UMIN-CTR Clinical Trial
| 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 (Ver. 1) |
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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 |
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| Condition | ||
| Condition | VIOLENT SEXUAL ATTITUDES | |
| Classification by specialty |
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| 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 |
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| 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. | |
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| Interventions/Control_9 | ||
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 | |||||||
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| Organization | University of Nigeria, Nsukka | ||||||
| Division name | Department of Educational Foundations | ||||||
| Zip code | 410001 | ||||||
| Address | Nsukka | ||||||
| TEL | +2347066725165 | ||||||
| moses.ede@unn.edu.ng | |||||||
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| 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 | |
| Institute | Otusum |
| Institute | |
| Department | |
| Funding Source | |
| Organization | University of Nigeria, Nsukka |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
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| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| 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 |
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| Participant flow | Not applicable |
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| Adverse events | There was no adverse events during the treatment |
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| Outcome measures | Not applicable |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042329 |
