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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSecond Xiangya Hospital of Central South University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Depressive Symptoms

Measured by the Patient Health Questionnaire-9 (PHQ-9; Wang et al., 2014). Higher scores indicate more severe depressive symptoms.

Time frame
This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.
2

Anxiety Symptoms

Measured by the Generalized Anxiety Disorder-7 (GAD-7; Zeng et al., 2013). Higher scores indicate more severe anxiety symptoms.

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

Post-Traumatic Stress Symptoms

Measured by the Impact of Event Scale-Revised (IES-R; Wu \& Chan, 2004). Higher scores indicate more severe post-traumatic stress symptoms.

Time frame
This outcome will be assessed before the intervention, immediately after the intervention ends, and 3 months after the intervention.
4

Psychological Flexibility

Measured by the Psy-Flex-C (Li et al., 2024a). Higher scores indicate greater psychological flexibility.

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

Other outcomes

1

Intervention Satisfaction

Measured by an adapted 18-item Chinese Standardized Client Satisfaction Scale (C-SCS; Liu \& Chen, 2022). Items are rated on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied). Higher scores indicate greater satisfaction with the intervention.

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

Sponsors and contacts

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