Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371267
First received: August 31, 2006
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 will be conducted with 120 individuals, 55 years of age and older, who suffer 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.


Condition Intervention
Pain
Behavioral: Cognitive Behavior Therapy
Other: Pain Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: 20 weeks (end of treatment), 32 weeks, and 46 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Coping Skills [ Time Frame: 20 weeks (end of treatment), 32 weeks, and 46 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: October 2006
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Telephone-delivered cognitive behavior therapy for pain management
Behavioral: Cognitive Behavior Therapy
Telephone-delivered cognitive behavior therapy for pain management
Active Comparator: Arm 2
Telephone-delivered patient education regarding management of chronic pain
Other: Pain Education
Telephone-delivered education regarding chronic pain

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 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 will be conducted with 120 individuals, 55 years of age and older, who suffer 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 will receive telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients will receive pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups will receive 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes will be 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 will include measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures are based on the cognitive-behavioral model of chronic pain

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 will be excluded who are:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371267

Locations
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Investigators
Principal Investigator: Timothy Carmody, PhD VA Medical Center, San Francisco
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00371267     History of Changes
Other Study ID Numbers: F4281-I
Study First Received: August 31, 2006
Last Updated: January 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive behavioral therapy
pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014