Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-30 @ 7:35 PM
Study NCT ID:
NCT07077759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Self-compassion Intervention on Paternal Perinatal Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paternal perinatal depression', 'timeFrame': 'From enrollment to the end of treatment at 2 months.', 'description': "(iv) Paternal perinatal depression will be measured using the Chinese version of the 9-item Patient Health Questionnaire (PHQ-9). The scale is reliable in the Chinese population (Cronbach's α = 0.82)."}], 'secondaryOutcomes': [{'measure': 'Emotion regulation', 'timeFrame': 'From enrollment to the end of treatment at 2 months', 'description': "Emotion regulation will be measured by the 10-item Emotion Regulation Questionnaire. The Cronbach's alpha was 0.82 and 0.77 for cognitive reappraisal and suppression, respectively."}, {'measure': 'Self-compassion', 'timeFrame': 'From enrollment to the end of intervention at 2 months', 'description': "Self-compassion will be measured using the short version of the self-compassion scale (Raes et al., 2011). The scale has demonstrated good internal consistency in Chinese sexual minorities (Cronbach's alpha = 0.87)"}, {'measure': 'Resilience', 'timeFrame': 'From enrollment to the end of treatment at 2 months.', 'description': 'Resilience will be measured by the six-item brief resilience scale (BRS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paternal perinatal depression', 'father', 'self-compassion', 'pilot RCT'], 'conditions': ['Postpartum Depression (PPD)']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The pilot RCT will be assessed using an online survey and semi-structured individual interviews. Preliminary effectiveness measures include self-compassion, emotion regulation, resilience, 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) aged 18 years or above; 2) the biological father who is expecting or the biological father of infants within 12 months old; 3) positive in depressive symptom screening with a PHQ-9 scored 9 or above; 4) sufficient comprehension of Cantonese; 5) currently live in Hong Kong; and 6) able to provide informed consent.\n\nExclusion Criteria:\n\n1\\) currently experiencing psychosis; 2) having an intellectual disability; 3) experiencing current suicidal ideation; 4) participation in a similar study or received similar services in the past year.'}, 'identificationModule': {'nctId': 'NCT07077759', 'briefTitle': 'Online Self-compassion Intervention on Paternal Perinatal Depression', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Metropolitan University'}, 'officialTitle': 'The Effect of an Online Self-compassion Intervention on Paternal Perinatal Depression: a Pilot Study', 'orgStudyIdInfo': {'id': 'HE-RD/2025/1.8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online self-compassion intervention', 'description': 'Participants in the self-compassion group will receive five consecutive weekly sessions intervention.', 'interventionNames': ['Other: Online self-compassion intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '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': [{'name': 'Online self-compassion intervention', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Online self-compassion intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Haixia Ma, PhD', 'role': 'CONTACT', 'email': 'phxma@hkmu.edu.hk', 'phoneExt': '+852 39702990'}], 'facility': 'Hong Kong Metropolitan University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'HAIXIA Ma, PhD', 'role': 'CONTACT', 'email': 'phxma@hkmu.edu.hk', 'phone': '+852 39702990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Polly MA Haixia', 'investigatorAffiliation': 'Hong Kong Metropolitan University'}}}}