Pilot RCT Tests ACT for Perinatal Loss Mental Health
ClinicalTrials.gov Studies
Summary
NIH registered a pilot randomized controlled trial (NCT07538011) evaluating an Acceptance and Commitment Therapy-based psychosocial intervention for women who have experienced perinatal loss. The 4-week mixed-format program includes four in-person sessions and two videoconferencing sessions, with a 30-minute booster one month post-completion. The study will assess feasibility, acceptability, and preliminary effects on perinatal grief, PTSD, depression, anxiety, psychological flexibility, and social support.
What changed
NIH registered a new clinical trial (NCT07538011) on ClinicalTrials.gov — a pilot randomized controlled trial testing Acceptance and Commitment Therapy for women with perinatal loss. The study employs a mixed-format 4-week intervention with in-person hospital sessions and post-discharge videoconferencing, assessing feasibility, acceptability, and preliminary effectiveness across multiple mental health outcomes.
Healthcare providers and clinical investigators involved in perinatal mental health research should note this trial as an emerging evidence source. Results may inform future intervention design for this patient population, though the pilot study itself is not a regulatory action.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effects of a Acceptance and Commitment Therapy-Based Psychosocial Intervention on Mental Health of Women With Perinatal Loss: A Pilot Randomised Controlled Trial
N/A NCT07538011 Kind: NA Apr 20, 2026
Abstract
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.
Conditions: ACT, Perinatal Loss, Mental Health
Interventions: Acceptance and Commitment Therapy
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.