Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain

Not Applicable

Completed

• Conditions: Phantom Limb
• Interventions: Behavioral: Cognitive Behavioral Therapy and Mirror Retraining; Behavioral: Supportive therapy; Behavioral: Mirror retraining

• Registration Number: NCT00731614
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Study Start: 2008-11
• Primary Completion: 2011-09
• Study Completion: 2012-12
• Results First Submitted: 2015-03-03
• Results First Submitted QC: 2015-06-01
• Results First Posted: 2015-06-18
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Mirror retraining	Cognitive Behavior Therapy + mirror retraining
Arm 1	Cognitive Behavioral Therapy and Mirror Retraining	Cognitive Behavior Therapy + mirror retraining
Arm 2	Supportive therapy	Supportive psychotherapy

Primary Outcome Measures

Name	Time	Method
Phantom Limb Pain Questionnaire	Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.	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

Name	Time	Method
Short Form-12 (SF-12)	Baseline, end of treatment (8 weeks after baseline)	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.

Trial Locations

Locations (3)

VA Medical Center, Long Beach; 🇺🇸 Long Beach, California, United States

VA San Diego Healthcare System, San Diego; 🇺🇸 San Diego, California, United States

VA Medical Center, San Francisco; 🇺🇸 San Francisco, California, United States