UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043019 |
|---|---|
| Receipt number | R000046849 |
| Scientific Title | Effect of rational emotive behaviour therapy programme on post traumatic depression of flood victims in Kogi state, Nigeria |
| Date of disclosure of the study information | 2021/01/16 |
| Last modified on | 2021/01/15 15:49:58 |
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Basic information
Public title
Effect of rational emotive behaviour therapy programme on post traumatic depression of flood victims in Kogi state, Nigeria
Acronym
Rational emotive behaviour therapy programme for post traumatic depression of flood victims
Scientific Title
Effect of rational emotive behaviour therapy programme on post traumatic depression of flood victims in Kogi state, Nigeria
Scientific Title:Acronym
Rational emotive behaviour therapy programme for post traumatic depression of flood victims
Region
| Africa |
Condition
Condition
Keywords: Posttraumatic
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to investigate the effect of REBT on the posttraumatic depressed flood victims in Kogi State.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hamilton Depression Rating Scale (HDRS) Time 1, Time 2, Time 3
Key secondary outcomes
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 not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rational emotive behavioural therapy for depression is a treatment manual developed by David, Kangas, Schnur, and Montgomery (2004) to assist individuals in minimizing the severity of symptoms associated with depression. This manual is a 14-week clinical programme that lasted for 20 sessions.
Interventions/Control_2
The partcipants in waitlisted control group were not active during treatment, however, they received treatment after the main active intervention.
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
| 28 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants must be suffering from either severe or mild depression.
2. Those that been confirmed by clinical psychiatrist/psychologist to be clinically depressed already.
3. Must be readily available for the study.
Key exclusion criteria
1. We excluded participants whose scores on HDRS and GDS were low.
2. Participants that had other forms of medical diseases, perhaps presently receiving medications or pharmaceutical treatment from other experts were excluded
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations, Faculty of Education
Zip code
410001
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL
07066725165
moses.ede@unn.edu.ng
Public contact
Name of contact person
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations
Zip code
410001
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL
07066725165
Homepage URL
moses.ede@unn.edu.ng
Sponsor or person
Institute
University of Nigeria, Nsukka
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nigeria
Address
Faculty of Education, University of Nigeria
Tel
+2348137258914
chiedu.eseadi@unn.edu.ng
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
| 2021 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
106
Results
1. the result suggested that REBT program led to the significant reduction in posttraumatic depression among flood victims in Nigeria.
Results date posted
| 2020 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Severe depressive symtoms
2. Moody
3. Severe posttraumatic stress disorder
Participant flow
Participants flow is in the text
Adverse events
There were no adverse events during treatment.
Outcome measures
Hamilton Depression Rating Scale Pretest Postttest and follow-up
Plan to share IPD
Not applicable
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046849
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