UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034913 |
|---|---|
| Receipt number | R000039805 |
| Scientific Title | Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/11/16 |
| Last modified on | 2018/11/16 17:17:18 |
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Basic information
Public title
Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial
Acronym
Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students
Scientific Title
Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial
Scientific Title:Acronym
Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students
Region
| Africa |
Condition
Condition
Anxiety and Depression
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the impacts of cognitive-behavioral intervention on anxiety and depressive symptoms in Nigerian undergraduate social science education students population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
SMGAD-A: Time 1, Time 2, Time 3
Key secondary outcomes
GDS: Time 1, Time 2, Time 3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention, n=28
Treatment session: 120minutes during each meeting
Cognitive-Behavioral Treatment (CBT) for Adults with Generalized Anxiety Disorder Manual
Treatment Manual for Cognitive-Behavioral Therapy for Depression
Interventions/Control_2
Waitlisted control group, n=27
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
| 21 | years-old | <= |
Age-upper limit
| 28 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students with severe anxiety and depressive symptoms were selected as participants. Other set criteria for eligibility involved providing written, informed consent and being readily available for the study. Those participants who met the inclusion criteria were selected.
Key exclusion criteria
The screened participants who did not meet any of these criteria were not invited to participate in the study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr Bernedeth Ezegbe |
Organization
University of Nigeria Nsukka
Division name
Department of Social Science Education
Zip code
Address
Harden Building, Department of Social Science Education, University of Nigeria Nsukka
TEL
+2348035847979
bernedeth.ezegbe@unn.edu.ng
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiedu Eseadi |
Organization
University of Nigeria Nsukka
Division name
Department of Educational Foundations
Zip code
Address
Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka
TEL
+2348137258914
Homepage URL
chiedu.eseadi@unn.edu.ng
Sponsor or person
Institute
Otusum Consult Training & Services
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 11 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039805
