Clinical trial NCT01236196: Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Official title: Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: pain
chronic pain
cognitive therapy
telehealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-11-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Level of Functioning
timeFrame: Baseline, 46 weeks
measure: Depressive Symptoms
timeFrame: Baseline, 46 weeks
measure: Pain Behavior
timeFrame: Baseline, 46 weeks
measure: Pain Intensity
timeFrame: Baseline, 46 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
Study officials:
affiliation: VA Medical Center, San Francisco
name: Timothy Carmody, PhD
role: PRINCIPAL_INVESTIGATOR
References: