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Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-delivered Cognitive Behavior Therapy
Telephone-delivered Patient Education
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring cognitive behavioral therapy, pain

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical Center, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Telephone-delivered CBT

Arm 2: Telephone patient education

Arm Description

Telephone-delivered cognitive behavior therapy for pain management

Telephone-delivered patient education regarding management of chronic pain

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
Pain Behavior Checklist Total Score
Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior
Pain Intensity Rating
Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain

Full Information

First Posted
August 31, 2006
Last Updated
October 29, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00371267
Brief Title
Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
Official Title
Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
cognitive behavioral therapy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Telephone-delivered CBT
Arm Type
Experimental
Arm Description
Telephone-delivered cognitive behavior therapy for pain management
Arm Title
Arm 2: Telephone patient education
Arm Type
Active Comparator
Arm Description
Telephone-delivered patient education regarding management of chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Telephone-delivered Cognitive Behavior Therapy
Intervention Description
Telephone-delivered cognitive behavior therapy for pain management
Intervention Type
Other
Intervention Name(s)
Telephone-delivered Patient Education
Other Intervention Name(s)
Patient education regarding pain management
Intervention Description
Telephone-delivered patient education regarding chronic pain
Primary Outcome Measure Information:
Title
Short Form-12 Physical Health
Description
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
Time Frame
46 weeks
Title
Short Form-12 Mental Health
Description
Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores
Time Frame
46 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)-2 Total Score
Description
Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression
Time Frame
46 weeks
Title
Pain Behavior Checklist Total Score
Description
Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior
Time Frame
46 weeks
Title
Pain Intensity Rating
Description
Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain
Time Frame
46 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Carmody, PhD
Organizational Affiliation
VA Medical Center, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23244028
Citation
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):265-275. doi: 10.1037/a0030944. Epub 2012 Dec 17. Erratum In: Psychol Serv. 2013 Aug;10(3):297.
Results Reference
result

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Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

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