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Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tailored cognitive behavior therapy
standard care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring chronic back pain, cognitive-behavioral, pain, stages of change

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Health Care System (West Haven)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Standard and Tailored Conditions

Outcomes

Primary Outcome Measures

Multiple standardized measures of key domains of the chronic pain experience

Secondary Outcome Measures

Full Information

First Posted
April 14, 2005
Last Updated
July 1, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108381
Brief Title
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain
Official Title
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial compares two psychological treatments for back pain.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
chronic back pain, cognitive-behavioral, pain, stages of change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Standard and Tailored Conditions
Intervention Type
Behavioral
Intervention Name(s)
tailored cognitive behavior therapy
Intervention Description
tailored psychological treatment
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
standard psychological treatment
Primary Outcome Measure Information:
Title
Multiple standardized measures of key domains of the chronic pain experience
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Kerns, PhD
Organizational Affiliation
VA Connecticut Health Care System (West Haven)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22688600
Citation
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.
Results Reference
result
PubMed Identifier
24295024
Citation
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.
Results Reference
result
PubMed Identifier
25119513
Citation
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.
Results Reference
derived
PubMed Identifier
24979313
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

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