NCT07077759

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress65%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

July 12, 2025

Last Update Submit

April 24, 2026

Conditions

Keywords

Paternal perinatal depressionfatherself-compassion

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

EXPERIMENTAL

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

Other: Online self-compassion intervention

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.

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.

Online self-compassion intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: non-RCT with a waiting-list control group
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

Locations