Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Not Applicable

Completed

Conditions: Pain

Interventions: Behavioral: Telephone-delivered Cognitive Behavior Therapy
Other: Telephone-delivered Patient Education

Registration Number: NCT00371267

Lead Sponsor: US Department of Veterans Affairs

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Telephone-delivered CBT	Telephone-delivered Cognitive Behavior Therapy	Telephone-delivered cognitive behavior therapy for pain management
Arm 2: Telephone patient education	Telephone-delivered Patient Education	Telephone-delivered patient education regarding management of chronic pain

Primary Outcome Measures

Name	Time	Method
Short Form-12 Physical Health	46 weeks	Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores
Short Form-12 Mental Health	46 weeks	Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores

Secondary Outcome Measures

Name	Time	Method
Pain Behavior Checklist Total Score	46 weeks	Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior
Pain Intensity Rating	46 weeks	Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain
Beck Depression Inventory (BDI)-2 Total Score	46 weeks	Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression