Acupuncture and Mindfulness Based Stress Reduction for Wellness (AMWELL)

July 2, 2021 updated by: Uniformed Services University of the Health Sciences

Acupuncture and Meditation for Wellness (AMWELL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Participants underwent intervention.
Behavioral: Mindfulness-Based Stress Reduction
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.
Other Names:
  • MBSR
Procedure: Acupuncture Treatment

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.
No Intervention: Waitlist
Participants received no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist 4 (PCL-IV) Score
Time Frame: 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.
Week 4, 8 and 12
Beck Depression Inventory (BDI-II) Score
Time Frame: 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.
Week, 4, 8 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI Score
Time Frame: 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.
Week 4, 8 and 12
The Mindfulness Attention Awareness Scale (MAAS) Score
Time Frame: 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.
Week 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniformed Services University of the Health Sciences

Investigators

  • Principal Investigator: Brian Berman, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 30, 2010

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HP-00043308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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