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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy
Behavioral4-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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Depressive Symptoms
Measured by the Patient Health Questionnaire-9 (PHQ-9; Wang et al., 2014). Higher scores indicate more severe depressive symptoms.
Anxiety Symptoms
Measured by the Generalized Anxiety Disorder-7 (GAD-7; Zeng et al., 2013). Higher scores indicate more severe anxiety symptoms.
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.
Psychological Flexibility
Measured by the Psy-Flex-C (Li et al., 2024a). Higher scores indicate greater psychological flexibility.
Other outcomes
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.
Sponsors and contacts
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