NCT00108381

Brief Summary

This clinical trial compares two psychological treatments for back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

6.1 years

First QC Date

April 14, 2005

Last Update Submit

July 1, 2014

Conditions

Back Pain

Keywords

chronic back paincognitive-behavioralpainstages of change

Outcome Measures

Primary Outcomes (1)

  • Multiple standardized measures of key domains of the chronic pain experience

    12 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Standard and Tailored Conditions

Behavioral: tailored cognitive behavior therapyBehavioral: standard care

Interventions

tailored cognitive behavior therapyBEHAVIORAL

tailored psychological treatment

Arm 1
standard careBEHAVIORAL

standard psychological treatment

Arm 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic back pain for at least 6 months
  • Treatment by medication or physical therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

Related Publications (4)

  • 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.

    PMID: 22688600RESULT

  • 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.

    PMID: 24295024RESULT

  • 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.

    PMID: 25119513DERIVED

  • 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.

    PMID: 24979313DERIVED

MeSH Terms

Conditions

Back PainPain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Robert D. Kerns, PhD

    VA Connecticut Health Care System (West Haven)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

January 1, 2004

Primary Completion

February 1, 2010

Study Completion

September 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

US(1)