Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism

NCT06098521 | Recruiting DMC

• 1 other identifier: 2023-04498-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Offending Behavior

Keywords

Sexual Offending; Recidivism; Cognitive behavioral therapy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in The Sex Offender Treatment Intervention and Progress Scale (SOTIPS) score, a sum score based on a 11 selected items.

  A risk/need measurement based on the SOTIPS assessment, limited to a summation measure (0-33 points; higher scores indicate higher risk) based on the following items: Sexual Offense Responsibility, Sexual Attitudes, Sexual Risk Management, Criminal Rule-Breaking Behavior, Criminal Rule-Breaking Attitudes, Stage of Change, Cooperation with Treatment, Emotional Management, Problem Solving, Impulsivity, and Social Influence.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

Secondary Outcomes (5)

• Change in central criminogenic needs, i.e., social problem-solving ability and emotion regulation skills.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

• Change in central criminogenic needs, i.e., social problem-solving ability and emotion regulation skills.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

• Motivation for change.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

• Change in sexual urges involving children.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

• Change in self-reported risk.

  1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).

Study Arms (2)

CONSENT and Follow-up

EXPERIMENTAL

The therapy in the CONSENT program will be delivered twice a week (total time 12 ± 2 weeks), with measurement after 16±2 weeks. Participants in this arm will have a follow-up period of 16±2 weeks.

Behavioral: CONSENT

Waiting list and CONSENT

EXPERIMENTAL

Participants will be on waiting list for 16±2 weeks. After waiting list participants are offered the CONSENT program including therapy delivered twice a week (total time 12 ± 2 weeks), with measurement after for 16±2 weeks.

Behavioral: CONSENT

Interventions

CONSENT BEHAVIORAL

The CONSENT program is a risk-, need- and responsivity (RNR) based CBT program primarily focused on reducing risk of sexual reoffending, that consists of 18-26 one-to-one sessions in correctional settings.

CONSENT and Follow-up; Waiting list and CONSENT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• and the risk of relapse in sexual offenses is assessed as average risk of relapse in sexual offenses with Risk Matrix 2000
• and a total score (all items included) on The Sex Offender Treatment Intervention and Progress Scale (SOTIPS) of ≤20
• and written informed consent.
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Prison and Probation Services: collaborator

Study Sites (2)

Karolinska Institutet

Stockholm, Stockholm County, 113 64, Sweden

RECRUITING

Swedish Prison and Probation Service

Norrköping, 602 22, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Recidivism

Interventions

Consent Forms

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior

Intervention Hierarchy (Ancestors)

Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Christoffer Rahm, M.D., Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Lätth, MSc Psych

CONTACT

+46725301590; johanna.latth@ki.se

Louise Starfelt Sutton, Ph.D.

CONTACT

+46706792980; louise.starfeltsutton@kriminalvarden.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized waiting list controlled trial

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: November 14, 2023
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)