Clinical trial NCT00731614: 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
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb
Keywords: cognitive therapy
mirror training
nondirective therapy
veterans
amputees
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-08-11
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Phantom Limb Pain Questionnaire
timeFrame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
Secondary outcomes:
measure: Short Form-12 (SF-12)
timeFrame: Baseline, end of treatment (8 weeks after baseline)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Medical Center, Long Beach
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
Study officials:
affiliation: VA Medical Center, San Francisco
name: John R. McQuaid, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: