Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108381

Purpose

This clinical trial compares two psychological treatments for back pain.

Condition	Intervention
Back Pain	Behavioral: tailored cognitive behavior therapy Behavioral: standard care

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Multiple standardized measures of key domains of the chronic pain experience [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	162
Study Start Date:	January 2004
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Standard and Tailored Conditions	Behavioral: tailored cognitive behavior therapy tailored psychological treatment Behavioral: standard care standard psychological treatment

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108381

Locations

United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Robert D. Kerns, PhD

VA Connecticut Health Care System (West Haven)

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Kerns, Robert - Principal Investigator )
Study ID Numbers:	MHBS042-03
Study First Received:	April 14, 2005
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00108381 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

chronic back pain
cognitive-behavioral
pain
stages of change

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Pain
Back Pain

ClinicalTrials.gov processed this record on September 03, 2009