Living in Full Even With Pain Study

Not Applicable

Completed

Conditions: Musculoskeletal Pain
Chronic Pain

Interventions: Behavioral: Activation Skills (AS)
Behavioral: Mindfulness Meditation (MM)
Behavioral: Cognitive Therapy (CT)

Registration Number: NCT03916276

Lead Sponsor: University of Washington

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activation Skills (AS) Condition	Activation Skills (AS)	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.
Mindfulness Meditation (MM) Condition	Mindfulness Meditation (MM)	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.
Cognitive Therapy (CT) Condition	Cognitive Therapy (CT)	Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (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 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.