跳至主要内容
临床试验/NCT07077759
NCT07077759进行中(未招募)不适用

An Online Self-compassion Intervention for Anxiety and Depression in Fathers of Infants: A Feasibility Study

Hong Kong Metropolitan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Anxiety

研究概览

简要总结

To investigate the feasibility, acceptability, and preliminary effectiveness of an online mindfulness and self-compassion intervention for the mental health in fathers experiencing paternal perinatal depression (PPD).

详细描述

The pilot non-RCT will be assessed using an online survey and semi-structured individual interviews. Preliminary effectiveness measures include self-compassion, emotion regulation, resilience, parenting sense of competence, parental stress, marital satisfaction, insomnia, generalized anxiety, and PPD measured at baseline, immediate post-intervention, and 2-month follow-up. Mixed-effects models will test changes between groups, while directed content analysis will be employed for qualitative data.

研究设计

研究类型
Interventional
分配方式
Non 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
Male
接受健康志愿者
是

入选标准

  • •aged 18 years or above
  • •the biological father who is expecting or the biological father of infants within 24 months old
  • •experienced mild to moderate anxiety (5 ≤ GAD ≤14) or depression symptoms (5≤ PHQ ≤ 19)
  • •sufficient comprehension of Cantonese
  • •currently live in Hong Kong
  • •able to provide informed consent

排除标准

  • •currently experiencing psychosis
  • •having an intellectual disability
  • •experiencing current suicidal ideation
  • •participation in a similar study or received similar services in the past year

研究组 & 干预措施

Online self-compassion intervention

Experimental

Participants in the self-compassion group will receive five consecutive weekly sessions intervention.

干预措施: Online self-compassion intervention (Other)

Control group

No Intervention

Participants in the waiting-list control group will receive the same training after the completion of the intervention at a 2-month follow-up.

结局指标

主要结局

Anxiety

时间窗: From enrollment to the end of treatment at 2 months.

Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder-7 (GAD-7). Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher total scores indicating higher levels of anxiety symptoms.

Paternal perinatal depression

时间窗: From enrollment to the end of treatment at 2 months.

Paternal perinatal depression will be measured using the Chinese version of the 9-item Patient Health Questionnaire (PHQ-9). Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher total scores indicating higher levels of depressive symptoms. The scale is reliable in the Chinese population (Cronbach's α = 0.82).

次要结局

  • insomnia(From enrollment to the end of treatment at 2 months.)
  • Parent sense of competency(From enrollment to the end of treatment at 2 months.)
  • Parental stress(From enrollment to the end of treatment at 2 months.)
  • Emotion regulation(From enrollment to the end of treatment at 2 months)
  • Self-compassion(From enrollment to the end of intervention at 2 months)
  • Resilience(From enrollment to the end of treatment at 2 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Polly MA Haixia

Assistant Professor

Hong Kong Metropolitan University

研究点 (1)

Loading locations...

相似试验

An Online Self-compassion Intervention for Anxiety... | 临床试验