Acupuncture and Mindfulness Based Stress Reduction for Wellness

Study Overview
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Brief Summary
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AMWELL is a randomized, waitlist-controlled, pilot study to evaluate the comparative efficacy of Mindfulness Based Stress Reduction (MBSR) and Acupuncture (AT) to Wait-List Control (WL) in adult female survivors of childhood sexual abuse (CSA) experiencing symptoms of psychological distress.

Detailed Description
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Female CSA survivors at least 21 years old were recruited from newspaper ads, radio programs, study websites and various public announcements in the Baltimore, Md and surrounding area between September, 2008 to October, 2009.

Official Title
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Acupuncture and Meditation for Wellness (AMWELL)

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Procedure: Acupuncture Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female survivors of childhood sexual assault reported in a clinical interview (e.g., age at which the abuse began and continued, frequency and duration, and the perpetrator) At least 21 years old Ability to read and write in English Under the care of a licensed psychotherapist or physician for study duration Clinical approval for acupuncture or MBSD Ability to attend 80% of the sessions Willingness to practice skills 20-30 minutes per day, six days a week If taking psychotropic medication, on a stable dose for 30 days prior to baseline A score of 0.5 or greater on the Brief Symptom Inventory (BSI) Exclusion Criteria: Any major illness or psychiatric disorder Symptom severity as evidenced by a CGI-S score of 6 or 7 Current suicidal ideation Active alcoholism or drug dependency Current enrollment in another clinical trial Major surgery scheduled Plans to move from the area during the 12-week study period Current pregnancy, plans to become pregnant, or no means of birth control

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Participants underwent intervention. | Behavioral: Mindfulness-Based Stress Reduction<br>* The MBSR program included weekly 2.5-hour sessions in a group format over eight weeks, plus a 1-day retreat. Formal practices included several types of meditation, such as mindful breathing, sitting meditation, walking meditation, gentle hatha yoga, body scan, and mindful awareness. Participants were asked to practice at home for 20 minutes daily, six days a week.<br>* Other names: MBSR;Procedure: Acupuncture Treatment<br>* Participants received two treatments per week over eight weeks, 35-40 minutes each. At each treatment, participants were treated with 10 body and two ear points: seven major points on either the front or back of the body. The treatment position alternated between sessions, such that the first session was on the back, with the next session on the front, unless a physical limitation prevented alternation.<br>|
| No Intervention: Waitlist<br>Participants received no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist 4 (PCL-IV) Score | PCL-IV is a self-report measure of 17 DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) was obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely. Higher scores indicate worse symptoms of PTSD. Participants were evaluated by a study coordinator at a baseline visit, at 4 weeks for a mid-treatment measure, at 8 weeks for a posttreatment measure, and at 12 weeks for a one month follow-up assessment. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores. | Week 4, 8 and 12 | 
| Beck Depression Inventory (BDI-II) Score | The 21-item BDI-II is a widely-used, standardized, validated self-reporting measure of depressive symptom severity. It addresses affective, behavioral, biological, cognitive, and motivational symptoms of depression. Participants rated statements from 0 to 3 to indicate the level which best described the severity of the symptoms experienced. The ratings were summed to a total score, with ranges of 4-9 indicating normal, 10-18 mild, 9-29 moderate to severe, and ≥ 30 indicating severe. Scores range from 0 - 40. Higher scores indicate worse depressive symptoms. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores. | Week, 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI Score | The PSQI is a 19-item self-reported inventory providing measures of daytime dysfunction, sleep latency, duration, disturbance, quality, and efficiency, which are arranged into seven component scores. Each item is rated 0 (best) to 3 (worst); the component sums are added together, ranging from 0 (worst) to 21 (best), providing a global PSQI score. Higher scores indicate worse sleep quality. | Week 4, 8 and 12 | 
| The Mindfulness Attention Awareness Scale (MAAS) Score | The 15-item self-report MAAS measures mindfulness as open or receptive awareness and attention to the present. The questions ask about daily experiences (e.g., I snack without being aware that I'm eating.), with answers being measured on a Likert-scale of 1 (almost always) to 6 (almost never). Scores range from 15 - 90. Higher scores reflect higher levels of mindfulness. | Week 4, 8 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Acupuncture, Mindfulness-based stress reduction, Child abuse survivors