UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037145 |
|---|---|
| Receipt number | 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 02:18:57 |
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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
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
moses.ede@unn.edu.ng
Sponsor or person
Institute
Otusum
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
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042329
