UMIN-CTR 臨床試験登録情報の閲覧

Recruitment status Completed
Unique ID issued by UMIN UMIN000038915
Receipt No. R000044370
Scientific Title cognitive behavioural intervention
Date of disclosure of the study information 2019/12/17
Last modified on 2019/12/17 (Ver. 1)

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Basic information
Public title Effect of Cognitive Behavioral Intervention on Depression Reduction among Community-dwelling Adult Learners in Nigeria: Implications for Adult Education Administration
Acronym ECBI
Scientific Title cognitive behavioural intervention
Scientific Title:Acronym CBI
Region
Africa

Condition
Condition Randomised
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Explorative
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The itAfter a 10-weeks participation in CBI, the assessment results showed significant reduction in depression ervention reduced depression
Key secondary outcomes The follow-up assessment indicated a further significant reduction in the depression level

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 YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 10 weeks intervention
Interventions/Control_2 10 weeks of no treatment
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
65 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria included having depression; being a l university adult learner that dwells in a community within the Abia state region of Nigeria; not being currently in any depression intervention or psychotherapy; being willing to sign informed consent to participate in the study; not having the presence of bipolar or psychotic subtypes of depression, panic disorder, current substance abuse, past or present schizophrenia, organic brain syndrome, being currently in educational intervention, psychotherapy, psychotropic medication or hospitalization for psychosis or risk of imminent suicide
Key exclusion criteria Opposite of inclusion criteria
Target sample size 220

Research contact person
Name of lead principal investigator
1st name Linus
Middle name Okechukwu
Last name Nwabuko
Organization UNN
Division name UNN
Zip code 410001
Address Adult Education
TEL +23480......
Email counsellorotu@gmail.com

Public contact
Name of contact person
1st name C
Middle name
Last name Eze
Organization UNN
Division name UNN
Zip code 410001
Address Adult Education University Of Nigeria, Nsukka
TEL +2345
Homepage URL
Email counsellorotu@gmail.com

Sponsor
Institute UNN
Institute
Department

Funding Source
Organization The authors
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Nigeria

Other related organizations
Co-sponsor N/A
Name of secondary funder(s) N/A

IRB Contact (For public release)
Organization UNN
Address Institute Of Education, University Of Nigeria, Nsukka
Tel +234
Email counsellorotu@gmail.com

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
2019 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications Effective
Number of participants that the trial has enrolled 220
Results 
The initial assessment results showed that the participants in both treatment and usual-care control groups had severe depression.
Results date posted
2019 Year 12 Month 17 Day
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
2019 Year 05 Month 03 Day
Date of IRB
2019 Year 05 Month 18 Day
Anticipated trial start date
2019 Year 06 Month 18 Day
Last follow-up date
2019 Year 09 Month 19 Day
Date of closure to data entry
2019 Year 10 Month 26 Day
Date trial data considered complete
2019 Year 10 Month 30 Day
Date analysis concluded
2019 Year 11 Month 01 Day

Other
Other related information N/A

Management information
Registered date
2019 Year 12 Month 17 Day
Last modified on
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044370