An Online Self-compassion Intervention for Anxiety and Depression in Fathers of Infants: A Feasibility Study
1 other identifier
interventional
40
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
ExpectedApril 27, 2026
April 1, 2026
4 months
July 12, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Paternal perinatal depression
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).
From enrollment to the end of treatment at 2 months.
Anxiety
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.
From enrollment to the end of treatment at 2 months.
Secondary Outcomes (6)
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.
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.
- +1 more secondary outcomes
Study Arms (2)
Online self-compassion intervention
EXPERIMENTALParticipants in the self-compassion group will receive five consecutive weekly sessions intervention.
Control group
NO INTERVENTIONParticipants in the waiting-list control group will receive the same training after the completion of the intervention at a 2-month follow-up.
Interventions
Participants in the intervention group will receive five consecutive weekly sessions, with each session lasting 2 hours (totaling 10 hours). Each session will include an introduction, guided exercises, group discussions and home practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- currently experiencing psychosis
- having an intellectual disability
- experiencing current suicidal ideation
- participation in a similar study or received similar services in the past year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong Kong Metropolitan University
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 12, 2025
First Posted
July 22, 2025
Study Start
October 1, 2025
Primary Completion
January 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share