Living in Full Even With Pain Study

NCT ID: NCT03916276

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2023-01-25

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.

Conditions

Musculoskeletal Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Therapy (CT) Condition

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Therapy (CT)

Intervention Type: 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.

Mindfulness Meditation (MM) Condition

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness Meditation (MM)

Intervention Type: 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.

Behavioral Activation (BA) Condition

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.

Group Type: ACTIVE_COMPARATOR

Behavioral Activation (BA)

Intervention Type: 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.

Interventions

Cognitive Therapy (CT)

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.

Intervention Type: BEHAVIORAL

Mindfulness Meditation (MM)

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.

Intervention Type: BEHAVIORAL

Behavioral Activation (BA)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Rush University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mark Jensen

Professor, School of Medicine: Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Melissa Day, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

University of Washington, Ninth and Jefferson Building

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://sites.uw.edu/lifestudy/

Study website

Other Identifiers

R01AT008559-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006474

Identifier Type: -

Identifier Source: org_study_id