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.

Background Perinatal loss, including miscarriage, stillbirth, and neonatal death, is a profound traumatic event affecting approximately 15-20% of pregnancies. Women who experience perinatal loss are at elevated risk for prolonged grief disorder, major depressive disorder, post-traumatic stress disorder, and anxiety disorders. Although maternal mental health has gained increasing attention in China, evidence-based, culturally adapted psychosocial interventions for perinatal loss remain scarce. Preliminary surveys by our research team indicate a strong need for grief support among bereaved women, yet healthcare providers (midwives and nurses) lack the knowledge and skills to deliver such support. Acceptance and Commitment Therapy (ACT), a third-wave cognitive behavioural approach, has shown benefits for individuals experiencing grief and trauma by increasing psychological flexibility-an empirically supported process linked to improved mental health and adaptive coping. ACT targets six core processes: acceptance, cognitive defusion, contact with the present moment, self-as-context, values clarification, and committed action. However, prior trials in perinatal loss populations remain limited, and no culturally adapted ACT-based intervention has been evaluated in the Chinese context. Intervention This study tests a 4-week ACT-based psychosocial intervention delivered across six sessions (45-60 minutes each), plus a 30-minute booster session one month after the final session. The intervention integrates four thematic components: (1) perinatal loss health education; (2) ACT-based grief and emotion management (acceptance, defusion, present-moment awareness, values, committed action); (3) postpartum rehabilitation mindfulness yoga; and (4) social support from significant others. Delivery format is mixed to accommodate the inpatient-to-outpatient transition: Sessions 1-4: In-person, hospital setting, one-on-two format (woman plus spouse/significant other), covering the inpatient period (admission, induction procedure, postoperative recovery). Sessions 5-6: Remote via Tencent Meeting (videoconferencing), one-on-one format, covering the post-discharge physical and emotional recovery period. Booster session: 30-minute remote session one month after session 6. Participants receive a workbook containing session summaries and homework assignments. QR codes in the workbook provide access to online instructional videos for home-based mindfulness meditation or mindfulness yoga practice. Study Design This is a single-arm pilot interventional study (pre-experimental design). A waitlist control or parallel control group is not included in this pilot phase; findings will inform the design of a future large-scale randomised controlled trial. Participants and Eligibility Women aged ≥18 years who have experienced perinatal loss (miscarriage, stillbirth, or early neonatal death) within the past 12 months are eligible. Exclusion criteria include current severe menta trial.show_full_description

Inclusion Criteria: * Women aged ≥18 years * Experienced perinatal loss (including miscarriage, stillbirth, or early neonatal death) within the past 12 months * Able to read and communicate in Chinese * Willing and able to provide written informed consent Exclusion Criteria: * 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