Acupuncture and Mindfulness Based Stress Reduction for Wellness

PTSD Clinical Trial

— AMWELL  

Official title:

Acupuncture and Meditation for Wellness (AMWELL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859686
• Other study ID #: HP-00043308
• Status: Completed
• Phase: N/A
• Start date: September 1, 2008
• Est. completion date: October 30, 2010

Study information

• Verified date: April 2021
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 30, 2010
• Est. primary completion date: October 1, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences

References & Publications (49)

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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