Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
Primary Purpose
Phantom Limb
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy and Mirror Retraining
Supportive therapy
Mirror retraining
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb focused on measuring cognitive therapy, mirror training, nondirective therapy, veterans, amputees
Eligibility Criteria
Inclusion Criteria:
- Adult (21or over)
- unilateral amputation at or above wrist or ankle
- phantom limb pain occurring at least weekly
- living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
- able to read and speak English
Exclusion Criteria:
- Current alcohol or drug dependence
- active psychosis
- medical problems that preclude participation
- current enrollment in behavioral pain management
Sites / Locations
- VA Medical Center, Long Beach
- VA San Diego Healthcare System, San Diego
- VA Medical Center, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Cognitive Behavior Therapy + mirror retraining
Supportive psychotherapy
Outcomes
Primary Outcome Measures
Phantom Limb Pain Questionnaire
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
Secondary Outcome Measures
Short Form-12 (SF-12)
the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health.
Full Information
NCT ID
NCT00731614
First Posted
August 5, 2008
Last Updated
October 15, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00731614
Brief Title
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
Official Title
Psychosocial and Visual Feedback Intervention for Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.
Detailed Description
The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.
Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.
The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.
Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb
Keywords
cognitive therapy, mirror training, nondirective therapy, veterans, amputees
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy + mirror retraining
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Supportive psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy and Mirror Retraining
Intervention Description
Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy
Other Intervention Name(s)
Non-directive therapy
Intervention Description
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Mirror retraining
Other Intervention Name(s)
Mirror box training
Intervention Description
Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain
Primary Outcome Measure Information:
Title
Phantom Limb Pain Questionnaire
Description
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
Secondary Outcome Measure Information:
Title
Short Form-12 (SF-12)
Description
the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health.
Time Frame
Baseline, end of treatment (8 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (21or over)
unilateral amputation at or above wrist or ankle
phantom limb pain occurring at least weekly
living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
able to read and speak English
Exclusion Criteria:
Current alcohol or drug dependence
active psychosis
medical problems that preclude participation
current enrollment in behavioral pain management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. McQuaid, PhD MS BA
Organizational Affiliation
VA Medical Center, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
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
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
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