Back on Track to Healthy Living Study

NCT03687762 | Completed Results DMC

• 2 other identifiers: STUDY00003841R01AT008559
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Behavioral Activation (BA). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments. Treatment moderators will also be explored.

Conditions

Chronic Pain

Keywords

chronic pain; mechanisms; cognitive therapy; mindfulness meditation; behavioral activation

Outcome Measures

Primary Outcomes (2)

• Change in Pain Interference (Micro-level Change)

  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 for a total raw score from 5-25. 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 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.

  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 (Macro-level Change)

  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 for a total raw score from 5-25. 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 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.

  Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Secondary Outcomes (9)

• Change in Pain Intensity (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 Mood (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, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

• Change in Sleep Quality

  Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

• Change in Depression Severity

  Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Other Outcomes (5)

• Change in Pain Catastrophizing (i.e., 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

• Change in Non-Judgment (i.e., 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 Activity Level (Actigraph, Vector Magnitude Average Counts)

  Worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 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;
• Endorse having low back pain as a primary or secondary pain problem in the past 6 months;
• Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
• Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
• Chronic pain interference for general activities ≥3 on a 10-point scale for the past 3 months;
• Able to read, speak, and understand English;
• If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; 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, or hospitalization 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 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
• Rush University: collaborator
• Medical University of South Carolina: collaborator
• The University of Queensland: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• Day MA, Ehde DM, Burns J, Ward LC, Friedly JL, Thorn BE, Ciol MA, Mendoza E, Chan JF, Battalio S, Borckardt J, Jensen MP. A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol. Contemp Clin Trials. 2020 Jun;93:106000. doi: 10.1016/j.cct.2020.106000. Epub 2020 Apr 14.

  PMID: 32302791 BACKGROUND

• Day MA, Ciol MA, Mendoza ME, Borckardt J, Ehde DM, Newman AK, Chan JF, Drever SA, Friedly JL, Burns J, Thorn BE, Jensen MP. The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial. BMC Med. 2024 Apr 12;22(1):156. doi: 10.1186/s12916-024-03383-2.

  PMID: 38609994 RESULT

• Day MA, Ward LC, Ehde DM, Mendoza ME, Phillips Reindel KM, Thorn BE, Bindicsova I, Jensen MP. Initial development and psychometric properties of the Therapist Quality Scale. Rehabil Psychol. 2024 Nov;69(4):326-334. doi: 10.1037/rep0000550. Epub 2024 Feb 15.

  PMID: 38358711 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy; Mindfulness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

This RCT compared three active treatments and lacked an inert (e.g., treatment as usual) and/or attention (e.g., support group) control condition; therefore, the potential effects of time and non-specific factors cannot be accounted for.

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 parallel design, 240-subject clinical trial to test the mechanisms of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with chronic pain who endorse low back pain as a primary or secondary pain problem.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 27, 2018
• Study Start: September 7, 2018
• 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)