Mechanisms of Psychosocial Treatments for Chronic Pain

Brief Summary

Detailed Description

The purpose of this randomized controlled trial is to evaluate the mechanisms of cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA) as treatments for individuals with chronic pain who endorse low back pain as a primary or secondary pain problem. Participants (240 individuals) will be randomly assigned to eight (8), 1.5 hour telehealth group sessions of (1) CT, (2) MM, or (3) BA. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. Follow-up macro-level assessments will be conducted at 3- and 6-months post-treatment. The study will address two aims. Primary Objective: The objective of the proposed research is to examine the mechanisms of cognitive therapy (CT), mindfulness meditation training (MM), and behavioral activation (BA) \[Aim 1; Primary\]. After ensuring that there is at least a small effect of time on early treatment changes in the three mechanism variables, researchers will determine the extent to which late-treatment improvement in primary outcome (pain interference) associated with CT, MM, and BA is predicted by early-treatment changes in cognitive content (i.e., pain catastrophizing), cognitive process (i.e., non-judgment), and/or activity level (i.e., ActiGraph "activity counts"). Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity counts are significantly associated with late treatment improvements in pain interference. Hypothesis 1b: The Shared Mechanisms Model hypothesizes that if changes in cognitive content, cognitive process, and activity levels are shared mechanisms across the three treatments, then treatment condition will have small and non-significant effects on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be similar; Shared Mechanisms Model). Hypothesis 1c: The Specific Mechanisms Model hypothesizes that if changes in content, process, and activity level are mechanisms specific to CT, MM, and BA, respectively, then treatment condition will have a significant effect on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be different, with CT having the largest effects on early treatment decreases in catastrophizing, MM having the largest effects on early treatment increases in non-judgment, and BA having the largest effects on early treatment increases in activity level). Further, later improvement in the primary outcome will be predicted by different mechanism variables as a function of treatment condition; that is, late treatment changes in pain interference will be substantially and uniquely predicted by early treatment changes in: (1) cognitive content (i.e., pain catastrophizing) in CT but not in MM or BA; (2) cognitive process (i.e., non-judgment) in MM but not in CT or BA; and (3) activity level in BA but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome (Specific Mechanisms Model). Researchers also predict that change in the mechanism variables will precede and predict change in outcome, but not vice versa. Secondary Objective: As a secondary aim, this study will also evaluate the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments \[Aim 2; Secondary\]. The Shared (Hypothesis 2a) and Specific (Hypothesis 2b) Mechanism models will also be applied to data collected via EMA and ActiGraph daily during the 4-weeks post-treatment to better understand the post-treatment mechanisms that underlie maintenance of gains and relapse. Exploratory Objective: Test the Limit, Activate, and Enhance (LAE) moderation model. Specifically, to test if (1) higher baseline levels of catastrophizing are associated with a positive response to the CT intervention, (2) lower baseline levels of activity are associated with a positive response to BA, and (3) higher baseline levels of non-judgment are associated with a positive response to MM. Primary and Secondary Endpoint: The primary endpoint researchers propose for the primary study aim (Aim 1) is the post-treatment pain interference score, operationalized as an average of pain interference ratings made on the twice-daily diaries during the first four days after treatment (i.e., Days 43-46). The endpoint for the secondary study aim (Aim 2) is the post-treatment score at 28 days follow-up, as operationalized as the average of days 67-70 of pain interference ratings on the diaries. Design and Outcomes A randomized, 3-group parallel design, 240-subject clinical trial to test the mechanisms of cognitive therapy, mindfulness meditation, and activation skills on individuals with chronic pain who endorse low back pain as a primary or secondary pain problem. Interventions and Duration Participants will be randomly assigned to eight (8) telehealth group sessions of (1) cognitive therapy (CT), (2) mindfulness meditation (MM), or (3) behavioral activation (BA). Treatment groups will meet, on average, twice per week over the Zoom videoconferencing platform. Each session will last for a duration of about 90 minutes. Proposed mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. Macro-level assessments will be conducted at pre- and post-treatment and at 3- and 6-months post-treatment. The total time involved in the study (excluding between session skills practice) is approximately 35-40 hours over an 8 to 9-month period. Sample Size and Population Researchers plan to enroll 300 participants with moderate to severe chronic pain including low back pain as a primary or secondary pain problem to achieve a sample size of 240 completers, with 80 completers in each of the treatment groups. Enrolled participants who complete the required baseline components (baseline data and demographic questions, pre-treatment extended assessment period, technology training, re-assessment of pain interference for general activities with a score of ≥3 for the past 3 months, re-assessment of pain consistency with a response of ≥50% of the time in the past 6 months, and a minimum number of EMA surveys during one week of Baseline Monitoring (Days 1-7) will be randomized to one of the three conditions.

Primary Outcomes

Secondary Outcomes

• Change in Pain Intensity (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 Mood (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 Physical Function(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Sleep Quality(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Depression Severity(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Anxiety Severity(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Medication Use(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Pain Intensity (Macro-level)(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
• Change in Mood (Macro-level)(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)