Living in Full Even With Pain Study

NCT03916276 | Completed Results DMC

• 2 other identifiers: STUDY00006474R01AT008559-02S1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Chronic Pain

Keywords

Chronic Pain; Opioid; Heterogeneous Pain; Musculoskeletal Pain; Mindfulness Meditation; Behavioral Activation; Cognitive Therapy; Telehealth; Opioid Misuse; Mechanisms

Outcome Measures

Primary Outcomes (1)

• Change in Morphine Milligram Equivalent (MME) Average Daily Dose

  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).

  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 (6)

• 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 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 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 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 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)

Other Outcomes (10)

• Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism)

  ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported

• Change in Non-Judgment (Cognitive Process Mechanism, 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 Catastrophizing (Cognitive Content Mechanism, Micro-level)

  Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Study Arms (3)

Cognitive Therapy (CT) Condition

ACTIVE COMPARATOR

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)

Mindfulness Meditation (MM) Condition

ACTIVE COMPARATOR

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)

Behavioral Activation (BA) Condition

ACTIVE COMPARATOR

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: Behavioral Activation (BA)

Interventions

Cognitive Therapy (CT) BEHAVIORAL

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.

Cognitive Therapy (CT) Condition

Mindfulness Meditation (MM) BEHAVIORAL

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.

Mindfulness Meditation (MM) Condition

Behavioral Activation (BA) BEHAVIORAL

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.

Behavioral Activation (BA) Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• The University of Queensland: collaborator
• Medical University of South Carolina: collaborator
• Rush University: collaborator

Study Sites (1)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Day MA, Ciol MA, Ehde DM, Mendoza ME, Borckardt J, Newman AK, Chan JF, Friedly JL, Reed DE 2nd, Drever SA, Burns J, Thorn BE, Jensen MP. The Effects of Psychological Treatments for Chronic Pain on Reducing Opioid Use in People at Risk for Opioid Misuse: A Randomized Feasibility Trial. Pain Pract. 2026 Jan;26(1):e70107. doi: 10.1111/papr.70107.

  PMID: 41230568 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Opioid-Related Disorders

Interventions

Cognitive Behavioral Therapy; Mindfulness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Melissa Day, Co-Principal Investigator
• Organization: The University of Queensland

m.day@uq.edu.au

+61 7 3365 6421

Study Officials

• Mark Jensen, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

• Melissa Day, Ph.D.

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: June 16, 2020
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
• Access Criteria: We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)