Back on Track to Healthy Living Study

Study Overview
=================
Brief Summary
-----------------
Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Activation Skills (AS). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. Aim 1, Primary: Researchers will determine how much late-treatment improvement in pain interference related to the study's psychological treatments is predicted by early-treatment changes in the content of negative thoughts about pain (i.e., pain catastrophizing), thought processes (i.e., non-judgment), and/or activity level. Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity level are significantly related with late treatment improvements in pain interference. Hypothesis 1b: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms shared across the three treatments, then the actual treatment condition will have small and non-significant effects on early changes in the mechanism variables. This is known as the Shared Mechanisms Model. Hypothesis 1c: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms specific to CT, MM, and AS, 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 AS having the largest effects on early treatment increases in activity level). In addition, 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 AS; (2) cognitive process (i.e., non-judgment) in MM but not in CT or AS; and (3) activity level in AS but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome. This is known as the 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 examine 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: Researchers will 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 AS, and (3) higher baseline levels of non-judgment are associated with a positive response to MM.

Detailed Description
-----------------
The purpose of this randomized controlled trial is to evaluate the mechanisms of cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS) 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) AS. 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 activation skills treatment (AS) [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 AS 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 AS, 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 AS 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 AS; (2) cognitive process (i.e., non-judgment) in MM but not in CT or AS; and (3) activity level in AS 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 AS, 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) activation skills (AS). 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.

Official Title
-----------------
Mechanisms of Psychosocial Treatments for Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Cognitive Therapy (CT)
* Behavioral: Mindfulness Meditation (MM)
* Behavioral: Activation Skills (AS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years; Endorse having low back pain as a primary or secondary pain problem in the past 6 months; Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months); Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months; Chronic pain interference for general activities ≥3 on a 10-point scale for the past 3 months; Able to read, speak, and understand English; If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; and Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access. Exclusion Criteria: Primary pain condition is headache; Severe cognitive impairment; Current alcohol or substance dependence; 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); 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; Significant pain from a recent surgery or injury; Pain condition for which surgery has been recommended and is planned; Any planned surgery, procedure, or hospitalization that may conflict with or otherwise influence participation in the study; Currently receiving or had received other psychosocial treatments for any pain condition; Current or past participation in a research study with treatment components that may overlap those in the current study; Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years; Psychiatric hospitalization within the past 6 months; Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months; 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Therapy (CT) Condition<br>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. | Behavioral: Cognitive Therapy (CT)<br>* 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.<br>|
| Active Comparator: Mindfulness Meditation (MM) Condition<br>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. | Behavioral: Mindfulness Meditation (MM)<br>* 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.<br>|
| Active Comparator: Activation Skills (AS) Condition<br>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 Skills (AS)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference | 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 for a total raw score from 5-25. Higher scores indicate more self-reported pain interference with different activities/aspects of life. | Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity | Change in pain intensity of chronic pain in general 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. | Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Mood | Change in mood will be assessed using 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. | Assessed via EMA twice daily during 2 wks before Session (Tx) 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| 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 from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of physical function. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Sleep Quality (Actigraphy) | Change in sleep quality will be measured by an actigraphy device worn by the participant measuring activity level and sleep. | Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8 | 
| Change in Sleep Quality (PROMIS-29 Sleep Disturbance) | 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 to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of sleep disturbance. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Depression Severity | Change in depression will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of depression. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Anxiety Severity | Change in anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of anxiety. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Medication Use | Change in medication use will be assessed by asking participants to report use of antidepressant, sedative/hypnotic, anticonvulsant, NSAID, or opioid medications within the past 7 days. For NSAID and opioid medications, participants will be asked to report medication name, quantity per dose (e.g., 50 mg), and number of medication doses taken in the past week. For each antidepressant, sedative/hypnotic, or anticonvulsant medication, participants will report yes or no to having taken them in the past week. Researchers will calculate a morphine equivalent dose (MED) for opioid medications; a lower MED indicates less self-reported opioid medication use. For all other medication types, researchers will track medication counts (if medication was used or not) at each time point. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Cannabis Use | Change in cannabis use will be assessed by 3 investigator-developed items on cannabis use. Participants will be asked to report use of any cannabis or cannabis products in the past 7 days. Participants will be directed to note that the term cannabis is being used to refer to marijuana, cannabis concentrates, and cannabis-infused edibles (can also refer to products with CBD). At the Post-Treatment and Follow-up time points, participants will be asked whether they were taking any cannabis or cannabis products at the beginning of the study and for how long they had been taking those products prior to the start of the study. Researchers will track if cannabis was used or not at each time point. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Medication Use Attitudes | Change in medication use attitudes will be measured with the Survey of Pain Attitudes (SOPA) Medication Beliefs sub-scale. Responses from each item belonging to the Medication Beliefs sub-scale will be summed to form a total score ranging from 0 to 24. A higher score indicates greater belief in the appropriateness of medications for chronic pain management. | Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8 | 
| Change in Post-Traumatic Stress Disorder (PTSD) Severity | Severity will be measured with the PTSD CheckList - Civilian Version (PCL-C). Responses from each of the 17 items from the PCL-C will be summed to form a total score ranging from 17 to 85. A higher score indicates greater severity of PTSD related symptoms. | Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, mechanisms, cognitive therapy, mindfulness meditation, activation skills