Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Pain Clinical Trial

Official title:

Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371267
• Other study ID #: F4281-I
• Status: Completed
• Phase: N/A
• First received: August 31, 2006
• Last updated: October 29, 2014
• Start date: October 2006
• Est. completion date: September 2010

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Behavioral:
• Telephone-delivered Cognitive Behavior Therapy
Telephone-delivered cognitive behavior therapy for pain management

Other:
• Telephone-delivered Patient Education
Telephone-delivered patient education regarding chronic pain

Locations

Country	Name	City	State
United States	VA Medical Center, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carmody TP, Duncan CL, Huggins J, Solkowitz SN, Lee SK, Reyes N, Mozgai S, Simon JA. Telephone-delivered cognitive-behavioral therapy for pain management among older military veterans: a randomized trial. Psychol Serv. 2013 Aug;10(3):265-75. doi: 10.1037/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Pain Intensity Rating	Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain	46 weeks	No