UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052540 |
|---|---|
| Receipt number | R000059798 |
| Scientific Title | Efficacy of mh-GAP in Redacting Stigma and Discrimination among University Students of Swat (KPK): A randomized Control trial |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2023/10/18 22:23:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of mh-GAP in Redacting Stigma and Discrimination among University Students of Swat (KPK): A randomized Control trial
Acronym
MH-GAP, Stigma, Disc, RCT
Scientific Title
Efficacy of mh-GAP in Redacting Stigma and Discrimination among University Students of Swat (KPK): A randomized Control trial
Scientific Title:Acronym
MH-GAP, Stigma, Disc, RCT
Region
| Asia(except Japan) |
Condition
Condition
MH GAP intervention's Depression module will be utilised to lessen stigma and discrimination among participants.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To assess the efficacy of mhGap in reducing stigma and discrimination among university students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The meaurement scale would be :
-To assess the efficacy of mhGap in reducing stigma and discrimination among university student
-MH Gap, depression module
-Mental Health Knowledge Schedule
-The Discrimination and Stigma Scale (DISC 12)
-Internalized Stigma of Mental Illness Inventory
this outcome will be meaured with in six months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eperimental grup will recive depression module through mh-gap, this group will recive depression module in 5 sessions.each session will be approximatly 50 minutes each.
Interventions/Control_2
control group will recive treatment as usual.
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
| 28 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students having major in any discipline other than psychology will be included
Students having family members or relatives having mental disorder will also excluded.
Students who are living in hostels or day scholars will also be included.
Key exclusion criteria
Students with diagnosed psychiatric illness will be excluded.
Students already receiving any intervention for mental disorders will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Dr.Ayesha |
| Middle name | |
| Last name | Aziz |
Organization
Department of professional psychology bahria university, lahore
Division name
Lahore, Punjab, Pakistan
Zip code
54782
Address
47-C Civic Center, Johar Town, Block D, Lahore
TEL
0321-7030921
ayesha.bulc@bahria.edu.pk
Public contact
Name of contact person
| 1st name | Naveed |
| Middle name | Ahmad |
| Last name | khan |
Organization
Department of professional psychology bahria university, lahore
Division name
Lahore, Punjab, Pakistan
Zip code
54782
Address
47-C Civic Center, Johar Town, Block D, Lahore
TEL
0333-4767148
Homepage URL
naveed.bulc@bahria.edu.pk
Sponsor or person
Institute
Department of professional psychology bahria university, lahore
Institute
Department
Personal name
Dr.Ayesha Aziz
Funding Source
Organization
non funded research
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
pakistan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of professional psychology bahria university, lahore
Address
47-C Civic Center, Johar Town, Block D, Lahore
Tel
04299233408
khawer.bulc@bahria.edu.pk
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 23 | 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
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
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059798
