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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: October 29, 2014
Last verified: October 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 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.


Condition Intervention
Pain
Behavioral: Telephone-delivered Cognitive Behavior Therapy
Other: Telephone-delivered Patient 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:
  • Short Form-12 Physical Health [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI)-2 Total Score [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
    Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression

  • Pain Behavior Checklist Total Score [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
    Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior

  • Pain Intensity Rating [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
    Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain


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 CBT
Telephone-delivered cognitive behavior therapy for pain management
Behavioral: Telephone-delivered Cognitive Behavior Therapy
Telephone-delivered cognitive behavior therapy for pain management
Active Comparator: Arm 2: Telephone patient education
Telephone-delivered patient education regarding management of chronic pain
Other: Telephone-delivered Patient Education
Telephone-delivered patient education regarding chronic pain
Other Name: Patient education regarding pain management

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

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 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.
  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
Results First Received: October 24, 2014
Last Updated: October 29, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2014