Clinical trial NCT04859686: Acupuncture and Mindfulness Based Stress Reduction for Wellness
Official title: Acupuncture and Meditation for Wellness (AMWELL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Depression
Acupuncture
Mindfulness-based stress reduction
Child abuse survivors
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2021-04-26
Enrollment: 77
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Checklist 4 (PCL-IV) Score
timeFrame: Week 4, 8 and 12
measure: Beck Depression Inventory (BDI-II) Score
timeFrame: Week, 4, 8 and 12
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI Score
timeFrame: Week 4, 8 and 12
measure: The Mindfulness Attention Awareness Scale (MAAS) Score
timeFrame: Week 4, 8 and 12
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, Baltimore
name: Brian Berman, MD
role: PRINCIPAL_INVESTIGATOR
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