Status:
RECRUITING
Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Swedish Prison and Probation Services
Conditions:
Sexual Offending Behavior
Eligibility:
MALE
18+ years
Phase:
NA
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 o...
Detailed 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 ...
Eligibility Criteria
Inclusion
- The study population is a subgroup of the study population in another study within the same project. Eligibility criteria for that study:
- 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
- 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.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06098521
Start Date
November 14 2023
End Date
February 27 2026
Last Update
October 10 2024
Active Locations (2)
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1
Karolinska Institutet
Stockholm, Stockholm County, Sweden, 113 64
2
Swedish Prison and Probation Service
Norrköping, Sweden, 602 22