UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046504 |
|---|---|
| Receipt number | R000053060 |
| Scientific Title | Effect of Rational Emotive Behaviour Therapy on Depressive Symptoms in a Sample of Parents of Children with Intellectual Disability |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2021/12/28 15:19:59 |
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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
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
moses.ede@unn.edu.ng
Sponsor or person
Institute
University of Nigeria, Nsukka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053060
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| Registered date | File name |
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