Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108381
First received: April 14, 2005
Last updated: July 1, 2014
Last verified: June 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Resource links provided by NLM:


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
Study Completion Date: September 2013
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Robert D. Kerns, PhD VA Connecticut Health Care System (West Haven)
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108381     History of Changes
Other Study ID Numbers: MHBS042-03
Study First Received: April 14, 2005
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic back pain
cognitive-behavioral
pain
stages of change

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014