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

NCT ID: NCT00731614

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Phantom Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Cognitive Behavior Therapy + mirror retraining

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy and Mirror Retraining

Intervention Type: BEHAVIORAL

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.

Mirror retraining

Intervention Type: BEHAVIORAL

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

Arm 2

Supportive psychotherapy

Group Type: ACTIVE_COMPARATOR

Supportive therapy

Intervention Type: BEHAVIORAL

Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.

Interventions

Cognitive Behavioral Therapy and Mirror Retraining

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

Supportive therapy

Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.

Intervention Type: BEHAVIORAL

Mirror retraining

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Non-directive therapy; Mirror box training

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R. McQuaid, PhD MS BA

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, San Francisco

Locations

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

Countries

United States

Other Identifiers

UCSD IRB 080898

Identifier Type: OTHER

Identifier Source: secondary_id

F6441-R

Identifier Type: -

Identifier Source: org_study_id