Feasibility, Acceptability, and Preliminary Effects of an Acceptance and Commitment Therapy-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Perinatal Grief
研究概览
简要总结
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. Online sessions occur within 3 days, at 2 weeks, at 1 month, and at 3 months after discharge; the final session is a booster. 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 18-item satisfaction questionnaire at T1 and are invited to qualitative interviews within 1 week after intervention completion.
详细描述
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 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older.
- •Diagnosed as requiring induction of labour because of fetal or maternal health problems.
- •A spouse willing to participate in the intervention as the primary caregiver.
- •Ability to use a smartphone, tablet, or computer to complete the online psychological intervention and questionnaires.
- •Provision of written informed consent.
排除标准
- •Life-threatening severe complications, including heart failure, eclampsia, severe pre-eclampsia, or major haemorrhage.
- •A diagnosed psychological or psychiatric illness, or evident self-harm or suicidal tendencies or behaviour.
- •Current participation in a related support intervention or participation in such an intervention within the preceding 30 days.
- •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
研究组 & 干预措施
intervention group
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.
干预措施: Acceptance and Commitment Therapy (Behavioral)
Control group
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.
结局指标
主要结局
Perinatal Grief
时间窗: Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention)
Measured by the 15-item Perinatal Grief Scale Short Form (15-PGS-SF; Li et al., 2025). Higher scores indicate more severe grief symptoms.
次要结局
- Depressive Symptoms(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention))
- Anxiety Symptoms(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention))
- Post-Traumatic Stress Symptoms(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention))
- Psychological Flexibility(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention))
- Perceived Social Support(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention))
- Health Information Literacy(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention).)
- Self-Care(Baseline (T0, before randomisation) and immediately post-intervention (T1, within 1 week after completion of intervention).)
研究者
Liyang
Head Nurse of the Department
Second Xiangya Hospital of Central South University