UMIN-CTR Clinical Trial

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
Email	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
Email	moses.ede@unn.edu.ng

Sponsor
Institute	University of Nigeria, Nsukka
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046849