Chronic Pain, Musculoskeletal Pain
Conditions
Keywords
Chronic Pain, Opioid, Heterogeneous Pain, Musculoskeletal Pain, Mindfulness Meditation, Behavioral Activation, Cognitive Therapy, Telehealth, Opioid Misuse, Mechanisms
Brief summary
This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.
Detailed description
This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone. Extended Assessments During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online. Online Surveys About two weeks before treatment starts, participants begin doing brief (\ 2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day. Activity Monitor Participants wear an activity monitor 24 hours a day for the 2.5-month Monitoring Period (which spans two weeks before treatment to one month after treatment). The activity monitor is worn on the non-dominant wrist, like a wristwatch. Weekly Interviews Beginning two weeks prior to treatment, participants will be contacted weekly by a staff member to complete a telephone survey. Participants complete 10 total surveys over the course of 10 weeks, concluding about one month after treatment ends. Each survey takes approximately 10-15 minutes. Treatment Participants are randomly assigned to one of the three treatment groups. Treatment consists of eight group treatment sessions completed remotely over a videoconferencing platform. There will be, on average, two sessions per week, and each session will take up to 90 minutes. Each treatment session will take place over the internet on a computer, tablet, or smartphone using the videoconference application. Each session will be led by the same study clinician, who is a trained clinical psychologist. Participants will be required to use a video camera and audio through either a microphone or phone for each group treatment session. All three treatment interventions will involve educating participants about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing pain and its impact. The three treatments are: (1) Mindfulness Meditation, (2) Cognitive Therapy, and (3) Behavioral Activation (BA). Each treatment intervention will have home practice activities to complete between sessions. Home practice activities may include, but are not limited to, creating thought records, listening to pre-recorded guided practices, and keeping track of activities and goals. Participants also receive a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.
Interventions
BEHAVIORALCognitive Therapy (CT)
The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
BEHAVIORALMindfulness Meditation (MM)
Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.
BEHAVIORALBehavioral Activation (BA)
Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Sponsors
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
The University of Queensland
Medical University of South Carolina
Rush University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized 3-group, 90-subject clinical trial to test the mediators and moderators of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with heterogeneous chronic pain conditions who are at risk for opioid misuse.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months); 3. Use of opioid medication in the past week; 4. Daily average opioid analgesic medication use in the past week of ≥20 MMEs; 5. Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months; 6. Able to read, speak, and understand English; and 7. Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
Exclusion criteria
1. Primary pain condition is headache; 2. Severe cognitive impairment; 3. Current alcohol or substance dependence; 4. Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus); 5. Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention; 6. Significant pain from a recent surgery or injury; 7. Pain condition for which surgery has been recommended and is planned; 8. Any planned surgery, procedure, hospitalization, treatment, or event that may conflict with or otherwise influence participation in the study; 9. Currently receiving or had received other psychosocial treatments for any pain condition; 10. Current or past participation in a research study with treatment components that may overlap, conflict, or affect those in the current study; 11. Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years; 12. Psychiatric hospitalization within the past 6 months; 13. Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months; 14. Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and 15. Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) | Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference (Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Affect (Micro-level) | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Change in Physical Function | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) | Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Sleep Quality | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) | Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Pain Interference (Macro-level) | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
| Change in Affect (Macro-level) | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Jensen, Ph.D.
University of Washington
PRINCIPAL_INVESTIGATORMelissa Day, Ph.D.
The University of Queensland
Participant flow
Recruitment details
Potential participants were identified primarily via ResearchMatch.org and via coding lists derived from medical records of UW Medicine patients. Other sources of recruitment included social media, the UW Rehabilitation Medicine departmental research participant pool, posted flyers in pain and rehabilitation clinics, clinician referrals, news releases with the UW Newsroom, and a variety of national recruitment strategies.
Pre-assignment details
N=288 participants were excluded before randomization with 254 not meeting inclusion criteria, 25 unable to be contacted, and 9 declining participation.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Therapy (CT) Condition Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via weighing the evidence; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via weighing the evidence; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. | 31 |
| Mindfulness Meditation (MM) Condition Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position. | 29 |
| Behavioral Activation (BA) Condition Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. | 31 |
| Total | 91 |
Baseline characteristics
| Characteristic | Cognitive Therapy (CT) Condition | Total | Behavioral Activation (BA) Condition | Mindfulness Meditation (MM) Condition |
|---|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 12.4 | 53.3 years STANDARD_DEVIATION 11.6 | 51.9 years STANDARD_DEVIATION 12.1 | 54.4 years STANDARD_DEVIATION 11.7 |
| Baseline MME | 80.7 Morphine milligram equivalent STANDARD_DEVIATION 84.7 | 88.3 Morphine milligram equivalent STANDARD_DEVIATION 135.1 | 75.9 Morphine milligram equivalent STANDARD_DEVIATION 79 | 115.8 Morphine milligram equivalent STANDARD_DEVIATION 215.1 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black/African American | 2 participants | 10 participants | 4 participants | 4 participants |
| Race/Ethnicity, Customized Mixed races | 1 participants | 3 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Unspecified | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 28 participants | 75 participants | 24 participants | 23 participants |
| Region of Enrollment United States | 31 participants | 91 participants | 31 participants | 29 participants |
| Sex: Female, Male Female | 25 Participants | 74 Participants | 25 Participants | 24 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 | 1 / 31 |
| other Total, other adverse events | 15 / 31 | 15 / 29 | 19 / 31 |
| serious Total, serious adverse events | 2 / 31 | 0 / 29 | 4 / 31 |
Outcome results
Primary
Change in Morphine Milligram Equivalent (MME) Average Daily Dose
Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to post-treatment | 9 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 6 months post-treatment | 7 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 6 months post-treatment | 8 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 3 months post-treatment | 12 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to post-treatment | 8 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 3 months post-treatment | 9 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 6 months post-treatment | 6 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 3 months post-treatment | 5 participants |
| Cognitive Therapy (CT) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to post-treatment | 11 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 3 months post-treatment | 11 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to post-treatment | 4 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 3 months post-treatment | 4 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 6 months post-treatment | 7 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to post-treatment | 14 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 6 months post-treatment | 8 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to post-treatment | 8 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 3 months post-treatment | 11 participants |
| Mindfulness Meditation (MM) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 6 months post-treatment | 8 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 6 months post-treatment | 5 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to post-treatment | 5 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to post-treatment | 18 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Increase in dose from pre- to 3 months post-treatment | 4 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 6 months post-treatment | 14 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 3 months post-treatment | 6 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to post-treatment | 6 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | No change in dose from pre- to 3 months post-treatment | 17 participants |
| Behavioral Activation (BA) Condition | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Decrease in dose from pre- to 6 months post-treatment | 6 participants |
p-value: >0.05Chi-squared
Secondary
Change in Affect (Macro-level)
Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to post-treatment | 0.6 change score on a scale | Standard Deviation 3.3 |
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to post-treatment | -2.1 change score on a scale | Standard Deviation 3.8 |
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment | -0.3 change score on a scale | Standard Deviation 3.4 |
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment | -1.8 change score on a scale | Standard Deviation 3.3 |
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment | 0.3 change score on a scale | Standard Deviation 3.4 |
| Cognitive Therapy (CT) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment | -1.8 change score on a scale | Standard Deviation 4.2 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment | 0.3 change score on a scale | Standard Deviation 3.8 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to post-treatment | 1.8 change score on a scale | Standard Deviation 3 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment | -1.0 change score on a scale | Standard Deviation 4.2 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment | 0.7 change score on a scale | Standard Deviation 3.2 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to post-treatment | -1.5 change score on a scale | Standard Deviation 4.4 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment | 1.0 change score on a scale | Standard Deviation 3.7 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to post-treatment | -0.6 change score on a scale | Standard Deviation 2.6 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 3 months post-treatment | -1.2 change score on a scale | Standard Deviation 3.5 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 6 months post-treatment | 0.4 change score on a scale | Standard Deviation 4.6 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Negative Affect, change from pre- to 3 months post-treatment | 0.5 change score on a scale | Standard Deviation 3.2 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to post-treatment | 0.4 change score on a scale | Standard Deviation 2.3 |
| Behavioral Activation (BA) Condition | Change in Affect (Macro-level) | Positive Affect, change from pre- to 6 months post-treatment | -0.9 change score on a scale | Standard Deviation 3.3 |
p-value: >0.05ANOVA
Secondary
Change in Affect (Micro-level)
Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Affect (Micro-level) | Positive Affect, early treatment | 0.11 scores on a scale | Standard Deviation 0.68 |
| Cognitive Therapy (CT) Condition | Change in Affect (Micro-level) | Negative Affect, early treatment | -0.15 scores on a scale | Standard Deviation 0.61 |
| Cognitive Therapy (CT) Condition | Change in Affect (Micro-level) | Positive Affect, late treatment | -0.18 scores on a scale | Standard Deviation 0.66 |
| Cognitive Therapy (CT) Condition | Change in Affect (Micro-level) | Negative Affect, late treatment | 0.02 scores on a scale | Standard Deviation 0.68 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Micro-level) | Negative Affect, late treatment | 0.28 scores on a scale | Standard Deviation 0.66 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Micro-level) | Positive Affect, early treatment | 0.21 scores on a scale | Standard Deviation 0.64 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Micro-level) | Positive Affect, late treatment | 0.15 scores on a scale | Standard Deviation 0.56 |
| Mindfulness Meditation (MM) Condition | Change in Affect (Micro-level) | Negative Affect, early treatment | 0.18 scores on a scale | Standard Deviation 0.89 |
| Behavioral Activation (BA) Condition | Change in Affect (Micro-level) | Negative Affect, late treatment | -0.04 scores on a scale | Standard Deviation 0.65 |
| Behavioral Activation (BA) Condition | Change in Affect (Micro-level) | Negative Affect, early treatment | -0.01 scores on a scale | Standard Deviation 1.01 |
| Behavioral Activation (BA) Condition | Change in Affect (Micro-level) | Positive Affect, late treatment | 0.17 scores on a scale | Standard Deviation 0.64 |
| Behavioral Activation (BA) Condition | Change in Affect (Micro-level) | Positive Affect, early treatment | -0.01 scores on a scale | Standard Deviation 0.83 |
p-value: >0.05ANOVA
Secondary
Change in Pain Interference (Macro-level)
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 3 months post-treatment | -4.6 change score on a scale | Standard Deviation 5.7 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level) | Change from pre- to post-treatment | -4.8 change score on a scale | Standard Deviation 7.2 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 6 months post-treatment | -4.0 change score on a scale | Standard Deviation 6.1 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 3 months post-treatment | -2.9 change score on a scale | Standard Deviation 5.2 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level) | Change from pre- to post-treatment | -6.6 change score on a scale | Standard Deviation 5.4 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 6 months post-treatment | -3.0 change score on a scale | Standard Deviation 6.2 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level) | Change from pre- to post-treatment | -3.1 change score on a scale | Standard Deviation 5.9 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 6 months post-treatment | -1.7 change score on a scale | Standard Deviation 5.9 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Macro-level) | Change from pre- to 3 months post-treatment | -2.1 change score on a scale | Standard Deviation 5.9 |
p-value: >0.05ANOVA
Secondary
Change in Pain Interference (Micro-level)
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Micro-level) | Early treatment slope | -1.61 scores on a scale | Standard Deviation 4.78 |
| Cognitive Therapy (CT) Condition | Change in Pain Interference (Micro-level) | Late treatment slope | 0.44 scores on a scale | Standard Deviation 4.54 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Micro-level) | Early treatment slope | -0.13 scores on a scale | Standard Deviation 5.35 |
| Mindfulness Meditation (MM) Condition | Change in Pain Interference (Micro-level) | Late treatment slope | 0.81 scores on a scale | Standard Deviation 7.57 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Micro-level) | Early treatment slope | 0.23 scores on a scale | Standard Deviation 3.51 |
| Behavioral Activation (BA) Condition | Change in Pain Interference (Micro-level) | Late treatment slope | -1.38 scores on a scale | Standard Deviation 3.39 |
p-value: >0.05ANOVA
Secondary
Change in Physical Function
Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment | -0.6 change score on a scale | Standard Deviation 3.5 |
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to post-treatment | 0.4 change score on a scale | Standard Deviation 2.9 |
| Cognitive Therapy (CT) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment | 0.3 change score on a scale | Standard Deviation 4.1 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment | 1.4 change score on a scale | Standard Deviation 4.7 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to post-treatment | 1.7 change score on a scale | Standard Deviation 4.1 |
| Mindfulness Meditation (MM) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment | 3.0 change score on a scale | Standard Deviation 5.2 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to post-treatment | 1.5 change score on a scale | Standard Deviation 6.5 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to 6 months post-treatment | 2.3 change score on a scale | Standard Deviation 4.6 |
| Behavioral Activation (BA) Condition | Change in Physical Function | Change from pre- to 3 months post-treatment | 0.9 change score on a scale | Standard Deviation 3.2 |
p-value: >0.05ANOVA
Secondary
Change in Sleep Quality
Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment | -3.4 change score on a scale | Standard Deviation 6 |
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to post-treatment | -3.9 change score on a scale | Standard Deviation 8.6 |
| Cognitive Therapy (CT) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment | -3.3 change score on a scale | Standard Deviation 6.8 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment | -0.4 change score on a scale | Standard Deviation 8.8 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to post-treatment | 0.3 change score on a scale | Standard Deviation 8.1 |
| Mindfulness Meditation (MM) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment | -0.2 change score on a scale | Standard Deviation 6.3 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to post-treatment | 0.8 change score on a scale | Standard Deviation 7.8 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to 6 months post-treatment | 0.8 change score on a scale | Standard Deviation 8.5 |
| Behavioral Activation (BA) Condition | Change in Sleep Quality | Change from pre- to 3 months post-treatment | -0.8 change score on a scale | Standard Deviation 6.8 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism)
Primary Mechanism Variable Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear time from the analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score theoretically is zero, with no theoretical maximum score. Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts.
Time frame: ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Early treatment (at baseline to 2 weeks) | -107353.64 activity counts | Standard Deviation 505760.75 |
| Cognitive Therapy (CT) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Late treatment (at 2 weeks to 4 weeks) | 25400.60 activity counts | Standard Deviation 416600.39 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Early treatment (at baseline to 2 weeks) | -20966.51 activity counts | Standard Deviation 437438.18 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Late treatment (at 2 weeks to 4 weeks) | -58278.17 activity counts | Standard Deviation 431604.42 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Early treatment (at baseline to 2 weeks) | 212816.61 activity counts | Standard Deviation 644084.02 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Late treatment (at 2 weeks to 4 weeks) | 93312.68 activity counts | Standard Deviation 607646.06 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Activity Level (Self-report Mechanism, EMA)
Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The daily EMA items asked how many times that day did the participant engage in \>15mins of strenuous exercise, \>15mins of moderate exercise and \>15mins of mild exercise. The total frequencies for each category for a week were summed, and this scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Early treatment slope | 3.3 scores on a scale | Standard Deviation 25.4 |
| Cognitive Therapy (CT) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Late treatment slope | -2.1 scores on a scale | Standard Deviation 16.5 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Early treatment slope | -1.0 scores on a scale | Standard Deviation 23.2 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Late treatment slope | 6.6 scores on a scale | Standard Deviation 19.8 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Early treatment slope | -0.3 scores on a scale | Standard Deviation 20.5 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Self-report Mechanism, EMA) | Late treatment slope | 8.0 scores on a scale | Standard Deviation 21.2 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Activity Level (Self-report Mechanism, Telephone Assessed)
Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants were asked how many times in the past 7-days did they engage in \>15mins of strenuous exercise, \>15mins of moderate exercise and \>15mins of mild exercise. This scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 3 months post-treatment | 16.40 change score on a scale | Standard Deviation 151.63 |
| Cognitive Therapy (CT) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to post-treatment | 13.31 change score on a scale | Standard Deviation 41.67 |
| Cognitive Therapy (CT) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 6 months post-treatment | 0.89 change score on a scale | Standard Deviation 114.42 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 3 months post-treatment | 1.83 change score on a scale | Standard Deviation 53.54 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to post-treatment | 11.63 change score on a scale | Standard Deviation 45.34 |
| Mindfulness Meditation (MM) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 6 months post-treatment | 0.59 change score on a scale | Standard Deviation 34.73 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to post-treatment | 20.65 change score on a scale | Standard Deviation 51.77 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 6 months post-treatment | 0.05 change score on a scale | Standard Deviation 33.12 |
| Behavioral Activation (BA) Condition | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Change from pre- to 3 months post-treatment | 45.75 change score on a scale | Standard Deviation 193.01 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Depression and Anxiety Severity (Mechanism, Macro-level)
Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses were summed for a total raw score for depression and anxiety. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of depression and anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Depression | -3.25 change score on a scale | Standard Deviation 7 |
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Anxiety | -2.23 change score on a scale | Standard Deviation 7.11 |
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Depression | -2.41 change score on a scale | Standard Deviation 6.92 |
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Anxiety | -1.38 change score on a scale | Standard Deviation 8.56 |
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Depression | -2.34 change score on a scale | Standard Deviation 7.7 |
| Cognitive Therapy (CT) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Anxiety | -1.85 change score on a scale | Standard Deviation 8.42 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Anxiety | -1.41 change score on a scale | Standard Deviation 9.4 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Depression | -2.61 change score on a scale | Standard Deviation 7.83 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Anxiety | -2.20 change score on a scale | Standard Deviation 8.97 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Depression | -2.19 change score on a scale | Standard Deviation 9.38 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Anxiety | -2.14 change score on a scale | Standard Deviation 7.94 |
| Mindfulness Meditation (MM) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Depression | -2.26 change score on a scale | Standard Deviation 8.22 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Anxiety | -1.49 change score on a scale | Standard Deviation 7.21 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Depression | -1.99 change score on a scale | Standard Deviation 6.45 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Anxiety | 0.06 change score on a scale | Standard Deviation 8.92 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change in Anxiety | -0.45 change score on a scale | Standard Deviation 8.34 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to post-treatment change in Depression | -2.55 change score on a scale | Standard Deviation 6.65 |
| Behavioral Activation (BA) Condition | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change in Depression | -1.87 change score on a scale | Standard Deviation 7.44 |
p-value: <0.05ANOVA
Other Pre-specified
Change in Non-Judgment (Cognitive Process Mechanism, Macro-level)
Primary Mechanism Variable Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. The full 6-item scale will be used. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | 0.39 change score on a scale | Standard Deviation 1.01 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to post-treatment | 0.43 change score on a scale | Standard Deviation 1.14 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | 0.36 change score on a scale | Standard Deviation 0.98 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | 0.35 change score on a scale | Standard Deviation 1.34 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to post-treatment | 0.45 change score on a scale | Standard Deviation 1.19 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | 0.41 change score on a scale | Standard Deviation 1.24 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to post-treatment | 0.48 change score on a scale | Standard Deviation 1.18 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | 0.46 change score on a scale | Standard Deviation 1.2 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | 0.57 change score on a scale | Standard Deviation 1.04 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Non-Judgment (Cognitive Process Mechanism, Micro-level)
Primary Mechanism Variable Change in non-judgment will be measured with 4 items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Early treatment slope | 0.1 scores on a scale | Standard Deviation 0.6 |
| Cognitive Therapy (CT) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Late treatment slope | 0.00 scores on a scale | Standard Deviation 0.5 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Early treatment slope | 0.1 scores on a scale | Standard Deviation 0.8 |
| Mindfulness Meditation (MM) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Late treatment slope | 0.00 scores on a scale | Standard Deviation 0.7 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Early treatment slope | 0.05 scores on a scale | Standard Deviation 0.5 |
| Behavioral Activation (BA) Condition | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Late treatment slope | -0.1 scores on a scale | Standard Deviation 0.7 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level)
Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | -6.72 change score on a scale | Standard Deviation 9.32 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to post-treatment | -7.12 change score on a scale | Standard Deviation 8.45 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | -5.47 change score on a scale | Standard Deviation 10.29 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | -4.70 change score on a scale | Standard Deviation 8.76 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to post-treatment | -6.91 change score on a scale | Standard Deviation 9.85 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | -5.82 change score on a scale | Standard Deviation 9.59 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to post-treatment | -8.28 change score on a scale | Standard Deviation 8.12 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 6 months post-treatment | -6.56 change score on a scale | Standard Deviation 9.62 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Change from pre- to 3 months post-treatment | -7.97 change score on a scale | Standard Deviation 9.49 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level)
Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Early treatment slope | -2.0 scores on a scale | Standard Deviation 5.5 |
| Cognitive Therapy (CT) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Late treatment slope | -0.5 scores on a scale | Standard Deviation 6.4 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Early treatment slope | -1.3 scores on a scale | Standard Deviation 4.4 |
| Mindfulness Meditation (MM) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Late treatment slope | -0.6 scores on a scale | Standard Deviation 5.5 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Early treatment slope | -0.8 scores on a scale | Standard Deviation 4.8 |
| Behavioral Activation (BA) Condition | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Late treatment slope | -1.1 scores on a scale | Standard Deviation 4.1 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Intensity (Mechanism, Macro-level)
Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change | -0.90 change score on a scale | Standard Deviation 1.7 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to post-treatment change | -0.99 change score on a scale | Standard Deviation 1.8 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change | -0.96 change score on a scale | Standard Deviation 1.87 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change | -0.82 change score on a scale | Standard Deviation 1.89 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to post-treatment change | -1.18 change score on a scale | Standard Deviation 2.13 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change | -1.03 change score on a scale | Standard Deviation 1.99 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to post-treatment change | -1.29 change score on a scale | Standard Deviation 1.9 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 6 months post-treatment change | -1.09 change score on a scale | Standard Deviation 2.03 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Mechanism, Macro-level) | Pre- to 3 months post-treatment change | -1.40 change score on a scale | Standard Deviation 2.23 |
p-value: >0.05ANOVA
Other Pre-specified
Change in Pain Intensity (Mechanism, Micro-level)
Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Early treatment slope | -0.1 scores on a scale | Standard Deviation 1.03 |
| Cognitive Therapy (CT) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Late treatment slope | 0.2 scores on a scale | Standard Deviation 1.1 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Early treatment slope | 0.3 scores on a scale | Standard Deviation 0.8 |
| Mindfulness Meditation (MM) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Late treatment slope | 0.2 scores on a scale | Standard Deviation 1.5 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Early treatment slope | 0.2 scores on a scale | Standard Deviation 1.1 |
| Behavioral Activation (BA) Condition | Change in Pain Intensity (Mechanism, Micro-level) | Late treatment slope | -0.4 scores on a scale | Standard Deviation 1.1 |
p-value: >0.05ANOVA