Acupuncture and Mindfulness Based Stress Reduction for Wellness

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Mindfulness-Based Stress Reduction; Procedure: Acupuncture Treatment

• Registration Number: NCT04859686
• Lead Sponsor: Uniformed Services University of the Health Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-09-01
• Primary Completion: 2009-10-01
• Study Completion: 2010-10-30
• Study First Submitted: 2020-10-23
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Mindfulness-Based Stress Reduction	Participants underwent intervention.
Treatment	Acupuncture Treatment	Participants underwent intervention.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist 4 (PCL-IV) Score	Week 4, 8 and 12	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.
Beck Depression Inventory (BDI-II) Score	Week, 4, 8 and 12	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.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI Score	Week 4, 8 and 12	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.
The Mindfulness Attention Awareness Scale (MAAS) Score	Week 4, 8 and 12	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.