Telephone Cognitive Behavior Therapy for OEF Veterans With Pain

NCT ID: NCT01236196

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-09-30

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.

Detailed Description

In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.

Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.

Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.

Major hypothesis:

Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).

Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain.

Secondary hypothesis:

Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.

Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.

To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized 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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - Telephone CBT

telephone cognitive behavior therapy for pain management

Group Type: EXPERIMENTAL

Telephone cognitive behavior therapy

Intervention Type: BEHAVIORAL

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

Arm 2 - telephone education

telephone pain education

Group Type: ACTIVE_COMPARATOR

Telephone pain education

Intervention Type: BEHAVIORAL

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

Interventions

Telephone cognitive behavior therapy

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

Intervention Type: BEHAVIORAL

Telephone pain education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Carmody, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, San Francisco

Locations

VA Medical Center, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

D7658-I

Identifier Type: -

Identifier Source: org_study_id