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An ACT-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial
Sponsor: Second Xiangya Hospital of Central South University
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. 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.
Official title: Feasibility, Acceptability, and Preliminary Effects of an Acceptance and Commitment Therapy-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-04-10
Completion Date
2026-08-30
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Acceptance and Commitment Therapy
Session Outline Session 1: Diagnostic clarification and emotional stabilisation on admission; 45-60 minutes. Session 2: Preparation for induction and trauma stabilisation after the treatment plan is agreed and before induction; 45-60 minutes. Session 3: Acknowledgement of grief and voluntary remembrance within 24-48 hours after induction, adjusted to physical condition; 30-60 minutes. Session 4: Rehabilitation, self-care, and a family support plan on the day before discharge or the discharge day; within the 30-60-minute inpatient-session range. Session 5: Post-discharge physical and psychological safety review and continuity of support within 3 days after discharge; 20-30 minutes. Session 6: Values clarification and anxiety management at 2 weeks after discharge; 30-45 minutes. Session 7: Consolidation of self-care and connection to clinical, community, and peer resources at 1 month after discharge; 20-30 minutes. Session 8: Booster focusing on anxiety, future pregnancy concerns.
Locations (3)
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China