UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034163
Receipt number R000038949
Scientific Title Effect of group cognitive behavioral therapy on depressive symptoms in a sample of college adolescents in Nigeria
Date of disclosure of the study information 2018/09/15
Last modified on 2018/09/15 20:25:29

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Basic information

Public title

Effect of group cognitive behavioral therapy on depressive symptoms in a sample of college adolescents in Nigeria

Acronym

Effect of group CBT on depressive symptoms

Scientific Title

Effect of group cognitive behavioral therapy on depressive symptoms in a sample of college adolescents in Nigeria

Scientific Title:Acronym

Effect of group CBT on depressive symptoms

Region

Africa


Condition

Condition

Depressed college adolescents

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of group cognitive behavioral therapy on depressive symptoms of college adolescents in Nigeria

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Centre for Studies Depression Scale for Children (CES-DC): Time 1, Time 2, Time 3

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Intervention group

Duration: 12 sessions

Interventions/Control_2

Wait-list control group

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

16 years-old <=

Age-upper limit

21 years-old >=

Gender

Male and Female

Key inclusion criteria

moderate to severe depression, clinical depression at baseline, 15years and above, mobile phone ownership for communication, availability to participate

Key exclusion criteria

Not meeting inclusion criteria

Target sample size

162


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ede O. Moses

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

07066725165

Email

moses.ede@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

08137258914

Homepage URL


Email

chiedu.eseadi@unn.edu.ng


Sponsor or person

Institute

Otusum Consult Training & Services, Uyo, Nigeria

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Nigeria


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 09 Month 15 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

2017 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 15 Day

Last modified on

2018 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038949


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name