UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038915 |
|---|---|
| Receipt number | R000044370 |
| Scientific Title | cognitive behavioural intervention |
| Date of disclosure of the study information | 2019/12/17 |
| Last modified on | 2019/12/17 18:30:51 |
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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......
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
counsellorotu@gmail.com
Sponsor or person
Institute
UNN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044370
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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