The proposed study will be a pilot randomized controlled trial comparing treatment as usual (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing persistent post-operative pain. The ACT intervention is a single individual therapy session scheduled two weeks following surgery. Potential participants will be recruited from the University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the study is 72 participants. Study measures will consist of self-report questionnaires and medical record data. Data will be collected prior to surgery, one-week after surgery, and 3 months after surgery.
Psychological interventions addressing depression, anxiety, and psychological approaches to pain management in pre-surgical patients may serve to prevent the development of persistent post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing the impairing impact of chronic pain and in treating depression and anxiety. ACT is a behavior therapy incorporating mindfulness, which aims to increase psychological flexibility via facilitating psychological acceptance and committed action in the direction of one's personally identified values. ACT has also shown promise in brief interventions, including a one day ACT workshop with patients with comorbid migraine and depression. The current study proposes to identify pre-operative breast cancer patients who are at increased risk for developing persistent post-surgical pain and to offer a brief ACT intervention with the aim of reducing the incidence of persistence post-surgical pain and psychological sequela.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
62
Single 2-hour individual Acceptance and Commitment Therapy coping skills session.
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Numeric Rating Scale
Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)
Time frame: 3-months following surgery
The Brief Pain Inventory (BPI: pain severity)
Pain severity: four items: Average pain, worst in 24 hours, least in 24 hours, and right now (on a 0-10 scale)
Time frame: 3-months following surgery
The Brief Pain Inventory (BPI: pain interference)
Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes
Time frame: 3-months following surgery
Generalized Anxiety Disorder 7-item scale
Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)
Time frame: 3-months following surgery
Patient Health Questionnaire -8 item
Depression: scores range from 0 (low depression) to 24 (high depression)
Time frame: 3-months following surgery
SF-12 Health Survey
Quality of Life: There are two subscales on this 12-item measure: the physical component summary and the mental component summary. Scores range from 0-100 with higher scores indicating better health.
Time frame: 3-months following surgery
Pain catastrophizing Scale
Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)
Time frame: 3-months following surgery
Chronic Pain Acceptance Questionnaire
Pain Acceptance: This 20 item scale has two subscales: Activity engagement (11 items) and Pain willingness (9 items), and a combined total score. Each item is rated on a scale of 0 -6. Higher scores indicate higher levels of acceptance.
Time frame: 3-months following surgery
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