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NCT Number: NCT07077759

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Postpartum Depression (PPD) Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Metropolitan University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Online self-compassion intervention

Other

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.

Primary outcomes

  1. Paternal perinatal depression

    Time frame: 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).

  2. Anxiety

    Time frame: 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.

Secondary outcomes

  1. Emotion regulation

    Time frame: From enrollment to the end of treatment at 2 months

    Emotion regulation will be measured by the 10-item Emotion Regulation Questionnaire (ERQ). It includes two subscales: Cognitive reappraisal and expressive suppression. Items are rated on a 7-point scale (1=Strongly Disagree to 7=Strongly Agree). The total score for cognitive reappraisal ranges from 0 to 42, and the total score for expressive supression ranged from 0 to 28. Higher scores mean more frequent use of that strategy.The Cronbach's alpha was 0.82 and 0.77 for cognitive reappraisal and suppression, respectively.

  2. Self-compassion

    Time frame: From enrollment to the end of intervention at 2 months

    Self-compassion will be measured using the 12-item short version of the self-compassion scale (SCS). Items are rated on a 5-point Likert scale ranging from 1 (Almost Never) to 5 (Almost Always). The total score ranged from 12 to 60, with higher score indicating higher level of self-compassion. The scale has demonstrated good internal consistency in Chinese sexual minorities (Cronbach's alpha = 0.87)

  3. Resilience

    Time frame: From enrollment to the end of treatment at 2 months.

    Resilience will be measured by the six-item brief resilience scale (BRS). Items are rated on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score ranges from 6 to 30, with higher score indicating higher level of resilience.

  4. insomnia

    Time frame: From enrollment to the end of treatment at 2 months.

    Insomnia will be measured using the 7-item Insomnia Severity Index (ISI). Items are measured on five point likert scale (0-4). The total score of 0-28, with higher scores meaning worse insomnia.

  5. Parent sense of competency

    Time frame: From enrollment to the end of treatment at 2 months.

    Participant's sense of parent competency will be measured using the 17-item Parent Sense of Competency Scale (PSOC). Items are rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". The total score ranged from 17 to 102, with higher score indicating high level of parent competency.

  6. Parental stress

    Time frame: From enrollment to the end of treatment at 2 months.

    Parental stress will be measured using the 17-item of the Chinese version of Parental Stress Scale (PSS). Items are raged on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). The total score ranges from 17 to 102, with higher score indicating higher level of parental stress.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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