Living in Full Even With Pain Study

Study Overview
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Brief Summary
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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) Activation Skills (AS). 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
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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) Activation Skills. 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.

Official Title
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Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain

Conditions
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Musculoskeletal Pain, Chronic Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months); Use of opioid medication in the past week; Daily average opioid analgesic medication use in the past week of ≥20 MMEs; Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months; Able to read, speak, and understand English; 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, hospitalization, treatment, or event 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, conflict, or affect 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized 3-group, 90-subject clinical trial to test the mediators and moderators of cognitive therapy, mindfulness meditation, and activation skills on individuals with heterogeneous chronic pain conditions who are at risk for opioid misuse.
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. | 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Morphine Milligram Equivalent (MME) average daily dose | Respondents will be 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 will be computed for each assessment point. | collected via phone up to 7 weeks before Tx 1, weekly starting two weeks before Tx 1 through four weeks after Tx 8, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Affect | 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. | Assessed via EMA twice daily during 2 weeks before Session (Tx) 1, 4-week tx 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 | 
| 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 t-score score based on normative data. 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 months after Tx 8), and at 3- and 6-months 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 Sleep Disturbance Short Form-4A) | 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 t-score score based on normative data. 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 months after Tx 8), and at 3- and 6-months 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 months after Tx 8), and at 3- and 6-months after Tx 8 | 
| Change in Post-Traumatic Stress Disorder (PTSD) Severity | Change in Post-Traumatic Stress Disorder (PTSD) 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 | 
| 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 t-score score based on normative data. Higher scores indicate more self-reported pain interference with different activities/aspects of life. | 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
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Opioid, Heterogeneous Pain, Musculoskeletal Pain, Mindfulness Meditation, Behavioral Activation, Cognitive Therapy, Telehealth, Opioid Misuse, Mechanisms