Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism

October 8, 2024 updated by: Christoffer Rahm, Karolinska Institutet

Project CONSENT: a Randomized Controlled Trial to Evaluate Cognitive Behavioral Therapy for the Prevention of Sexual Recidivism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Norrköping, Sweden, 602 22
      • Stockholm, Sweden, 113 64
        • Recruiting
        • Karolinska Institutet
        • Contact:
        • Contact:
          • Christoffer Rahm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CONSENT and Follow-up
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
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.
Experimental: Waiting list and CONSENT
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in The Sex Offender Treatment Intervention and Progress Scale (SOTIPS) score, a sum score based on a 11 selected items.
Time Frame: 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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in central criminogenic needs, i.e., social problem-solving ability and emotion regulation skills.
Time Frame: 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).
Measured with the Social Problem Solving Inventory-Revised (SPSI-R) (25-125 points, higher scores indicate more difficulties).
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.
Time Frame: 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).
Measured with the Emotion Regulation Scale-Brief version (DERS-16)(16-80 points; higher scores indicate more difficulties).
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.
Time Frame: 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).
Measured with The Change Questionnaire (TCQ)(0-30 points, higher scores indicate more motivation).
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.
Time Frame: 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).
Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more urges). This outcome is only for the subgroup that is convicted of a child sexual offence or self-report a sexual interest in 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.
Time Frame: 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).
Measured with a version of the Sexual Child Molestation Risk Assessment (SChiMRA) (visual analogue scale 0-10, higher points indicate higher risk). Each of the three items are reported separately. This outcome is only for the subgroup that is convicted of a child sexual offence or self-report a sexual interest in 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swedish Prison and Probation Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoffer Rahm, M.D., Ph.D., Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-04498-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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