Effects of an Acceptance and Commitment Therapy-Based Psychosocial Intervention on Mental Health of Women With Perinatal Loss: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Perinatal Grief
研究概览
简要总结
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary effects of an Acceptance and Commitment Therapy (ACT)-based psychosocial intervention for women who have experienced perinatal loss (miscarriage, stillbirth, or neonatal death). The intervention is a 4-week programme delivered in a mixed format: four in-person sessions (hospital setting, one-on-two with spouse/significant other) and two videoconferencing sessions (post-discharge, one-on-one), plus a 30-minute booster session one month after completion. Outcome assessments will occur at baseline (pre-intervention), immediately post-intervention, and three months post-intervention. Primary feasibility and acceptability metrics include recruitment, retention, session attendance, and participant-rated satisfaction. Preliminary effectiveness outcomes include perinatal grief, post-traumatic stress, depression, anxiety, psychological flexibility, and perceived social support. A qualitative component (semi-structured interviews) will explore participants' experiences and suggestions for refinement.
详细描述
Background Perinatal loss, including miscarriage, stillbirth, and neonatal death, is a profound traumatic event affecting approximately 15-20% of pregnancies. Women who experience perinatal loss are at elevated risk for prolonged grief disorder, major depressive disorder, post-traumatic stress disorder, and anxiety disorders. Although maternal mental health has gained increasing attention in China, evidence-based, culturally adapted psychosocial interventions for perinatal loss remain scarce. Preliminary surveys by our research team indicate a strong need for grief support among bereaved women, yet healthcare providers (midwives and nurses) lack the knowledge and skills to deliver such support.
Acceptance and Commitment Therapy (ACT), a third-wave cognitive behavioural approach, has shown benefits for individuals experiencing grief and trauma by increasing psychological flexibility-an empirically supported process linked to improved mental health and adaptive coping. ACT targets six core processes: acceptance, cognitive defusion, contact with the present moment, self-as-context, values clarification, and committed action. However, prior trials in perinatal loss populations remain limited, and no culturally adapted ACT-based intervention has been evaluated in the Chinese context.
Intervention This study tests a 4-week ACT-based psychosocial intervention delivered across six sessions (45-60 minutes each), plus a 30-minute booster session one month after the final session. The intervention integrates four thematic components: (1) perinatal loss health education; (2) ACT-based grief and emotion management (acceptance, defusion, present-moment awareness, values, committed action); (3) postpartum rehabilitation mindfulness yoga; and (4) social support from significant others.
Delivery format is mixed to accommodate the inpatient-to-outpatient transition:
Sessions 1-4: In-person, hospital setting, one-on-two format (woman plus spouse/significant other), covering the inpatient period (admission, induction procedure, postoperative recovery).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years
- •Experienced perinatal loss (including miscarriage, stillbirth, or early neonatal death) within the past 12 months
- •Able to read and communicate in Chinese
- •Willing and able to provide written informed consent
排除标准
- •Current diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder acute episode, psychotic disorder)
- •Active suicidal ideation with plan or intent, as assessed by clinical judgment or PHQ-9 item 9 score ≥1
- •Concurrent participation in other systematic psychotherapy or psychosocial intervention
- •Cognitive impairment that precludes understanding of the intervention content
研究组 & 干预措施
intervention group
Participants receive a 4-week ACT-based psychosocial intervention (6 sessions, 45-60 min each) plus a 30-minute booster session. Delivery is mixed: sessions 1-4 in-person (hospital, with spouse/significant other); sessions 5-6 remote (videoconferencing, woman only). Content covers ACT-based grief management, mindfulness yoga, and social support. Participants receive a workbook with home practice materials.
干预措施: Acceptance and Commitment Therapy (Behavioral)
Control group
Participants in this arm receive standard perinatal care as provided by the hospital, including routine medical management, nursing care, and standard discharge instructions. No additional psychosocial intervention is provided as part of this study.
结局指标
主要结局
Perinatal Grief
时间窗: This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.
Measured by the 15-item Perinatal Grief Scale Short Form (15-PGS-SF; Li et al., 2025). Higher scores indicate more severe grief symptoms.
次要结局
- Depressive Symptoms(This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.)
- Anxiety Symptoms(This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.)
- Post-Traumatic Stress Symptoms(This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.)
- Psychological Flexibility(This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.)
- Perceived Social Support(This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.)
研究者
Liyang
Head Nurse of the Department
Second Xiangya Hospital of Central South University