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Completed

NCT Number: NCT00371267

Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone-delivered Cognitive Behavior Therapy

Behavioral

Telephone-delivered cognitive behavior therapy for pain management

Telephone-delivered Patient Education

Other

Telephone-delivered patient education regarding chronic pain

Other names: Patient education regarding pain management

Primary outcomes

  1. 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

  2. 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

  1. Beck Depression Inventory (BDI)-2 Total Score

    Time frame: 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

  2. Pain Behavior Checklist Total Score

    Time frame: 46 weeks

    Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior

  3. Pain Intensity Rating

    Time frame: 46 weeks

    Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2006
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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