Anxiety and Mood Disorders
Conditions
Keywords
Feasibility Studies, Meditation, psychology
Brief summary
Some older Veterans with psychological distress may under-utilize mental health services due to perceived stigma of symptom-focused interventions. This study was designed to examine the feasibility of a strengths-based compassion training intervention with Veterans ages \> 55 years with anxiety or depressive symptoms. Although this study was focused on feasibility if successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.
Detailed description
Many older Veterans in VA primary care clinics experience anxiety and depressive symptoms, but only a minority of these Veterans seek care through VA mental health services. Research suggests that some older Veterans with psychological distress under-utilize mental health services due to perceived stigma of treatments focused on mental health symptoms. However, prior research with civilians, including one study of Veterans with PTSD, suggests a strengths-focused intervention that provides group training in compassion meditation may be effective in reducing negative emotions and increasing positive emotions and well-being. This project was designed to examine the feasibility of this approach with Veterans ages \> 55 years with anxiety or depression. The study was designed to guide and support development of a future larger-size, more definitive follow-up project. . If successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.
Interventions
BEHAVIORALCompassion Meditation (CM) intervention
10 weekly 90-minute sessions. Sessions 1-3 assist participants in basic mindfulness breathing practices; sessions 4-8 focus on personal analysis of factors underlying difficulties with compassion for self or others; sessions 9 and 10 review content and assist with relapse prevention. \[These were planned as in-person groups but due to the COVID-19 social distancing requirements that started after initiation of cohort 1, the investigators had to retool the intervention for telehealth delivery.\]
OTHERHealthy Aging Psychoeducation
The investigators planned to administer a 10-week psychoeducational in-person group focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. \[Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/dull/academic to be a credible attention control in a telehealth format for the target population.\]
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This non-randomized feasibility study was designed to collect pilot data to establish feasibility for a future randomized controlled trial (RCT) of manualized compassion meditation (CM) group intervention for older Veterans identified through VA Primary Care clinics as having clinically significant psychological distress. The plan was to enroll 20 to 30 participants in a 10-week CM training group (with 8-10 participants in each group). As part of establishing feasibility for a subsequent large-scale RCT, the investigators also planned to enroll up to 10 additional participants in a 10-session psychoeducational group focused on topics in healthy aging. The intent for the latter was to examine the feasibility and appropriateness of employing this as a control condition in a follow-up RCT.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* VA San Diego Healthcare System (VASDHS) patient * current mild-to-moderate anxiety or depressive symptoms as defined by scores between 5 and 14 on the Patient Health Questionnaire (PHQ-9) and or Generalized Anxiety Disorders scale (GAD-7). * stated intention to attend the 10 group sessions at the scheduled times at the VASDHS in addition to the baseline and follow-up study assessment visits, as well as to complete the outside homework assignments * provides written informed consent for participation
Exclusion criteria
* no active suicidality/homicidality in the preceding six months * untreated alcohol or substance use disorders * changes to psychiatric medications within six months prior to the baseline evaluation * medical and/or psychiatric instability interfering with current ability to engage in the group sessions and outside homework assignments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | 36 months | The proportion of consented subjects among all screened and eligible patients. |
| Initiation Rate | 4 months | The proportion of subjects who initiate the intervention among all consented subjects. |
| Completion Rate | 12 weeks | The proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention. |
| Practice Time at Home | 12 weeks | Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Connection (SCS-R) From Baseline to Post-intervention | Baseline and 14 weeks | Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness |
| Change in Positive Emotions (mDES) From Baseline to Post-intervention | Baseline and 14 weeks | 10-item positive emotions subscale of the 20-item modified Differential Emotions Scale (mDES); scores on this subscale have a potential range of 0 to 40 with higher scores reflecting more positive emotions. |
| Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- ) | 14 weeks | The investigators will also examine the mean (and SD) change scores for each inflammatory biomarker (hs-CRP, IL-6, and TNF- ), as well as the association of these changes with practice time. |
| Change in Depression and Anxiety From Baseline to Post-intervention | Baseline and 14 weeks | Brief Symptom Inventory-18 (BSI; depression, anxiety, and somatization) Global Severity Index (GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. |
| Satisfaction With Life (SWLS) From Baseline to Post-intervention | Baseline and 14 weeks | Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction |
Countries
United States
Participant flow
Pre-assignment details
25 participants enrolled (signed the ICF) and were assigned to the CM intervention, but 3 of the 25 withdrew from the study before the first intervention session. Thus 22 participants started the CM intervention (attended at least first intervention session)
Participants by arm
| Arm | Count |
|---|---|
| Compassion Meditation (CM) Intervention Group Ten 90-minute group sessions: Sessions 1-3 assist participants in basic mindfulness breathing practices; sessions 4-8 focus on personal analysis of factors underlying difficulties with compassion for self or others; sessions 9 and 10 review content and assist with relapse prevention. | 25 |
| Psychoeducational Healthy Aging Group This would have been one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/dull/academic to be a credible attention control in a telehealth form | 0 |
| Total | 25 |
Baseline characteristics
| Characteristic | Total | Compassion Meditation (CM) Intervention Group |
|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 10.6 | 69.0 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 0 |
| other Total, other adverse events | 0 / 22 | 0 / 0 |
| serious Total, serious adverse events | 0 / 22 | 0 / 0 |
Outcome results
Primary
Completion Rate
The proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.
Time frame: 12 weeks
Population: 22 people who attended at least the first intervention session
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassion Meditation (CM) Intervention Group | Completion Rate | 13 Participants |
Primary
Enrollment Rate
The proportion of consented subjects among all screened and eligible patients.
Time frame: 36 months
Population: Participants who were successfully contacted and verbally consented to formal telephone screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassion Meditation (CM) Intervention Group | Enrollment Rate | 25 Participants |
| Psychoeducational Healthy Aging Group | Enrollment Rate | 0 Participants |
Primary
Initiation Rate
The proportion of subjects who initiate the intervention among all consented subjects.
Time frame: 4 months
Population: Participants who enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassion Meditation (CM) Intervention Group | Initiation Rate | 22 Participants |
Primary
Practice Time at Home
Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure
Time frame: 12 weeks
Population: Participants with data available on minutes practiced at home
Secondary
Change in Depression and Anxiety From Baseline to Post-intervention
Brief Symptom Inventory-18 (BSI; depression, anxiety, and somatization) Global Severity Index (GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function.
Time frame: Baseline and 14 weeks
Population: Participants with pre- and post-intervention data for BSI-GSI
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassion Meditation (CM) Intervention Group | Change in Depression and Anxiety From Baseline to Post-intervention | Pre-Intervention BSI- GSI | 17.9 score on a scale | Standard Deviation 12 |
| Compassion Meditation (CM) Intervention Group | Change in Depression and Anxiety From Baseline to Post-intervention | Post-Intervention BSI-GSI | 14.9 score on a scale | Standard Deviation 10.4 |
Secondary
Change in Positive Emotions (mDES) From Baseline to Post-intervention
10-item positive emotions subscale of the 20-item modified Differential Emotions Scale (mDES); scores on this subscale have a potential range of 0 to 40 with higher scores reflecting more positive emotions.
Time frame: Baseline and 14 weeks
Population: Participants with pre- and post-intervention scores on the mDES positive emotions subscale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassion Meditation (CM) Intervention Group | Change in Positive Emotions (mDES) From Baseline to Post-intervention | Pre-Intervention mDES Positive Emotions subscale total | 21.7 score on a scale | Standard Deviation 7.8 |
| Compassion Meditation (CM) Intervention Group | Change in Positive Emotions (mDES) From Baseline to Post-intervention | Post-Intervention mDES Positive Emotions subscale total | 21.0 score on a scale | Standard Deviation 7.8 |
Secondary
Change in Social Connection (SCS-R) From Baseline to Post-intervention
Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness
Time frame: Baseline and 14 weeks
Population: Participants with pre- to post-intervention scores on the SCS-R
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassion Meditation (CM) Intervention Group | Change in Social Connection (SCS-R) From Baseline to Post-intervention | Pre-intervention SCS-R total | 74.1 score on a scale | Standard Deviation 14.5 |
| Compassion Meditation (CM) Intervention Group | Change in Social Connection (SCS-R) From Baseline to Post-intervention | Post-intervention SCS-R total | 74.8 score on a scale | Standard Deviation 17.1 |
Secondary
Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- )
The investigators will also examine the mean (and SD) change scores for each inflammatory biomarker (hs-CRP, IL-6, and TNF- ), as well as the association of these changes with practice time.
Time frame: 14 weeks
Population: The COVID-19 pandemic social distancing restrictions began during the first group of participants and thus no follow-up blood samples could be collected for this or subsequent groups. Due to absence of follow-up blood draws for the initial group and an absence of baseline and follow-up data for the remaining participants, the inflammatory biomarker outcomes could not be examined.
Secondary
Satisfaction With Life (SWLS) From Baseline to Post-intervention
Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction
Time frame: Baseline and 14 weeks
Population: Participants with pre-post scores on the SWLS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassion Meditation (CM) Intervention Group | Satisfaction With Life (SWLS) From Baseline to Post-intervention | Pre-Intervention SWLS total | 18.0 score on a scale | Standard Deviation 9.7 |
| Compassion Meditation (CM) Intervention Group | Satisfaction With Life (SWLS) From Baseline to Post-intervention | Post-Intervention SWLS total | 21.0 score on a scale | Standard Deviation 8.8 |