Acupuncture and Meditation for Wellness (AMWELL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- PTSD Checklist 4 (PCL-IV) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Treatment
Participants underwent intervention.
干预措施: Mindfulness-Based Stress Reduction (Behavioral)
Treatment
Participants underwent intervention.
干预措施: Acupuncture Treatment (Procedure)
Waitlist
Participants received no intervention.
结局指标
主要结局
PTSD Checklist 4 (PCL-IV) Score
时间窗: 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.
Beck Depression Inventory (BDI-II) Score
时间窗: 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.
次要结局
- Pittsburgh Sleep Quality Index (PSQI Score(Week 4, 8 and 12)
- The Mindfulness Attention Awareness Scale (MAAS) Score(Week 4, 8 and 12)