Acupuncture and Mindfulness Based Stress Reduction for Wellness

NCT04859686 | Completed

• 1 other identifier: HP-00043308
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD

Keywords

PTSD; Depression; Acupuncture; Mindfulness-based stress reduction; Child abuse survivors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI Score

  Week 4, 8 and 12

• The Mindfulness Attention Awareness Scale (MAAS) Score

  Week 4, 8 and 12

Study Arms (2)

Treatment

EXPERIMENTAL

Participants underwent intervention.

Behavioral: Mindfulness-Based Stress Reduction; Procedure: Acupuncture Treatment

Waitlist

NO INTERVENTION

Participants received no intervention.

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Treatment

Acupuncture Treatment PROCEDURE

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.

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

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  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Mindfulness-Based Stress Reduction; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Complementary Therapies; Therapeutics

Study Officials

• Brian Berman, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: April 26, 2021
• Study Start: September 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 30, 2010
• Last Updated: July 8, 2021

Record last verified: 2021-04