Clinical Research Directory

An ACT-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial

This pilot randomised controlled trial evaluates the feasibility, acceptability, and preliminary effects of an Acceptance and Commitment Therapy (ACT)-based family psychosocial intervention for women requiring medically indicated induction of labour because of fetal or maternal health problems, together with their spouses as primary caregivers. The study is conducted at three tertiary hospitals in Changsha, Hunan, China. The target sample is 44 woman-spouse dyads, allocated 1:1 to usual care plus the intervention or usual care alone. The approximately 3-month intervention comprises eight sessions: four face-to-face hospital sessions lasting 30-60 minutes and four online dyadic sessions via Tencent Meeting lasting 20-45 minutes. The post-discharge online sessions (Sessions 5 to 8) are conducted within 3 days, in the second week, in the first month, and in the third month (booster session) following the patient's discharge. Outcomes are assessed at baseline before randomisation (T0) and within 1 week after intervention completion (T1), with corresponding assessment timing in the control group. Perinatal grief is the primary effectiveness outcome. Secondary outcomes include depression, anxiety, post-traumatic stress symptoms, psychological flexibility, health information literacy, mindful self-care, and perceived social support. Feasibility is assessed through recruitment, adherence, implementation, attrition, and reasons for withdrawal. Intervention-group dyads jointly complete an 17-item satisfaction questionnaire at T1 and are invited to qualitative interviews within 1 week after intervention completion.