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

NCT07538011 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Second Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538011 on ClinicalTrials.gov