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Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108381
First Posted: April 15, 2005
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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 VA Office of Research and Development:

Primary Outcome Measures:
  • Multiple standardized measures of key domains of the chronic pain experience [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108381


Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Robert D. Kerns, PhD VA Connecticut Health Care System (West Haven)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108381     History of Changes
Other Study ID Numbers: MHBS042-03
First Submitted: April 14, 2005
First Posted: April 15, 2005
Last Update Posted: July 2, 2014
Last Verified: June 2014

Keywords provided by VA Office of Research and Development:
chronic back pain
cognitive-behavioral
pain
stages of change

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