Clinical trial NCT03916276: Living in Full Even With Pain Study
Official title: Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Pain
Keywords: Chronic Pain
Opioid
Heterogeneous Pain
Musculoskeletal Pain
Mindfulness Meditation
Behavioral Activation
Cognitive Therapy
Telehealth
Opioid Misuse
Mechanisms
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: The University of Queensland
name: Medical University of South Carolina
name: Rush University
First posted: 2019-04-16
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Morphine Milligram Equivalent (MME) Average Daily Dose
timeFrame: 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)
Secondary outcomes:
measure: Change in Pain Interference (Micro-level)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Affect (Micro-level)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Physical Function
timeFrame: 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)
measure: Change in Sleep Quality
timeFrame: 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)
measure: Change in Pain Interference (Macro-level)
timeFrame: 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)
measure: Change in Affect (Macro-level)
timeFrame: 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)
Other outcomes:
measure: Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism)
timeFrame: ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported
measure: Change in Non-Judgment (Cognitive Process Mechanism, Micro-level)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Pain Intensity (Mechanism, Micro-level)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Depression and Anxiety Severity (Mechanism, Macro-level)
timeFrame: 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)
measure: Change in Activity Level (Self-report Mechanism, EMA)
timeFrame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
measure: Change in Activity Level (Self-report Mechanism, Telephone Assessed)
timeFrame: 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)
measure: Change in Non-Judgment (Cognitive Process Mechanism, Macro-level)
timeFrame: 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)
measure: Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level)
timeFrame: 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)
measure: Change in Pain Intensity (Mechanism, Macro-level)
timeFrame: 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)
Locations:
city: Seattle
country: United States
facility: University of Washington, Ninth and Jefferson Building
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Queensland
name: Melissa Day, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: