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

VA Office of Research and Development

Status: Completed

Conditions: Phantom Limb

Treatments: Behavioral: Mirror retraining; Behavioral: Cognitive Behavioral Therapy and Mirror Retraining; Behavioral: Supportive therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00731614

F6441-R

UCSD IRB 080898 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

Arm 1

Experimental group

Description:

Cognitive Behavior Therapy + mirror retraining

Treatment:

Behavioral: Mirror retraining

Behavioral: Cognitive Behavioral Therapy and Mirror Retraining

Arm 2

Active Comparator group

Description:

Supportive psychotherapy

Treatment:

Behavioral: Supportive therapy