NCT06098521 Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism
| NCT ID | NCT06098521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Sexual Offending Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2026-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 228 participants in total. It began in 2023-11-14 with a primary completion date of 2026-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
The study population is a subgroup of the study population in another study within the same project. Eligibility criteria for that study: Inclusion Criteria: * Men aged 18 and above sentenced to imprisonment within the Swedish Prison and Probation Service. * and offense falls under Chapter 6 of the Swedish Penal Code concerning sexual offenses or relates to child pornography offenses. * and risk of recidivism for sexual offenses is assessed as "average" or higher according to the Risk Matrix 2000. * and provided signed informed consent. Exclusion Criteria: * Individuals with apparent influence at the time of assessment due to severe psychiatric conditions such as pronounced psychotic symptoms or dementia. * or difficulties conducting interviews and self-assessments/surveys due to language barriers in understanding the Swedish language. * or difficulties in fully understanding the conditions for consenting to participate. Additional eligibility criteria for the current trial: Inclusion Criteria * Inclusion criteria for Consent are met: * and the risk of relapse in sexual offenses is assessed as average risk of relapse in sexual offenses with Risk Matrix 2000 * and the participant does not meet the inclusion criteria for SEIF (medium to high risk of relapse in sexual offenses and concurrent paraphilia and/or sexual preoccupation and/or emotional identification with children and/or extensive responsivity issues). * and a total score (all items included) on The Sex Offender Treatment Intervention and Progress Scale (SOTIPS) of ≤20 * and ≥9 months to halftime of sentence, when it becomes possible to apply for reintegration measures (including 12±2 weeks in the program and 4 weeks without the program, 16±2 weeks on the waitlist/follow-up, and time for assessment and inclusion) or ≥9 months left until conditional release and special conditions that state that reintegration measures are not allowed. * and written informed consent. Exclusion Criteria \- Any exclusion criteria for Consent are met: difficulties in understanding the program's content and carrying it out due to difficulties in understanding the Swedish language * or severe or ongoing unstable psychiatric conditions or other conditions that hinder participation (high suicide risk, significant psychotic symptoms, diagnosed intellectual disability, or other serious cognitive illness such as dementia) * or ongoing participation in another psychological program. If potential research subjects have other programs in their sentence plan, participation in the study will be prioritized if it is deemed appropriate in individual cases.
Contact & Investigator
Christoffer Rahm, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06098521 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Sexual Offending Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06098521 currently recruiting?
Yes, NCT06098521 is actively recruiting participants. Contact the research team at johanna.latth@ki.se for enrollment information.
Where is the NCT06098521 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Norrköping, Sweden.
Who is sponsoring the NCT06098521 clinical trial?
NCT06098521 is sponsored by Karolinska Institutet. The principal investigator is Christoffer Rahm, M.D., Ph.D. at Karolinska Institutet. The trial plans to enroll 228 participants.