Postpartum Depression (PPD)NCT07077759
An Online Self-compassion Intervention for Anxiety and Depression in Fathers of Infants: A Feasibility Study
A study testing Online self-compassion intervention in people with Postpartum Depression (PPD), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Online self-compassion intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently experiencing psychosis
- having an intellectual disability
- experiencing current suicidal ideation
- participation in a similar study or received similar services in the past year
Trial locations and contacts
1 site in 1 country.
About this 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).
Read the detailed description
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.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- Online self-compassion intervention
- Keywords
- Paternal perinatal depression, father, self-compassion
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-compassion interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Online self-compassion intervention | Experimental | Participants in the self-compassion group will receive five consecutive weekly sessions intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From enrollment to the end of treatment at 2 months.
Secondary outcomes (6)
Emotion regulation
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.
Measured: From enrollment to the end of treatment at 2 months
Self-compassion
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)
Measured: From enrollment to the end of intervention at 2 months
Resilience
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.
Measured: From enrollment to the end of treatment at 2 months.
insomnia
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.
Measured: From enrollment to the end of treatment at 2 months.
Parent sense of competency
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.
Measured: From enrollment to the end of treatment at 2 months.
Parental stress
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.
Measured: From enrollment to the end of treatment at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Oct 2025
- Primary completion31 Jan 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-RCT with a waiting-list control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Polly MA Haixia, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077759
- Sponsor's protocol ID
- HE-RD/2025/1.8
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Self-compassion Intervention for Anxiety and Depression in Fathers of Infants: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07077759
- Acronym / sponsor ID
- HE-RD/2025/1.8
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Paternal perinatal depression, father, self-compassion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- non-RCT with a waiting-list control group
| Arm | Type | Receives |
|---|---|---|
| Online self-compassion intervention | Experimental | Other: Online self-compassion interventionParticipants in the self-compassion group will receive five consecutive weekly sessions 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- currently experiencing psychosis
- having an intellectual disability
- experiencing current suicidal ideation
- participation in a similar study or received similar services in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-compassion interventionParticipants 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. | Other | Online self-compassion intervention |
Primary outcome
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).
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.
6 secondary outcomes
Emotion regulation
Time frame: From enrollment to the end of treatment at 2 months
Self-compassion
Time frame: From enrollment to the end of intervention at 2 months
Resilience
Time frame: From enrollment to the end of treatment at 2 months.
insomnia
Time frame: From enrollment to the end of treatment at 2 months.
Parent sense of competency
Time frame: From enrollment to the end of treatment at 2 months.
Parental stress
Time frame: From enrollment to the end of treatment at 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online self-compassion intervention in people with Postpartum Depression (PPD), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal perinatal depression (time frame: From enrollment to the end of treatment at 2 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.