ) | Baseline, month 1,2,4 | 20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compassion for Self and Others Scales | Baseline, month 1,2,4 | 26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification. CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion. COS score ranges from 0 - 7, with higher scores indicating higher compassion for others. |
| Pain, Stress and Tension Likert | Baseline, Week 1 - 8, Week 16 | Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale. Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5 |
| Defense and Veterans Pain Rating Scale | Baseline, month 1,2,4 | 10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10 |
| PTSD: Posttraumatic Checklist | Baseline, month 1,2,4 | 20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes. Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80 |
| Quality of Life Short-form (SF12) | Baseline, month 1,2,4 | 12-items to assess quality of life using physical status and mental health distress. Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning |
| Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Baseline, month 1,2,4 | 19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month. Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty). The global score ranges from 0 to 21. Higher scores indicate worse sleep quality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stress: Perceived Stress Scale (PSS) | Baseline, month 1,2,4 | 10 Likert-scaled items, validated and widely used, to determine perceived stress levels. Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress. |
| Revised Dyadic Adjustment Scale (RDAS) | Baseline, month 1,2,4 | 14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion). Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. |
| MR Program Satisfaction Items | Month 4 | 11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR. |
| MR Program Utilization | Month 4 | Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body & massage practices. Measure calculated in number of minutes per week the participant performed the activity. |
| Depression: Beck Depression Inventory (BDI) | Baseline, month 1,2,4 | 21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale. Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms. |
Countries
United States
Participant flow
Pre-assignment details
Instruments may be administered to different individuals at different timepoints. We consented 196 Veterans (Vs) to the Treatment arm (Tx) & 168 Vs to the Waitlist-control arm (WC). Some Partners (Ps) withdrew & new Ps were added to the study. We consented 198 Ps to Tx, & 168 Ps to WC. We have Baseline data for 141 Vs (Tx), 136 Vs (WC), 137 Ps (Tx), & 133 Ps (WC). Satisfaction/utilization were only obtained after Tx initiation. The n's are the number of individuals activated (133 Vs, 133 Ps).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm - Veteran Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 196 |
| Treatment Arm - Partner Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 198 |
| Control Arm - Veteran Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 168 |
| Control Arm - Partner Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes. | 168 |
| Total | 730 |
Baseline characteristics
| Characteristic | Control Arm - Veteran | Control Arm - Partner | Treatment Arm - Veteran | Total | Treatment Arm - Partner |
|---|---|---|---|---|---|
| Age, Continuous | 57.28 Years STANDARD_DEVIATION 13.35 | 52.92 Years STANDARD_DEVIATION 14.57 | 55.80 Years STANDARD_DEVIATION 14.13 | 56.54 Years STANDARD_DEVIATION 13.74 | 52.20 Years STANDARD_DEVIATION 13.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 9 Participants | 13 Participants | 43 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 121 Participants | 123 Participants | 483 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 42 Participants | 38 Participants | 60 Participants | 204 Participants | 64 Participants |
| Pain Outcomes Questionnaire Activities of Daily Living | 10.07 units on a scale STANDARD_DEVIATION 10.09 | — | 11.71 units on a scale STANDARD_DEVIATION 11.24 | 10.91 units on a scale STANDARD_DEVIATION 10.7 | — |
| Pain Outcomes Questionnaire Fear | 10.89 units on a scale STANDARD_DEVIATION 4.88 | — | 11.38 units on a scale STANDARD_DEVIATION 4.95 | 11.14 units on a scale STANDARD_DEVIATION 4.91 | — |
| Pain Outcomes Questionnaire Mobility | 19.78 units on a scale STANDARD_DEVIATION 10.78 | — | 21.63 units on a scale STANDARD_DEVIATION 11.54 | 20.72 units on a scale STANDARD_DEVIATION 11.19 | — |
| Pain Outcomes Questionnaire Negative Affect | 28.61 units on a scale STANDARD_DEVIATION 11.5 | — | 31.93 units on a scale STANDARD_DEVIATION 11.59 | 30.30 units on a scale STANDARD_DEVIATION 11.64 | — |
| Pain Outcomes Questionnaire Pain | 6.07 units on a scale STANDARD_DEVIATION 1.92 | — | 6.25 units on a scale STANDARD_DEVIATION 1.91 | 6.16 units on a scale STANDARD_DEVIATION 1.91 | — |
| Pain Outcomes Questionnaire Total POQ | 93.64 units on a scale STANDARD_DEVIATION 33.08 | — | 103.50 units on a scale STANDARD_DEVIATION 37.13 | 98.66 units on a scale STANDARD_DEVIATION 35.48 | — |
| Pain Outcomes Questionnaire Vitality | 18.21 units on a scale STANDARD_DEVIATION 5.71 | — | 20.60 units on a scale STANDARD_DEVIATION 5.74 | 19.43 units on a scale STANDARD_DEVIATION 5.84 | — |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 3 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian (Chinese, Filipino, Japanese, Korean etc.) | 1 Participants | 4 Participants | 1 Participants | 11 Participants | 5 Participants |
| Race/Ethnicity, Customized Black and/or African American | 22 Participants | 21 Participants | 20 Participants | 83 Participants | 20 Participants |
| Race/Ethnicity, Customized Missing/Decline to Respond | 33 Participants | 38 Participants | 56 Participants | 190 Participants | 63 Participants |
| Race/Ethnicity, Customized Multiracial | 8 Participants | 2 Participants | 9 Participants | 22 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 1 Participants | 4 Participants | 13 Participants | 2 Participants |
| Race/Ethnicity, Customized White, Caucasian | 97 Participants | 102 Participants | 103 Participants | 406 Participants | 104 Participants |
| Sex/Gender, Customized Female | 33 Participants | 115 Participants | 40 Participants | 295 Participants | 107 Participants |
| Sex/Gender, Customized Male | 103 Participants | 17 Participants | 100 Participants | 249 Participants | 29 Participants |
| Sex/Gender, Customized No Data - Did not complete Baseline Data collection | 32 Participants | 35 Participants | 55 Participants | 183 Participants | 61 Participants |
| Sex/Gender, Customized Other | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 198 | 0 / 168 | 0 / 168 |
| other Total, other adverse events | 7 / 196 | 0 / 198 | 7 / 168 | 0 / 168 |
| serious Total, serious adverse events | 0 / 196 | 0 / 198 | 0 / 168 | 0 / 168 |
Outcome results
Primary
Pain Outcomes Questionnaire (POQ)
20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans activated in the protocol. Participants that opted out of responding were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Mobility | 21.4893 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Vitality | 20.2433 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Pain Rating | 6.2006 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Negative Affect | 30.7769 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Activities of Daily Living | 12.1675 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Fear | 11.5500 Units on a scale |
| Treatment Arm | Pain Outcomes Questionnaire (POQ) | Total POQ | 102.32 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Fear | 11.1400 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Total POQ | 94.9863 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Pain Rating | 6.1251 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Mobility | 20.2530 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Activities of Daily Living | 10.4716 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Vitality | 18.6968 Units on a scale |
| Control Arm | Pain Outcomes Questionnaire (POQ) | Negative Affect | 28.2654 Units on a scale |
Comparison: Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.0535Mixed Models Analysis
Comparison: Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.3729Mixed Models Analysis
Comparison: Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.4124Mixed Models Analysis
Comparison: Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.6442Mixed Models Analysis
Comparison: Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.1641Mixed Models Analysis
Comparison: Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.0487Mixed Models Analysis
Comparison: Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.p-value: 0.1554Mixed Models Analysis
Secondary
Compassion for Self and Others Scales
26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification. CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion. COS score ranges from 0 - 7, with higher scores indicating higher compassion for others.
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Compassion for Self and Others Scales | Overall COS | 5.5055 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Common Humanity Subdomain | 2.7811 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Self-judgment Subdomain | 2.4873 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Self-kindness Subdomain | 2.5769 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Isolation Subdomain | 2.6541 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Over-identification Subdomain | 2.7745 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | CSS, Mindfulness Subdomain | 3.0142 units on a scale |
| Treatment Arm | Compassion for Self and Others Scales | Overall CSS | 2.7177 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Self-judgment Subdomain | 3.0189 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Common Humanity Subdomain | 3.2938 units on a scale |
| Control Arm | Compassion for Self and Others Scales | Overall COS | 6.1296 units on a scale |
| Control Arm | Compassion for Self and Others Scales | Overall CSS | 3.2624 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Self-kindness Subdomain | 3.2407 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Isolation Subdomain | 3.2216 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Mindfulness Subdomain | 3.5882 units on a scale |
| Control Arm | Compassion for Self and Others Scales | CSS, Over-identification Subdomain | 3.2191 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Common Humanity Subdomain | 2.9178 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Over-identification Subdomain | 2.8186 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Mindfulness Subdomain | 3.1499 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Self-judgment Subdomain | 2.5104 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | Overall COS | 5.4667 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Self-kindness Subdomain | 2.7097 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | CSS, Isolation Subdomain | 2.6762 units on a scale |
| Control Arm - Veteran | Compassion for Self and Others Scales | Overall CSS | 2.7983 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | Overall CSS | 3.2908 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Self-judgment Subdomain | 3.0766 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Common Humanity Subdomain | 3.4125 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Isolation Subdomain | 3.2205 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Over-identification Subdomain | 3.2389 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | Overall COS | 5.9148 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Mindfulness Subdomain | 3.5835 units on a scale |
| Control Arm - Partner | Compassion for Self and Others Scales | CSS, Self-kindness Subdomain | 3.2320 units on a scale |
Comparison: Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.6679Mixed Models Analysis
Comparison: Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1607Mixed Models Analysis
Comparison: Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.126Mixed Models Analysis
Comparison: Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.3311Mixed Models Analysis
Comparison: Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.2416Mixed Models Analysis
Comparison: Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.3903Mixed Models Analysis
Comparison: Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.2131Mixed Models Analysis
Comparison: Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.113Mixed Models Analysis
Comparison: Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0358Mixed Models Analysis
Comparison: Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7027Mixed Models Analysis
Comparison: Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.2979Mixed Models Analysis
Comparison: Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.4278Mixed Models Analysis
Comparison: Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9933Mixed Models Analysis
Comparison: Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1589Mixed Models Analysis
Comparison: Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.8875Mixed Models Analysis
Comparison: Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.6859Mixed Models Analysis
Secondary
Defense and Veterans Pain Rating Scale
10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Stress | 6.0832 units on a scale |
| Treatment Arm | Defense and Veterans Pain Rating Scale | Overall Pain | 5.8062 units on a scale |
| Treatment Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Activity | 6.1319 units on a scale |
| Treatment Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Sleep | 5.9953 units on a scale |
| Treatment Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Mood | 6.1210 units on a scale |
| Control Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Mood | 5.9215 units on a scale |
| Control Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Sleep | 5.7385 units on a scale |
| Control Arm | Defense and Veterans Pain Rating Scale | Overall Pain | 5.8431 units on a scale |
| Control Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Stress | 5.8715 units on a scale |
| Control Arm | Defense and Veterans Pain Rating Scale | Pain Interference with Activity | 6.0125 units on a scale |
Comparison: Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1622Mixed Models Analysis
Comparison: Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.254Mixed Models Analysis
Comparison: Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0082Mixed Models Analysis
Comparison: Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0079Mixed Models Analysis
Comparison: Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1588Mixed Models Analysis
Secondary
Pain, Stress and Tension Likert
Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale. Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5
Time frame: Baseline, Week 1 - 8, Week 16
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Pain, Stress and Tension Likert | Pain (on 5-point Likert Scale) | 3.3904 units on a scale |
| Treatment Arm | Pain, Stress and Tension Likert | Stress (on 5-point Likert Scale) | 3.1728 units on a scale |
| Treatment Arm | Pain, Stress and Tension Likert | Tension (on 5-point Likert Scale) | 3.4061 units on a scale |
| Control Arm | Pain, Stress and Tension Likert | Pain (on 5-point Likert Scale) | 3.3230 units on a scale |
| Control Arm | Pain, Stress and Tension Likert | Stress (on 5-point Likert Scale) | 3.0601 units on a scale |
| Control Arm | Pain, Stress and Tension Likert | Tension (on 5-point Likert Scale) | 3.2474 units on a scale |
Comparison: Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1924Mixed Models Analysis
Comparison: Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1002Mixed Models Analysis
Comparison: Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7311Mixed Models Analysis
Secondary
PTSD: Posttraumatic Checklist
20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes. Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment Arm | PTSD: Posttraumatic Checklist | 43.5759 units on a scale |
| Control Arm | PTSD: Posttraumatic Checklist | 41.5687 units on a scale |
Comparison: Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.4808Mixed Models Analysis
Secondary
Quality of Life Short-form (SF12)
12-items to assess quality of life using physical status and mental health distress. Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Quality of Life Short-form (SF12) | Physical Health Domain | 24.1845 units on a scale |
| Treatment Arm | Quality of Life Short-form (SF12) | Mental Health Domain | 43.5871 units on a scale |
| Control Arm | Quality of Life Short-form (SF12) | Physical Health Domain | 24.0067 units on a scale |
| Control Arm | Quality of Life Short-form (SF12) | Mental Health Domain | 44.3803 units on a scale |
Comparison: Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9692Mixed Models Analysis
Comparison: Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0277Mixed Models Analysis
Secondary
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month. Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty). The global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Subjective sleep quality | 1.9406 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep disturbance | 1.9855 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep duration | 0.8399 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Use of sleep medication | 1.9685 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep latency | 2.0332 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Daytime dysfunction | 1.7602 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep efficiency | 0.3487 units on a scale |
| Treatment Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Global PSQI Score | 10.8145 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Global PSQI Score | 10.7561 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Subjective sleep quality | 1.8286 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep latency | 2.0296 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep duration | 1.0488 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep efficiency | 0.3552 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Sleep disturbance | 1.9507 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Use of sleep medication | 1.9055 units on a scale |
| Control Arm | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index - Daytime dysfunction | 1.6735 units on a scale |
Comparison: Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.5642Mixed Models Analysis
Comparison: Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.2438Mixed Models Analysis
Comparison: Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7317Mixed Models Analysis
Comparison: Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.6393Mixed Models Analysis
Comparison: Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1995Mixed Models Analysis
Comparison: Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.2886Mixed Models Analysis
Comparison: Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1323Mixed Models Analysis
Comparison: Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7923Mixed Models Analysis
Other Pre-specified
Depression: Beck Depression Inventory (BDI)
21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale. Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms.
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment Arm | Depression: Beck Depression Inventory (BDI) | 26.2981 units on a scale |
| Control Arm | Depression: Beck Depression Inventory (BDI) | 24.6833 units on a scale |
Comparison: Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1959Mixed Models Analysis
Other Pre-specified
MR Program Satisfaction Items
11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR.
Time frame: Month 4
Population: Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with quiet. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with the Mission Reconnect program. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting with Your Partner activities. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I would recommend Mission Reconnect to other Veterans and their partners. | 9 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with my partner. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with receiving massage from my partner. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting to Yourself activities. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to give my partner massage. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting with Quiet activities. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with the Mission Reconnect Support Materials activities. | 8 units on a scale |
| Treatment Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with myself. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with the Mission Reconnect Support Materials activities. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting to Yourself activities. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with my partner. | 7.5 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with myself. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I would recommend Mission Reconnect to other Veterans and their partners. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting with Quiet activities. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to connect with quiet. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with the Connecting with Your Partner activities. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with receiving massage from my partner. | 9 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with my ability to give my partner massage. | 8 units on a scale |
| Control Arm | MR Program Satisfaction Items | Response to I am satisfied with the Mission Reconnect program. | 8 units on a scale |
Other Pre-specified
MR Program Utilization
Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body & massage practices. Measure calculated in number of minutes per week the participant performed the activity.
Time frame: Month 4
Population: Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm | MR Program Utilization | Utilization in the Connecting with Yourself Domain | 30 minutes per week |
| Treatment Arm | MR Program Utilization | Utilization in the Connecting with the Quiet Domain | 40 minutes per week |
| Treatment Arm | MR Program Utilization | Utilization in the Connecting with your Partner Domain | 60 minutes per week |
| Treatment Arm | MR Program Utilization | Total Utilization | 201 minutes per week |
| Control Arm | MR Program Utilization | Total Utilization | 190 minutes per week |
| Control Arm | MR Program Utilization | Utilization in the Connecting with Yourself Domain | 55 minutes per week |
| Control Arm | MR Program Utilization | Utilization in the Connecting with your Partner Domain | 43 minutes per week |
| Control Arm | MR Program Utilization | Utilization in the Connecting with the Quiet Domain | 42 minutes per week |
Other Pre-specified
Revised Dyadic Adjustment Scale (RDAS)
14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion). Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress.
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Activities. Cohesion Domain, RDAS | 4.1842 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Values. Consensus Domain, RDAS | 7.4926 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Cohesion Domain, RDAS | 10.7219 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Affection. Consensus Domain, RDAS | 6.3686 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Conflict. Satisfaction Domain, RDAS | 6.5146 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Total RDAS | 46.5186 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Stability. Satisfaction Domain, RDAS | 8.1158 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Consensus Domain, RDAS | 21.2171 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Satisfaction Domain, RDAS | 14.6541 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Decision Making. Consensus Domain, RDAS | 7.4194 units on a scale |
| Treatment Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Discussion. Cohesion Domain, RDAS | 6.5337 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Decision Making. Consensus Domain, RDAS | 7.5229 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Values. Consensus Domain, RDAS | 7.3515 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Affection. Consensus Domain, RDAS | 6.7036 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Activities. Cohesion Domain, RDAS | 4.6511 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Discussion. Cohesion Domain, RDAS | 6.8995 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Conflict. Satisfaction Domain, RDAS | 6.5229 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Cohesion Domain, RDAS | 11.5612 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Total RDAS | 47.8727 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Consensus Domain, RDAS | 21.5715 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Stability. Satisfaction Domain, RDAS | 8.1900 units on a scale |
| Control Arm | Revised Dyadic Adjustment Scale (RDAS) | Total Satisfaction Domain, RDAS | 14.7285 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Total Satisfaction Domain, RDAS | 14.8108 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Total Cohesion Domain, RDAS | 11.5357 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Activities. Cohesion Domain, RDAS | 4.6317 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Discussion. Cohesion Domain, RDAS | 6.9106 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Total RDAS | 48.4518 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Decision Making. Consensus Domain, RDAS | 7.6760 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Values. Consensus Domain, RDAS | 7.3577 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Affection. Consensus Domain, RDAS | 7.0612 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Total Consensus Domain, RDAS | 22.0963 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Stability. Satisfaction Domain, RDAS | 8.3706 units on a scale |
| Control Arm - Veteran | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Conflict. Satisfaction Domain, RDAS | 6.4356 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Total Consensus Domain, RDAS | 22.5988 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Decision Making. Consensus Domain, RDAS | 7.7975 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Total RDAS | 48.4138 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Total Satisfaction Domain, RDAS | 14.6276 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Total Cohesion Domain, RDAS | 11.2067 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Discussion. Cohesion Domain, RDAS | 6.5975 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Stability. Satisfaction Domain, RDAS | 8.2289 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Values. Consensus Domain, RDAS | 7.5449 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Conflict. Satisfaction Domain, RDAS | 6.3987 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Affection. Consensus Domain, RDAS | 7.2958 units on a scale |
| Control Arm - Partner | Revised Dyadic Adjustment Scale (RDAS) | Subdomain: Activities. Cohesion Domain, RDAS | 4.6058 units on a scale |
Comparison: Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.8991Mixed Models Analysis
Comparison: Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.3711Mixed Models Analysis
Comparison: Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.428Mixed Models Analysis
Comparison: Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9831Mixed Models Analysis
Comparison: Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.632Mixed Models Analysis
Comparison: Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9755Mixed Models Analysis
Comparison: Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7584Mixed Models Analysis
Comparison: Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9313Mixed Models Analysis
Comparison: Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.5401Mixed Models Analysis
Comparison: Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.9421Mixed Models Analysis
Comparison: Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7042Mixed Models Analysis
Comparison: Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0114Mixed Models Analysis
Comparison: Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1358Mixed Models Analysis
Comparison: Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.4354Mixed Models Analysis
Comparison: Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.007Mixed Models Analysis
Comparison: Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0217Mixed Models Analysis
Comparison: Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.7881Mixed Models Analysis
Comparison: Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.001Mixed Models Analysis
Comparison: Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.0693Mixed Models Analysis
Comparison: Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1184Mixed Models Analysis
Comparison: Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1301Mixed Models Analysis
Comparison: Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1049Mixed Models Analysis
Other Pre-specified
Stress: Perceived Stress Scale (PSS)
10 Likert-scaled items, validated and widely used, to determine perceived stress levels. Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress.
Time frame: Baseline, month 1,2,4
Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment Arm | Stress: Perceived Stress Scale (PSS) | 22.9251 units on a scale |
| Control Arm | Stress: Perceived Stress Scale (PSS) | 21.9134 units on a scale |
Comparison: Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.p-value: 0.1792Mixed Models Analysis