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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000037145
受付番号 R000042329
科学的試験名
一般公開日(本登録希望日) 2019/06/24
最終更新日 2019/06/24

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
EVALUATION OF THE IMPACT OF CBT ON VIOLENT SEXUAL ATTITUDES AMONG ADULT SEX OFFENDERS IN NIGERIAN PRISONS
一般向け試験名略称/Acronym
CBTI
科学的試験名/Scientific Title
CBT FOR VIOLENT SEXUAL ATTITUDES OF ADULT SEX OFFENDERS
科学的試験名略称/Scientific Title:Acronym
CBT FOR VIOLENT SEXUAL ATTITUDES OF ADULT SEX OFFENDERS
試験実施地域/Region
アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
VIOLENT SEXUAL ATTITUDES
疾患区分1/Classification by specialty
成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Compulsive Sexual Behavior Inventory (CSBI-22)
Hypersexual Behavior Inventory (HBI)
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification はい/YES
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking はい/YES
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
The CBTI application was for 16 weeks duration with one session of 90 minutes per week.
介入2/Interventions/Control_2
Participants in the no-intervention group received nothing.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
49 歳/years-old 以下/>=
性別/Gender 男/Male
選択基準/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.
除外基準/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.
目標参加者数/Target sample size 45

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Moses
ミドルネーム Onyemaechi
Ede
所属組織/Organization
University of Nigeria, Nsukka
所属部署/Division name
Department of Educational Foundations
郵便番号/Zip code 410001
住所/Address
Nsukka
電話/TEL +2347066725165
Email/Email moses.ede@unn.edu.ng

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Moses
ミドルネーム Onyemaechi
Ede
組織名/Organization
University of Nigeria, Nsukka
部署名/Division name
Department of Educational Foundations
郵便番号/Zip code 410001
住所/Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
電話/TEL +2347066725165
試験のホームページURL/Homepage URL
Email/Email moses.ede@unn.edu.ng

実施責任組織/Sponsor
機関名/Institute その他 Otusum
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 University of Nigeria, Nsukka
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
University of Nigeria
住所/Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
電話/Tel +2347066725165
Email/Email moses.ede@unn.edu.ng

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 06 24

関連情報/Related information
プロトコル掲載URL/URL releasing protocol Not applicable
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications Not applicable
組み入れ参加者数/Number of participants that the trial has enrolled 45
主な結果/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.
主な結果入力日/Results date posted
2019 06 24
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/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
参加者の流れ/Participant flow
Not applicable
有害事象/Adverse events
There was no adverse events during the treatment
評価項目/Outcome measures
Not applicable
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2014 04 09
倫理委員会による承認日/Date of IRB
2014 05 10
登録・組入れ開始(予定)日/Anticipated trial start date
2014 08 12
フォロー終了(予定)日/Last follow-up date
2015 05 18
入力終了(予定)日/Date of closure to data entry
2015 07 02
データ固定(予定)日/Date trial data considered complete
2015 10 16
解析終了(予定)日/Date analysis concluded
2016 02 24

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2019 06 24
最終更新日/Last modified on
2019 06 24


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042329
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042329

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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