Effects of a Acceptance and Commitment Therapy-Based Psychosocial Intervention on Mental Health of Women With Perinatal Loss: A Pilot Randomised Controlled Trial

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.

NCT Number	NCT07538011
Lead Sponsor	Second Xiangya Hospital of Central South University
Conditions	ACT, Perinatal Loss, Mental Health
Enrollment	88 participants
Start Date	2026-06-01
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-30