Comparative Mechanisms of Psychosocial Chronic Pain Treatments

NCT02133976 | Completed DMC

• 1 other identifier: 12101001
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 1

Brief Summary

Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain; psychosocial interventions; mechanisms

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

  12 months

Secondary Outcomes (1)

• Activity level

  12 months

Study Arms (4)

cognitive therapy

ACTIVE COMPARATOR

Cognitive therapy will be delivered to decrease pain interference

Behavioral: cognitive therapy; Other: treatment as usual

mindfulness training

ACTIVE COMPARATOR

Mindfulness training will be delivered to decrease pain interference

Behavioral: mindfulness training; Other: treatment as usual

behavior therapy

ACTIVE COMPARATOR

Behavior therapy will be delivered to decrease pain interference

Behavioral: behavioral therapy; Other: treatment as usual

treatment as usual

ACTIVE COMPARATOR

Subjects will engage in their usual care for low back pain.

Other: treatment as usual

Interventions

cognitive therapy BEHAVIORAL

cognitive therapy

mindfulness training BEHAVIORAL

mindfulness training

behavioral therapy BEHAVIORAL

behavior therapy

treatment as usual OTHER

behavior therapy; cognitive therapy; mindfulness training; treatment as usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
• musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
• age between 18 and 75 years.

You may not qualify if:

• meet criteria for alcohol or substance abuse problems
• meet criteria for past or present psychotic or bipolar disorders
• inability to understand English well enough to complete questionnaires or to participate in therapy
• active suicidal ideation with intent
• pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Duke University: collaborator
• University of Alabama, Tuscaloosa: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• Gerhart J, Burns JW, Thorn B, Jensen M, Carmody J, Keefe F. Treatment mechanism and outcome decoupling effects in cognitive therapy, mindfulness-based stress reduction, and behavior therapy for chronic pain. Pain. 2025 Feb 1;166(2):408-419. doi: 10.1097/j.pain.0000000000003374. Epub 2024 Aug 30.

  PMID: 39226076 DERIVED

• Burns JW, Jensen MP, Thorn BE, Lillis TA, Carmody J, Gerhart J, Keefe F. Cognitive Therapy, Mindfulness-Based Stress Reduction, and Behavior Therapy for the Treatment of Chronic Pain: Predictors and Moderators of Treatment Response. J Pain. 2024 Jun;25(6):104460. doi: 10.1016/j.jpain.2024.01.003. Epub 2024 Jan 8.

  PMID: 38199593 DERIVED

• Burns JW, Jensen MP, Gerhart J, Thorn BE, Lillis TA, Carmody J, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for people with chronic low back pain: A comparative mechanisms study. J Consult Clin Psychol. 2023 Mar;91(3):171-187. doi: 10.1037/ccp0000801. Epub 2023 Feb 27.

  PMID: 36848061 DERIVED

• Burns JW, Jensen MP, Thorn B, Lillis TA, Carmody J, Newman AK, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. Pain. 2022 Feb 1;163(2):376-389. doi: 10.1097/j.pain.0000000000002357.

  PMID: 34074945 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy; Behavior Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John W Burns, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 8, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: July 1, 2019
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)