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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034913
Receipt No. R000039805
Official scientific title of the study 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

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Basic information
Official scientific title of the study Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial
Title of the study (Brief title) 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 Dr Bernedeth Ezegbe
Organization University of Nigeria Nsukka
Division name Department of Social Science Education
Address Harden Building, Department of Social Science Education, University of Nigeria Nsukka
TEL +2348035847979
Email bernedeth.ezegbe@unn.edu.ng

Public contact
Name of contact person Chiedu Eseadi
Organization University of Nigeria Nsukka
Division name Department of Educational Foundations
Address Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka
TEL +2348137258914
Homepage URL
Email chiedu.eseadi@unn.edu.ng

Sponsor
Institute Otusum Consult Training & Services
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 03 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039805

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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