A Feasibility Randomized Controlled Evaluation of a Mind-Body Dance Fitness Program for Improving Symptoms of Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Feasibility and acceptability
研究概览
简要总结
The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).
详细描述
The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 20-39 years
- •Have an infant 0-12 months old
- •Self-report clearance from provider to engage in physical activity following birth
- •Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
- •Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
- •English speaking
- •OULA-naïve
- •If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks
排除标准
- •Unable to be physically active
- •Current pregnancy
- •SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
- •Active suicidal attempt or plan identified on the SCID-5-RV
- •Suicide attempt in the past 6 months
- •Concurrent participation in another group dance fitness format
- •No access to Internet via computer, tablet, or smart phone
研究组 & 干预措施
Group dance fitness, OULA
Mind-body dance fitness group
干预措施: OULA, Mind-body Physical Activity (Other)
Waitlist Control
Waitlist control group
结局指标
主要结局
Feasibility and acceptability
时间窗: 7 months
Feasibility will be evaluated using recruitment, retention, OULA attendance, and treatment completion data, amd intervention fidelity. Feasibility of recruitment will be assessed through the number of participants eligible for randomization, proportion of participants randomized relative to the total number of referrals, and number of participants enrolled each month. Feasibility of intervention will be evaluated through treatment completion and retention rates, Feasibility of Intervention Measure (FIM) will be used at intervention completion. Fidelity assessment will be measured by OULA instructors completing an self-evaluation checklist. Women in the OULA group will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) will be collected at week 8. Acceptability will be assessed through reasons for withdrawal. Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) will be collected at week 8.
次要结局
- Changes in postpartum depression(7 months)
- Changes in postpartum anxiety(7 months)
研究者
Tracy Hellem
Associate Professor
Montana State University