Efficacy of Tailored Cognitive-Behavioral Therapy for Chr... | NCT00108381

Studies
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

NCT00108381

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Jul 2, 2014Estimated

Enrollment

162Actual

Phase

Not Applicable

Conditions

Back Pain

Interventions

tailored cognitive behavior therapy
standard care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Feb 2010Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 14, 2005

First Submission Date that Met QC Criteria

Apr 14, 2005

First Posted Date

Apr 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2014

Last Update Posted Date

Jul 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Standard and Tailored Conditions	Behavioral: tailored cognitive behavior therapy Behavioral: standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tailored cognitive behavior therapy	Behavioral	tailored psychological treatment	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Multiple standardized measures of key domains of the chronic pain experience		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert D. Kerns, PhD	VA Connecticut Health Care System (West Haven)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Health Care System (West Haven)		West Haven	Connecticut	06516	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22688600	Result	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.
24295024	Result	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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
D001416	Back Pain
D010146	Pain