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An ACT-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 7 entries Study description shortened, about 125 words Show 1 more changeShow less
    • Study description shortened, about 125 words
  2. Eligibility criteria shortened, about 56 words Study description expanded, about 10 words Show 1 more changeShow less
    • Study description expanded, about 10 words
  3. Completed without a posted recruiting period Primary completion date changed from estimate of Jun 30, 2027 to Aug 30, 2026 · Study sites: 1 to 3 · Start date changed from estimate of Jun 1, 2026 to Apr 10, 2026 · 4 more Show 7 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2027 to Aug 30, 2026
    • Study sites: 1 to 3
    • Start date changed from estimate of Jun 1, 2026 to Apr 10, 2026
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: 5 to 7
    • Study description expanded, about 431 words
    • Study title shortened, about 4 words
  4. Primary and study completion pushed from Dec 31, 2026 to Jun 30, 2027 Enrollment increased: 44 → 88 participants · Start date: May 1, 2026 to Jun 1, 2026 · Eligibility criteria expanded, about 8 wordsv2 Show 3 more changesShow less
    • Enrollment increased: 44 → 88 participants
    • Start date: May 1, 2026 to Jun 1, 2026
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This pilot randomised controlled trial evaluates the feasibility, acceptability, and preliminary effects of an Acceptance and Commitment Therapy (ACT)-based family psychosocial intervention for women requiring medically indicated induction of labour because of fetal or maternal health problems, together with their spouses as primary caregivers. The study is conducted at three tertiary hospitals in Changsha, Hunan, China. The target sample is 44 woman-spouse dyads, allocated 1:1 to usual care plus the intervention or usual care alone. The approximately 3-month intervention comprises eight sessions: four face-to-face hospital sessions lasting 30-60 minutes and four online dyadic sessions via Tencent Meeting lasting 20-45 minutes. The post-discharge online sessions (Sessions 5 to 8) are conducted within 3 days, in the second week, in the first month, and in the third month (booster session) following the patient's discharge. Outcomes are assessed at baseline before randomisation (T0) and within 1 week after intervention completion (T1), with corresponding assessment timing in the control group. Perinatal grief is the primary effectiveness outcome. Secondary outcomes include depression, anxiety, post-traumatic stress symptoms, psychological flexibility, health information literacy, mindful self-care, and perceived social support. Feasibility is assessed through recruitment, adherence, implementation, attrition, and reasons for withdrawal. Intervention-group dyads jointly complete an 17-item satisfaction questionnaire at T1 and are invited to qualitative interviews within 1 week after intervention completion.
Trial Details
NCT Number NCT07538011
Lead Sponsor Second Xiangya Hospital of Central South University
Conditions ACT, Perinatal Loss, Mental Health
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov