Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:45 PM
Study NCT ID:
NCT07369661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Brief Self-compassion Intervention for Body Image, Minority Stress, and Sexual Self-efficacy in Hong Kong Gay Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We will include a self-compassion intervention group and a waiting-list control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-18', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-compassion', 'timeFrame': 'From enrollment to the end of intervention at 1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sexuality-based stigma', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': 'Sexuality-based stigma will be measured by the 10-item Chinese men sex with men (MSM) Stigma Scale. Items are rated on a four-point Likert scale from 1 (never) to 4 (many times). The total score ranges from 10 to 40, with higher score indicating higher level of sexuality-based stigma.'}, {'measure': 'Internalized stigma', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': 'Internalized stigma will be measured with the 5-item revised internalized homophobia scale (IHP-R). Items are measured on a five-point Likert scale between 1 (Strongly Disagree) and 5 (Strongly Agree). The total score ranges from 5 to 25, with higher scores indicate greater internalized stigma.'}, {'measure': 'anxiety', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': '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'}, {'measure': 'self-esteem', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': 'The 10-item Rosenberg Self-Esteem Scale (RSE) will be used to measured self-esteem. Items will be rated on a 4-point Liker scale (1 = Strongly agree, 4 = Strongly disagree). The total score ranges from 10 to 40, with higher score indicating higher level of self-esteem.'}, {'measure': 'body objectification', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': 'Self-objectification will be measured using the Chinese version of the Objectified Body Consciousness Scale (OBCS) - body-surveillance subscale. It consists of eight items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). The total score ranges from 7 to 56, with a higher score indicating a higher level of body surveillance.'}, {'measure': 'sexual self-efficacy', 'timeFrame': 'From enrollment to the end of treatment at 1 month', 'description': "The 14-item Condom Self-Efficacy Scale (CSES) will be used to measurement participants' sexual self-efficacy. Items will be measured on a 5-point Likert scale, ranging from 1 (very unsure) to 5 (very sure). The total score ranging from 14 to 70, with higher scores indicated a higher level of condom use efficacy."}, {'measure': 'Body shame', 'timeFrame': 'From enrollment to the end of intervention at 1 month', 'description': 'Body shame will be measured using the Chinese version of the Objectified Body Consciousness Scale (OBCS) - body shame subscale (McKinley \\& Hyde, 1996). It consists of six items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with a higher score indicating a higher level of body shame.'}, {'measure': 'Depression', 'timeFrame': 'From enrollment to the end of intervention at 1 month', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gay men', 'self-compassion', 'body image', 'mental health'], 'conditions': ['Gay Men']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to explore the feasibility, acceptability, and preliminary effectiveness of a brief self-compassion writing intervention on body image, minority stress, and sexual self-efficacy among gay men in Hong Kong.', 'detailedDescription': 'Gay men experience greater body dissatisfaction, a stronger drive for muscularity, and heightened body image concerns compared to their heterosexual counterparts. These issues contribute to minority stress, anxiety, low self-esteem, and engagement in risky sexual behaviors. Using a randomized controlled trial (RCT) design, we aim to explore the feasibility, acceptability, and preliminary effectiveness of a brief self-compassion writing intervention on body image, minority stress, and sexual self-efficacy among gay men in Hong Kong.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study focuses on gay men.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or above\n* self-identified as a gay man\n* sufficient comprehension of Cantonese\n* currently living in Hong Kong\n* able to provide informed consent\n\nExclusion Criteria:\n\n* currently experiencing psychosis\n* having an intellectual disability\n* experiencing current suicidal ideation\n* not currently receiving or engaging in regular mental health services in the last 3 months\n* participation in a similar study or receiving similar services in the past 12 months'}, 'identificationModule': {'nctId': 'NCT07369661', 'briefTitle': 'A Brief Self-compassion Intervention for Body Image, Minority Stress, and Sexual Self-efficacy in Hong Kong Gay Men', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Metropolitan University'}, 'officialTitle': 'A Brief Self-compassion Intervention for Body Image, Minority Stress, and Sexual Self-efficacy in Hong Kong Gay Men', 'orgStudyIdInfo': {'id': 'HE-NHS2025/05'}, 'secondaryIdInfos': [{'id': 'M2025/06', 'type': 'OTHER_GRANT', 'domain': 'Hong Kong Metropolitan University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-compassion interventional group', 'description': 'Interventional group will include 2.5 hour training and 3 weeks self-compassion writing exercise', 'interventionNames': ['Behavioral: Brief self-compassion intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list control group', 'description': 'Waiting-list control group'}], 'interventions': [{'name': 'Brief self-compassion intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will be randomly allocated to the self-compassion group and the waiting list control group. The interveintion group will receive a 2.5 self-compassion training, and 3 week self-compassion writing exercise.', 'armGroupLabels': ['Self-compassion interventional group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', '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', 'phoneExt': '2990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}