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

NCT07538011 | Not Yet Recruiting

• 1 other identifier: LYEC2025
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

ACT; Perinatal Loss; Mental Health

Keywords

ACT; Mental Health; perinatal loss; Pilot RCT

Outcome Measures

Primary Outcomes (1)

• Perinatal Grief

  Measured by the 15-item Perinatal Grief Scale Short Form (15-PGS-SF; Li et al., 2025). Higher scores indicate more severe grief symptoms.

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

Secondary Outcomes (5)

• Depressive Symptoms

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

• Anxiety Symptoms

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

• Post-Traumatic Stress Symptoms

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

• Psychological Flexibility

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

• Perceived Social Support

  This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.

Other Outcomes (1)

• Intervention Satisfaction

  This outcome will be assessed immediately after the intervention ends and 3 months after the intervention.

Study Arms (2)

intervention group

EXPERIMENTAL

Participants receive a 4-week ACT-based psychosocial intervention (6 sessions, 45-60 min each) plus a 30-minute booster session. Delivery is mixed: sessions 1-4 in-person (hospital, with spouse/significant other); sessions 5-6 remote (videoconferencing, woman only). Content covers ACT-based grief management, mindfulness yoga, and social support. Participants receive a workbook with home practice materials.

Behavioral: Acceptance and Commitment Therapy

Control group

NO INTERVENTION

Participants in this arm receive standard perinatal care as provided by the hospital, including routine medical management, nursing care, and standard discharge instructions. No additional psychosocial intervention is provided as part of this study.

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years
• Experienced perinatal loss (including miscarriage, stillbirth, or early neonatal death) within the past 12 months
• Spouse/partner willing to participate throughout the entire study
• Able to read and communicate in Chinese
• Willing and able to provide written informed consent

You may not qualify if:

• Current diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder acute episode, psychotic disorder)
• Active suicidal ideation with plan or intent, as assessed by clinical judgment or PHQ-9 item 9 score ≥1
• Concurrent participation in other systematic psychotherapy or psychosocial intervention
• Cognitive impairment that precludes understanding of the intervention content

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yang Li

CONTACT

+85 15200858727; 503428@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse of the Department

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)