Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Study Overview
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Brief Summary
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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
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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

Official Title
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Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Telephone-delivered Cognitive Behavior Therapy
* Other: Telephone-delivered Patient Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Telephone-delivered CBT<br>Telephone-delivered cognitive behavior therapy for pain management | Behavioral: Telephone-delivered Cognitive Behavior Therapy<br>* Telephone-delivered cognitive behavior therapy for pain management<br>|
| Active Comparator: Arm 2: Telephone patient education<br>Telephone-delivered patient education regarding management of chronic pain | Other: Telephone-delivered Patient Education<br>* Telephone-delivered patient education regarding chronic pain<br>* Other names: Patient education regarding pain management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-12 Physical Health | 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 | 46 weeks | 
| Short Form-12 Mental Health | Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores | 46 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy, pain