Telephone Cognitive Behavior Therapy for OEF Veterans With Pain

NCT01236196 | Completed Results DMC

• 1 other identifier: D7658-I
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.

Conditions

Chronic Pain

Keywords

pain; chronic pain; cognitive therapy; telehealth

Outcome Measures

Primary Outcomes (4)

• Level of Functioning

  Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning

  Baseline, 46 weeks

• Depressive Symptoms

  Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)

  Baseline, 46 weeks

• Pain Behavior

  Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior

  Baseline, 46 weeks

• Pain Intensity

  Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity

  Baseline, 46 weeks

Study Arms (2)

Arm 1 - Telephone CBT

EXPERIMENTAL

telephone cognitive behavior therapy for pain management

Behavioral: Telephone cognitive behavior therapy

Arm 2 - telephone education

ACTIVE COMPARATOR

telephone pain education

Behavioral: Telephone pain education

Interventions

Telephone cognitive behavior therapy BEHAVIORAL

Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).

Arm 1 - Telephone CBT

Telephone pain education BEHAVIORAL

Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).

Arm 2 - telephone education

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible to participate in this study, potential subjects must have:
• access to a telephone
• documented pain for at least the past year
• a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
• pain condition must be stable
• must have no clear indication for specific medical/surgical intervention.

You may not qualify if:

• Patients were excluded who were:
• acutely psychotic
• cognitively impaired
• showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
• currently abusing alcohol or other drugs, including prescribed opioid pain medications
• patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The fact that this study was conducted in northern California may have posed some threat to external validity when applying these findings to the nationwise VA system.

Results Point of Contact

• Title: Dr. Timothy Carmody
• Organization: San Francisco VA Medical Center

Timothy.Carmody@va.gov

415-221-4810

Study Officials

• Timothy Carmody, PhD

  VA Medical Center, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 8, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 23, 2014
• Results First Posted: December 23, 2014

Record last verified: 2014-12

Locations

US (1)