N/A
N=91
Living in Full Even With Pain Study
Musculoskeletal Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03916276 ↗Enrolled (actual)
91
Serious AEs
6.6%
Results posted
Mar 2025
Primary outcome: Primary: Change in Morphine Milligram Equivalent (MME) Average Daily Dose — 8; 4; 5; 5 participants — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Therapy (CT) (Behavioral); Mindfulness Meditation (MM) (Behavioral); Behavioral Activation (BA) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Morphine Milligram Equivalent (MME) Average Daily Dose |
8; 4; 5; 5; 4; 4 | >.05 |
| SECONDARY Change in Pain Interference (Micro-level) |
-1.61; -0.13; 0.23; 0.44; 0.81; -1.38 | >.05 |
| SECONDARY Change in Affect (Micro-level) |
0.11; 0.21; -0.01; -0.15; 0.18; -0.01 | >.05 |
| SECONDARY Change in Physical Function |
0.4; 1.7; 1.5; -0.6; 1.4; 0.9 | >.05 |
| SECONDARY Change in Sleep Quality |
-3.9; 0.3; 0.8; -3.4; -0.4; -0.8 | >.05 |
| SECONDARY Change in Pain Interference (Macro-level) |
-4.8; -6.6; -3.1; -4.6; -2.9; -2.1 | >.05 |
| SECONDARY Change in Affect (Macro-level) |
0.6; 1.8; 0.4; -2.1; -1.5; -0.6 | >.05 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03916276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.