An interventional study of Acceptance and Commitment Therapy in ACT, Perinatal Loss and Mental Health, sponsored by Second Xiangya Hospital of Central South University. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Second Xiangya Hospital of Central South University · Not applicable, Interventional, and Supportive care
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.
Background The intervention is informed by the transactional model of stress and cognitive appraisal and the findings of the research programme. It combines perinatal loss health education, ACT-based psychological support, rehabilitation activities including mindful yoga, and family social support. ACT addresses acceptance, cognitive defusion, contact with the present moment, self-as-context, values clarification, and committed action.
Before pilot testing, intervention content was reviewed through two to three rounds of Delphi consultation with eight experts: two psychology experts, three obstetricians, and three obstetric nurses. Each expert had more than 10 years of experience and a senior professional title. Relevance, clarity, readability, and appropriateness were rated on a 4-point scale. Two women with previous perinatal loss and education no higher than high school also reviewed comprehensibility and relevance to their needs. All final expert item ratings were at least 3, and minor revisions informed the pilot intervention.
Intervention This study tests a 3-month ACT-based psychosocial intervention delivered across eight sessions (45-60 minutes each). 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 5-7: Remote via Tencent Meeting (videoconferencing), one-on-two format, covering the post-discharge physical and emotional recovery period.
Booster session (session 8): 30-minute remote session three month after discharge.
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 two-arm, assessor-masked, parallel-group pilot randomised controlled trial conducted at three tertiary hospitals in Changsha, Hunan, China. Woman-spouse dyads are allocated in a 1:1 ratio to usual care plus the family psychosocial intervention or usual care alone. Block randomisation uses a block size of four. An independent research assistant, a registered nurse with a bachelor's degree in nursing, generates the allocation sequence using an online randomisation programme and is not involved in recruitment, intervention delivery, or outcome analysis.
Allocation is concealed using sequentially numbered, sealed, opaque envelopes prepared by the research assistant and delivered to participants by the project manager. Outcome assessment uses online questionnaires, with participant identifiers and allocation coded before analysis to support assessor masking. Process evaluation and a descriptive qualitative component inform refinement of the intervention.
Participants, Sample Size, and Recruitment The target sample is 44 woman-spouse dyads, with 22 dyads per arm. The sample-size rationale uses a pilot-study minimum of 30 and an anticipated attrition rate of 32% from the preceding systematic review and meta-analysis. This is a pilot sample intended to evaluate feasibility, acceptability, and preliminary effects.
Convenience sampling is used. After ethics approval at each hospital, midwives distribute recruitment information through hospital online platforms and posters. Interested women undergo eligibility screening through the responsible midwife and meet a research assistant to discuss the study purpose, procedures, benefits, risks, and the right to withdraw before providing written informed consent.
Outcome Measures
Quantitative measures:
Feasibility is assessed through eligibility and consent rates, reasons for declining participation, adherence, intervention implementation, attrition, and reasons for withdrawal. Intervention completion is defined as attending at least six of the eight sessions (at least 75%).
Acceptability is assessed in the intervention group using an 17-item study-specific satisfaction questionnaire adapted from the 15-item Chinese Standardized Client Satisfaction Scale and qualitative interviews at T1. Each woman and her spouse complete the satisfaction questionnaire jointly.
The primary preliminary-effectiveness outcome is perinatal grief, measured using the Perinatal Grief Scale (PGS-15). Secondary outcomes for women are depressive symptoms (PHQ-9), anxiety symptoms (GAD-7), post-traumatic stress symptoms (IES-R), psychological flexibility (Psy-Flex-C), health information literacy (HILS), mindful self-care (B-MSCS), and Multidimensional Scale of perceived social support (MSPSS).
Qualitative component:
All women and spouses in the intervention group (target: 22 dyads) are invited to semi-structured interviews within 1 week after intervention completion (T1). Trained research assistants conduct the interviews through Tencent Meeting to explore experiences, perceived facilitators, barriers, and benefits. Interviews are digitally audio-recorded with consent using an iFlytek SR701 recorder.
The first author transcribes the recordings verbatim and a research assistant checks the transcripts. Content analysis is conducted with NVivo following Bengtsson's four stages: decontextualisation, recontextualisation, categorisation, and compilation.
Assessment Schedule Baseline data (T0), including demographics and primary and secondary outcomes, are collected online with research-assistant support before randomisation. Post-intervention assessment (T1) occurs within 1 week after completion of the approximately 3-month intervention, including the final booster session. The intervention group completes primary and secondary outcome questionnaires and the satisfaction questionnaire and is invited to qualitative interviews during this week. The control group completes only the primary and secondary outcome questionnaires over the corresponding time interval.
Data Management and Quality Control Data are collected through Questionnaire Star (WJX). Records use study identification codes and are password-protected. Paper records are stored in locked cabinets; electronic records are stored on password-protected USB drives with password-protected cloud backup accessible only to the research team. Records are retained for 6 years and then destroyed. Audio recording requires participant consent.
Participation is voluntary, written informed consent is obtained, and participants may pause or withdraw without penalty. If self-harm or suicidal tendencies are reported or identified, the research assistant informs the principal investigator, who facilitates access to medical support and, with participant consent, informs the emergency contact. Intervention contacts include physical and psychological risk review and referral as required.
Data Analysis Quantitative data are analysed using R with a significance level of 0.05. Descriptive statistics summarise demographic and clinical characteristics, implementation measures, and outcome scores. Distributional characteristics are examined using skewness, kurtosis, normality tests, histograms, and Q-Q plots. Baseline continuous variables are compared using independent-samples t tests or Mann-Whitney U tests as appropriate; categorical variables are compared using continuity-corrected chi-square tests or Fisher's exact tests.
For non-normally distributed outcome data, within-group changes from T0 to T1 are examined using Wilcoxon signed-rank tests and between-group comparisons use Mann-Whitney U tests. Between-group effect sizes at T1 are estimated using Hedges' g.
Qualitative data are analysed with NVivo using Bengtsson's content-analysis stages of decontextualisation, recontextualisation, categorisation, and compilation. Recordings are transcribed verbatim by the first author and checked by a research assistant.
Study Objectives The pilot evaluates whether the family psychosocial intervention can be delivered as planned, its acceptability to women and their spouses, and preliminary differences between the intervention and usual-care groups in changes in perinatal grief and secondary outcomes from T0 to T1. Feasibility and acceptability findings will inform intervention refinement. Intervention completion is defined as attendance at six or more of the eight sessions.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's enrollment of 88 is below the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Second Xiangya Hospital of Central South University is the lead sponsor of 82 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Women and their spouses receive routine ward care plus an approximately 3-month, eight-session ACT-based family psychosocial intervention. Four inpatient face-to-face sessions (30-60 minutes each) are followed by four online dyadic sessions via Tencent Meeting (20-45 minutes each), within 3 days, at 2 weeks, at 1 month, and at 3 months after discharge. The final session is a booster included in the eight-session total. Each session involves one interventionist with the woman and her spouse. The programme combines health education, ACT-based grief and emotion management, rehabilitation, and family social support, supported by a workbook and home-practice videos.
Behavioral: Acceptance and Commitment Therapy
Women and their spouses receive routine care provided by their hospital ward, including admission assessment, basic nursing care, medication instructions, precautions following induction of labour, discharge guidance, and information about follow-up appointments. No additional study-specific family psychosocial intervention is provided.
Session Outline Session 1: Diagnostic clarification and emotional stabilisation on admission; 45-60 minutes. Session 2: Preparation for induction and trauma stabilisation after the treatment plan is agreed and before induction; 45-60 minutes. Session 3: Acknowledgement of grief and voluntary remembrance within 24-48 hours after induction, adjusted to physical condition; 30-60 minutes. Session 4: Rehabilitation, self-care, and a family support plan on the day before discharge or the discharge day; within the 30-60-minute inpatient-session range. Session 5: Post-discharge physical and psychological safety review and continuity of support within 3 days after discharge; 20-30 minutes. Session 6: Values clarification and anxiety management at 2 weeks after discharge; 30-45 minutes. Session 7: Consolidation of self-care and connection to clinical, community, and peer resources at 1 month after discharge; 20-30 minutes. Session 8: Booster focusing on anxiety, future pregnancy concerns.
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.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Depressive Symptoms
Measured by the Patient Health Questionnaire-9 (PHQ-9; Wang et al., 2014). Higher scores indicate more severe depressive symptoms.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Anxiety Symptoms
Measured by the Generalized Anxiety Disorder-7 (GAD-7; Zeng et al., 2013). Higher scores indicate more severe anxiety symptoms.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
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.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Psychological Flexibility
Measured by the Psy-Flex-C (Li et al., 2024a). Higher scores indicate greater psychological flexibility.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Perceived Social Support
Measured by the Multidimensional Scale of Perceived Social Support Scale (MSPSS; Yang, 2024). Higher scores indicate greater perceived social support.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Health Information Literacy
Measured by the Health Information Literacy Self-rating Scale.
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention).
Self-Care
Measured by the Mindful Self-Care Scale - Brief (B-MSCS).
Time frame: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention).
Intervention Satisfaction
Measured by an adapted 17-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.
Time frame: Immediately post-intervention (T1, within 1 week after completion of intervention)
Feasibility and Acceptability
Feasibility is assessed through eligibility and consent rates, reasons for declining participation, adherence, intervention implementation, attrition, and reasons for withdrawal. Intervention completion is defined as attending at least six of the eight sessions (at least 75%). Acceptability is assessed in the intervention group using an 18-item study-specific satisfaction questionnaire adapted from the 15-item Chinese Standardized Client Satisfaction Scale and qualitative interviews at T1. Each woman and her spouse complete the satisfaction questionnaire jointly. Items use a 5-point Likert response scale from 1 (very dissatisfied) to 5 (very satisfied); higher scores indicate greater satisfaction.
Time frame: Immediately post-intervention (T1, within 1 week after completion of intervention)
Plan to share: No — Considering ethical reasons and participant privacy, we will not make individual participant data publicly available.
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Second Xiangya Hospital of Central South University