Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

NCT ID: NCT00108381

Last Updated: 2014-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical trial compares two psychological treatments for back pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to examine the incremental efficacy of a patient-centered and tailored self-management treatment approach, Tailored Cognitive-Behavior Therapy (TCBT), for persons with chronic musculoskeletal pain. TCBT will be compared with a Standard Cognitive- Behavior Therapy (SCBT) condition. The hypothesis is that TCBT will be associated with improved outcomes following treatment. Outcome will be assessed by multiple standardized measures of key domains of the chronic pain experience. Secondary objectives are to examine the process of successful self-management treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Standard and Tailored Conditions

Group Type EXPERIMENTAL

tailored cognitive behavior therapy

Intervention Type BEHAVIORAL

tailored psychological treatment

standard care

Intervention Type BEHAVIORAL

standard psychological treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tailored cognitive behavior therapy

tailored psychological treatment

Intervention Type BEHAVIORAL

standard care

standard psychological treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic back pain for at least 6 months
* Treatment by medication or physical therapy

Exclusion Criteria

* Acute or life threatening physical illness
* Current alcohol or substance abuse or dependence
* Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert D. Kerns, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Health Care System (West Haven)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Finan PH, Burns JW, Jensen MP, Nielson WR, Kerns RD. Pain coping but not readiness to change is associated with pretreatment pain-related functioning. Clin J Pain. 2012 Oct;28(8):687-92. doi: 10.1097/AJP.0b013e3182400867.

Reference Type RESULT
PMID: 22688600 (View on PubMed)

Kerns RD, Burns JW, Shulman M, Jensen MP, Nielson WR, Czlapinski R, Dallas MI, Chatkoff D, Sellinger J, Heapy A, Rosenberger P. Can we improve cognitive-behavioral therapy for chronic back pain treatment engagement and adherence? A controlled trial of tailored versus standard therapy. Health Psychol. 2014 Sep;33(9):938-47. doi: 10.1037/a0034406. Epub 2013 Dec 2.

Reference Type RESULT
PMID: 24295024 (View on PubMed)

Burns JW, Nielson WR, Jensen MP, Heapy A, Czlapinski R, Kerns RD. Does Change Occur for the Reasons We Think It Does? A Test of Specific Therapeutic Operations During Cognitive-Behavioral Treatment of Chronic Pain. Clin J Pain. 2015 Jul;31(7):603-11. doi: 10.1097/AJP.0000000000000141.

Reference Type DERIVED
PMID: 25119513 (View on PubMed)

Burns JW, Nielson WR, Jensen MP, Heapy A, Czlapinski R, Kerns RD. Specific and general therapeutic mechanisms in cognitive behavioral treatment of chronic pain. J Consult Clin Psychol. 2015 Feb;83(1):1-11. doi: 10.1037/a0037208. Epub 2014 Jun 30.

Reference Type DERIVED
PMID: 24979313 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MHBS042-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CBT-CP for Veterans With SMI
NCT06758414 NOT_YET_RECRUITING NA
Treatment of Post-TBI Depression
NCT00211835 COMPLETED NA