Clinical trial NCT00371267: Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
Official title: Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: cognitive behavioral therapy
pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-09-04
Enrollment: 101
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka.

Detailed description: Chronic pain represents an epidemic in the United States and a serious public health problem, particularly among adults over the age of 55. In the Veterans Health Administration (VHA), nearly 50% of patients seen in primary care settings report disabling pain symptoms. Persistent pain in older adults is often associated with disability, emotional distress, and increased health care utilization and cost. Since an increase in the number of older adults is anticipated over the next two decades, the problem of chronic pain in this age group will take on increased importance.

Although cognitive behavior therapy (CBT) aimed at improving coping skills 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.

To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka. In Study Arm 1, patients received telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients received pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups received 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes were measured at mid-treatment (10 weeks), post-treatment (20 weeks), and at 3-month (32 weeks) and 6-month (46 weeks) follow-up. Outcome variables included measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain

Eligibility criteria: Inclusion Criteria:

Potential subjects must be:

* veterans enrolled in a VA primary care clinic
* at least 55 years of age
* have access to a telephone
* have documented pain for at least the past year
* a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
* Their pain condition must be stable and participants must have no clear indication for specific medical/surgical intervention.

Exclusion Criteria:

Patients were excluded who were:

* psychotic
* cognitively impaired
* show significant suicidal risk (history of multiple suicide attempts or actively suicidal)
* currently abusing alcohol or other drugs, including prescribed opioid pain medications
* voice impairment that would prevent participation in telephone counseling
* visual impairment that would prevent use of the workbook and completion of assessment materials.
* Patients will also be excluded who have an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.

Primary outcomes:
measure: Short Form-12 Physical Health
timeFrame: 46 weeks
measure: Short Form-12 Mental Health
timeFrame: 46 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI)-2 Total Score
timeFrame: 46 weeks
measure: Pain Behavior Checklist Total Score
timeFrame: 46 weeks
measure: Pain Intensity Rating
timeFrame: 46 weeks
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:
citation: Carmody TP, Duncan CL, Huggins J, Solkowitz SN, Lee SK, Reyes N, Mozgai S, Simon JA. Telephone-delivered cognitive-behavioral therapy for pain management among older military veterans: a randomized trial. Psychol Serv. 2013 Aug;10(3):265-275. doi: 10.1037/a0030944. Epub 2012 Dec 17.