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Clinical Trial Summary

The goal of this randomized controlled trial is to investigate the effects of cognitive behavioral therapy (CBT) on sexual recidivism risk in a Swedish sample of incarcerated men convicted of sexual offenses. The main question it aims to answer is: Does the CBT program CONSENT reduce the risk of recidivism in sexual offenses among males convicted of sexual offending? The CONSENT program, specifically targeting risk factors for sexual recidivism, will be compared with a waiting list. The evaluation will focus on potential change in dynamic risk factors for sexual recidivism. The study is part of the project Preventing Sexual Abuse: CBT Programs for Convicted Men and Women in a Correctional Setting.


Clinical Trial Description

The aim of this study is to evaluate the short-term effects of the CONSENT program. To improve participation and responsivity and minimize any unintentional side effects, men's experiences of CONSENT are also sought. Firstly, clients' changes will be examined in two complementary ways: through professionals' assessments and through clients' assessments using questionnaires. Secondly, changes in risk will be examined at two time points (after the program and at the 4-month follow-up), and the willingness to change in order to obtain additional complementary measures of the intended change process. The primary research question and hypothesis, based on professionals' assessment (assessment not made by the same person conducting the program), is as follows: 1. Does the CONSENT program reduce the risk of recidivism in sexual offenses, as assessed by professionals, among males convicted of sexual offending (initially assessed as having a moderate risk of sexual offense recidivism)? The main hypothesis is that the estimated risk of recidivism in sexual offenses will be reduced more among men participating in CONSENT than among men on the waiting list, based on professionals' assessments. The following secondary research questions complement the primary question: 2. Does social problem-solving change during participation in CONSENT? 3. Does emotional self-regulation change during participation in CONSENT? 4. Does the willingness to change among participants in CONSENT change? 5. What changes are sustained at the four-month follow-up assessment? 6. Does self-reported risk of committing sexual offenses against children change during participation in CONSENT? 7. Do sexual urges involving children change during participation in CONSENT? Participants will also report any negative side effects and serious adverse events resulting from participating in CONSENT, as well as describe positive and negative experiences related to their participation. Please note that research questions 5 and 6 apply only to individuals convicted of sexual offenses against children and/or who indicate a sexual interest in children in the LASSIE instrument measuring paraphilic interests. The trial will be conducted within the Swedish Prison and Probation Service at prisons specialized in individuals convicted of sexual offending. ;


Study Design


NCT number NCT06098521
Study type Interventional
Source Karolinska Institutet
Contact Johanna Lätth, MSc Psych
Phone +46725301590
Email johanna.latth@ki.se
Status Not yet recruiting
Phase N/A
Start date November 14, 2023
Completion date February 27, 2026