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Clinical Trials/NCT00371267
NCT00371267
Completed
Not Applicable

Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

US Department of Veterans Affairs1 site in 1 country101 target enrollmentOctober 2006
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
US Department of Veterans Affairs
Enrollment
101
Locations
1
Primary Endpoint
Short Form-12 Physical Health
Status
Completed
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
September 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Short Form-12 Physical Health

Time Frame: 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

Time Frame: 46 weeks

Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores

Secondary Outcomes

  • Pain Behavior Checklist Total Score(46 weeks)
  • Pain Intensity Rating(46 weeks)
  • Beck Depression Inventory (BDI)-2 Total Score(46 weeks)

Study Sites (1)

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