UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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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