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

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

Treatments tested in this trial

  • Acceptance and Commitment Therapy

Treatment groups

88 Participants
are divided into 2 treatment groups