Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone cognitive behavior therapy
Telephone pain education
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring pain, chronic pain, cognitive therapy, telehealth
Eligibility Criteria
Inclusion Criteria:
To be eligible to participate in this study, potential subjects must have:
- access to a telephone
- documented pain for at least the past year
- a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
- pain condition must be stable
- must have no clear indication for specific medical/surgical intervention.
Exclusion Criteria:
Patients were excluded who were:
- acutely psychotic
- cognitively impaired
- showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- currently abusing alcohol or other drugs, including prescribed opioid pain medications
- patients were also excluded who had 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 CBT
Arm 2 - telephone education
Arm Description
telephone cognitive behavior therapy for pain management
telephone pain education
Outcomes
Primary Outcome Measures
Level of Functioning
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Depressive Symptoms
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Pain Behavior
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Pain Intensity
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Secondary Outcome Measures
Full Information
NCT ID
NCT01236196
First Posted
November 1, 2010
Last Updated
December 12, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01236196
Brief Title
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Official Title
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (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
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Detailed Description
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) 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.
Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.
Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.
Major hypothesis:
Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).
Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain.
Secondary hypothesis:
Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. 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
Chronic Pain
Keywords
pain, chronic pain, cognitive therapy, telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Telephone CBT
Arm Type
Experimental
Arm Description
telephone cognitive behavior therapy for pain management
Arm Title
Arm 2 - telephone education
Arm Type
Active Comparator
Arm Description
telephone pain education
Intervention Type
Behavioral
Intervention Name(s)
Telephone cognitive behavior therapy
Intervention Description
Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
Intervention Type
Behavioral
Intervention Name(s)
Telephone pain education
Intervention Description
Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
Primary Outcome Measure Information:
Title
Level of Functioning
Description
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Time Frame
Baseline, 46 weeks
Title
Depressive Symptoms
Description
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Time Frame
Baseline, 46 weeks
Title
Pain Behavior
Description
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Time Frame
Baseline, 46 weeks
Title
Pain Intensity
Description
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Time Frame
Baseline, 46 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible to participate in this study, potential subjects must have:
access to a telephone
documented pain for at least the past year
a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
pain condition must be stable
must have no clear indication for specific medical/surgical intervention.
Exclusion Criteria:
Patients were excluded who were:
acutely psychotic
cognitively impaired
showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
currently abusing alcohol or other drugs, including prescribed opioid pain medications
patients were also excluded who had 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
Learn more about this trial
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
We'll reach out to this number within 24 hrs