UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Rational Emotive Behaviour Therapy on Depressive Symptoms in a Sample of Parents of Children with Intellectual Disability
Acronym	Effect of Rational Emotive Behaviour Therapy on Depressive Symptoms
Scientific Title	Effect of Rational Emotive Behaviour Therapy on Depressive Symptoms in a Sample of Parents of Children with Intellectual Disability
Scientific Title:Acronym	Effect of Rational Emotive Behaviour Therapy on Depressive Symptoms
Region	Africa

Condition
Condition	Depression
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study tested the effect of a rational emotive behaviour therapy intervention in reducing depressive symptoms in a selected sample of parents of children with intellectual disabilities in Nigeria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Goldberg depression scale
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	Placebo
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	This manual is a 14-week programme housing two session per week, that is 12 weeks for the active treatment, and two weeks fellow-up meeting. Each session lasts for 50minutes. Weeks 1-4 (initial phase: 2 sessions each week) with sessions 1-8, Weeks 5-8 (middle phase: 2 sessions each week) with sessions 9-16, Weeks 9-12 (final phase: 1 session each week) comprising sessions 17-20.
Interventions/Control_2	The participants in control group were treated by the researchers using a TAU manual that has often been used by therapists in their regular practice. This manual was modified by the counselling psychologists in collaboration with research team using past treatment guide for psychological stress. This is a 20-session that lasted for 50 minutes each and were held twice per week for 5 consecutive weeks. It served as placebo, just to keep the participants in control group busy.
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	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Having presence of either moderate or severe depression.
Key exclusion criteria	Already receiving treatment elsewhere Other problems some refused to disclose to the research team.
Target sample size	123

Research contact person
Name of lead principal investigator	1st name Leonard Middle name T Last name Ugwuanyi
Organization	University of Nigeria, Nsukka
Division name	Department of Educational Foundations
Zip code	410001
Address	Department of Educational Foundations, University of Nigeria, Nsukka.
TEL	+2347037280006
Email	leonaed.ugwuanyi@unn.edu.ng

Public contact
Name of contact person	1st name Moses Middle name Onyemaechi Last name Ede
Organization	University of Nigeria
Division name	Department of Educational Foundations
Zip code	410001
Address	Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka
TEL	+2347066725165
Homepage URL
Email	moses.ede@unn.edu.ng

Sponsor
Institute	University of Nigeria, Nsukka
Institute
Department

Funding Source
Organization	University of Nigeria, Nsukka
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	2Department of Educational Foundations
Tel	+2347066725165
Email	moses.ede@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 12 Month 31 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	123
Results	Thereafter, the REBT group revealed a considerable decrease in scores, which was sustained, while the control group showed no change in scores. ANCOVA analysis established a significant between-group difference immediately and three months after the intervention.
Results date posted	2021 Year 12 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	moderate and high depressive symptoms
Participant flow
Adverse events	No adverse effects
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 06 Day
Date of IRB	2020 Year 08 Month 10 Day
Anticipated trial start date	2020 Year 09 Month 26 Day
Last follow-up date	2021 Year 02 Month 16 Day
Date of closure to data entry	2021 Year 04 Month 07 Day
Date trial data considered complete	2021 Year 05 Month 29 Day
Date analysis concluded	2021 Year 06 Month 05 Day

Other
Other related information

Management information
Registered date	2021 Year 12 Month 28 Day
Last modified on	2021 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053060