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Acupuncture and Mindfulness Based Stress Reduction for Wellness (AMWELL)

Uniformed Services University (USU) logo

Uniformed Services University (USU)

Status

Completed

Conditions

PTSD

Treatments

Procedure: Acupuncture Treatment
Behavioral: Mindfulness-Based Stress Reduction

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04859686
HP-00043308

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

77 participants in 2 patient groups

Treatment
Experimental group
Description:
Participants underwent intervention.
Treatment:
Behavioral: Mindfulness-Based Stress Reduction
Procedure: Acupuncture Treatment
Waitlist
No Intervention group
Description:
Participants received no intervention.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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