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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037145
Receipt No. R000042329
Scientific Title CBT FOR VIOLENT SEXUAL ATTITUDES OF ADULT SEX OFFENDERS
Date of disclosure of the study information 2019/06/24
Last modified on 2019/06/24

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Basic information
Public title EVALUATION OF THE IMPACT OF CBT ON VIOLENT SEXUAL ATTITUDES AMONG ADULT SEX OFFENDERS IN NIGERIAN PRISONS
Acronym CBTI
Scientific Title CBT FOR VIOLENT SEXUAL ATTITUDES OF ADULT SEX OFFENDERS
Scientific Title:Acronym CBT FOR VIOLENT SEXUAL ATTITUDES OF ADULT SEX OFFENDERS
Region
Africa

Condition
Condition VIOLENT SEXUAL ATTITUDES
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The goal of this study is therefore to evaluate the impact of cognitive behaviour therapy intervention CBTI on violent sexual attitudes among adult sex offenders in Nigerian prisons.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Compulsive Sexual Behavior Inventory (CSBI-22)
Hypersexual Behavior Inventory (HBI)
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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The CBTI application was for 16 weeks duration with one session of 90 minutes per week.
Interventions/Control_2 Participants in the no-intervention group received nothing.
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
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male
Key inclusion criteria The inclusion criteria for participants were based on the classification of the Diagnostic Statistical Mental Manual-V (DSM-V) of compulsive sexual disorder. Violent sex offenders were further selected and assessed on the basis of whether they are convicted/awaiting trial, in a correctional institution, and inclination to treatment.
Key exclusion criteria Others (sex offenders) were excluded because some persons (n=17) declined stressing that their reasons were personal, 22 sex offenders said that they have completed imprisonment sentence, receiving medical/pharmacological treatment, and not ready to receive treatment. Finally, 5 sex offenders had low scores as they do not have an intense preoccupation with sexual urges, and behaviours that would warrant psychotherapeutic treatment. That is, they do not have recurring and extreme sexual urges, and attitudes, leading to severe clinically significant distress as in DSM-V inclusion criteria.
Target sample size 45

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
Zip code 410001
Address Nsukka
TEL +2347066725165
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 +2347066725165
Homepage URL
Email moses.ede@unn.edu.ng

Sponsor
Institute Otusum
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 Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
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
2019 Year 06 Month 24 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 45
Results
The study established that the violent sexual attitudes of adult sex offenders in Nigeria prisons, Enugu were significantly affected by the effects of cognitive behavioural therapy intervention as measured by HBI and CSBI. The present study also found that coping rates among adult sex offenders with violent sexual attitudes were significantly decreased in favour of participants in the treatment group at Time 2 and Time 3 that is post-test and follow-up evaluation.
Results date posted
2019 Year 06 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sexual preference
Heterosexual  
Homosexual  
Bisexual
Criminal History
Once
Twice
thrice
Sexual Offense Behaviour
Raping
Child sexual abuse
Force penetration of female genital organ
Sexual assault
Length of Incarceration
Six months
One year
Two years
Three years
Participant flow
Not applicable
Adverse events
There was no adverse events during the treatment
Outcome measures
Not applicable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 09 Day
Date of IRB
2014 Year 05 Month 10 Day
Anticipated trial start date
2014 Year 08 Month 12 Day
Last follow-up date
2015 Year 05 Month 18 Day
Date of closure to data entry
2015 Year 07 Month 02 Day
Date trial data considered complete
2015 Year 10 Month 16 Day
Date analysis concluded
2016 Year 02 Month 24 Day

Other
Other related information

Management information
Registered date
2019 Year 06 Month 24 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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