UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056223 |
|---|---|
| Receipt number | R000064232 |
| Scientific Title | A Randomised Controlled Trial of Compassionate Mind Training for Gay People |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/21 10:21:08 |
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Basic information
Public title
A Randomised Controlled Trial of Compassionate Mind Training for Gay People
Acronym
CMT-Gay
Scientific Title
A Randomised Controlled Trial of Compassionate Mind Training for Gay People
Scientific Title:Acronym
CMT-Gay
Region
| Asia(except Japan) |
Condition
Condition
Psychological Distress in Gay Individuals
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Compassionate Mind Training (CMT) in reducing psychological distress among gay adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological distress, as measured by the total score of the Depression, Anxiety, and Stress Scale (DASS-21), at baseline, post-intervention, and 1-month follow-up.
Key secondary outcomes
Self-compassion, measured by the Compassionate Engagement and Actions Scale (CEAS), fear of compassion, measured by the Fears of Compassion Scale (FCS), and self-criticism, measured by the Forms of Self-Criticism and Self-Reassurance Scale (FSCSR), all assessed at baseline, post-intervention, and 1-month follow-up. Positive and negative affect, measured by the Scale of Positive and Negative Experience (SPANE), and suicidality, measured by the Suicidal Ideation Attributes Scale (SIDAS). Sexual risk behaviors, including frequency of condom use, engagement in sexual activity, and use of pre-exposure prophylaxis (PrEP), reported at baseline and follow-up. Demographics such as age, education, income, level of involvement in the LGB community, outness, and gender expression. Sexual minority stressors, including internalized homonegativity, measured by the Internalized Homonegativity Inventory (IHNI), rejection sensitivity, measured by the Gay-Related Rejection Sensitivity Scale (GRS), and perceived discrimination, measured by the Heterosexist Harassment, Rejection, and Discrimination Scale (HHRDS), all assessed at baseline, post-intervention, and 1-month follow-up. Feasibility measured by participant satisfaction, adherence, and completion of the program. Embodiment of compassion, measured by the Embodiment Scale, assessed at baseline, post-intervention, and 1-month follow-up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants attend a 150-minute seminar on Day 1, which includes psychoeducation and compassion skills training. They engage in 30 days of daily audio-guided practices. Participants also receive a 15-20 minute phone consultation on Day 15 to 20.
Interventions/Control_2
Participants receive no intervention during the study period. They will be offered the option to attend the seminar after the study is completed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
- Be 18 years or older.
- Self-identify as a cisgender gay man.
- Be fluent in Chinese.
Key exclusion criteria
- Do not meet the inclusion criteria.
- Are unable to provide informed consent.
Target sample size
158
Research contact person
Name of lead principal investigator
| 1st name | Ching Kwong |
| Middle name | |
| Last name | Wong |
Organization
The University of Hong Kong
Division name
Department of Psychology
Zip code
Nil
Address
Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong
TEL
85239177122
dinockw@connect.hku.hk
Public contact
Name of contact person
| 1st name | Ching Kwong |
| Middle name | |
| Last name | Wong |
Organization
The University of Hong Kong
Division name
Department of Psychology
Zip code
Nil
Address
Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road,
TEL
85239177122
Homepage URL
dinockw@connect.hku.hk
Sponsor or person
Institute
Department of Psychology, The University of Hong Kong
Institute
Department
Personal name
Wong Ching Kwong
Funding Source
Organization
Self-financed
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
China (Hong Kong)
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Departmental Research Ethics Committee, Department of Psychology, The University of Hong Kong
Address
Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong
Tel
85239177122
dpsychol@hku.hk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
The University of Hong Kong (Hong Kong)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
182
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
Yes
IPD sharing Plan description
Data will include baseline demographics, outcome measures, and intervention adherence, with all personal identifiers removed. Access will be open to qualified researchers upon request."
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064232
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