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

Condition(s) studied

Investigational drug(s) / intervention(s)

Acceptance and Commitment Therapy: 4-week ACT-based psychosocial intervention for women with perinatal loss. Six sessions (45-60 min) plus 30-min booster session at 1 month post-intervention. Four themes: perinatal loss health education; ACT-based grief and emotion management (acceptance, defusion, present-moment awareness, values, committed action); postpartum mindfulness yoga; social support from significant others. Delivery: Sessions 1-4 in-person (hospital, with spouse/partner); Sessions 5-6 remote videoconferencing (woman only); booster remote. Participants receive workbook with session summaries, homework, and QR codes linking to online mindfulness videos. Session Outline Care-pathway activation: recognition of confirmed or suspected loss, privacy preferences, safety screening, and a minimum handover record; this clinical process is not counted as a session. Session 1: Diagnostic clarification and emotional stabilisation on admission; 45-60 minutes. Session 2: Preparation for induction and trauma stabilisation aft

Study summary

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. Online sessions occur within 3 days, at 2 weeks, at 1 month, and at 3 months after discharge; the final session is a booster. 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 18-item satisfaction questionnaire at T1 and are invited to qualitative interviews within 1 week after intervention completion.

Eligibility

Primary outcome measure(s)

• Perinatal Grief — Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of 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.

Trial sites (3)

More Second Xiangya Hospital of Central South University trials in China

Other trials for the same condition