Telephone Cognitive Behavior Therapy for OEF Veterans With Pain

Chronic Pain Clinical Trial

Official title:

Telephone Cognitive Behavior Therapy for OEF Veterans With Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236196
• Other study ID #: D7658-I
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: December 12, 2014
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Telephone cognitive behavior therapy
Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
• Telephone pain education
Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).

Locations

Country	Name	City	State
United States	VA Medical Center, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Depressive Symptoms	Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)	Baseline, 46 weeks	No
Primary	Pain Behavior	Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior	Baseline, 46 weeks	No
Primary	Pain Intensity	Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity	Baseline, 46 weeks	No