Sexual Offending BehaviorNCT06098521
Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism
A study testing CONSENT in people with Sexual Offending Behavior, run by Karolinska Institutet at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual Offending Behavior
- What is being tested?
- CONSENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 2 sitesSweden
- Study dates
- 14 Nov 2023to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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).
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- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Swedish Prison and Probation Service
Norrköping, 602 22
Johanna Lätth, MSc Psych, +46725301590, johanna.latth@ki.se
Louise Starfelt Sutton, Ph.D., +46706792980, Louise.StarfeltSutton@kriminalvarden.se
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 113 64
Christoffer Rahm, MD, christoffer.rahm@ki.se
Christoffer Rahm, MD
About this study
Official title: 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.
Read the 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:
- 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:
- Does social problem-solving change during participation in CONSENT?
- Does emotional self-regulation change during participation in CONSENT?
- Does the willingness to change among participants in CONSENT change?
- What changes are sustained at the four-month follow-up assessment?
- Does self-reported risk of committing sexual offenses against children change during participation in CONSENT?
- 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.
- Conditions
- Sexual Offending Behavior
- Being tested
- CONSENT
- Keywords
- Sexual Offending, Recidivism, Cognitive behavioral therapy, Randomized controlled trial
- Medical subject headings
- Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONSENTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CONSENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured with the Social Problem Solving Inventory-Revised (SPSI-R) (25-125 points, higher scores indicate more difficulties).
Measured: 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.
Measured with the Emotion Regulation Scale-Brief version (DERS-16)(16-80 points; higher scores indicate more difficulties).
Measured: 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.
Measured with The Change Questionnaire (TCQ)(0-30 points, higher scores indicate more motivation).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start14 Nov 2023
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Offending BehaviorStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized waiting list controlled trial
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Prison and Probation Services
- Responsible party
- Principal investigator, Christoffer Rahm, Karolinska Institutet
- Investigators
- Christoffer Rahm, M.D., Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098521
- Sponsor's protocol ID
- 2023-04498-01
- Other IDs
- 2023
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project CONSENT: a Randomized Controlled Trial to Evaluate Cognitive Behavioral Therapy for the Prevention of Sexual Recidivism
- ClinicalTrials.gov ID
- NCT06098521
- Acronym / sponsor ID
- 2023-04498-01
- Conditions
- Sexual Offending Behavior
- Keywords
- Sexual Offending, Recidivism, Cognitive behavioral therapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Prison and Probation Services
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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:
- Does social problem-solving change during participation in CONSENT?
- Does emotional self-regulation change during participation in CONSENT?
- Does the willingness to change among participants in CONSENT change?
- What changes are sustained at the four-month follow-up assessment?
- Does self-reported risk of committing sexual offenses against children change during participation in CONSENT?
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized waiting list controlled trial
| Arm | Type | Receives |
|---|---|---|
| CONSENT and Follow-up | Experimental | Behavioral: CONSENTThe 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. |
| Waiting list and CONSENT | Experimental | Behavioral: CONSENTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- and the risk of relapse in sexual offenses is assessed as average risk of relapse in sexual offenses with Risk Matrix 2000
Key exclusion criteria (7 listed)
- 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.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONSENTThe 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. | Behavioural | CONSENT and Follow-up, Waiting list and CONSENT |
Primary outcome
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.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Rahm, M.D., Ph.D. principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONSENT in people with Sexual Offending Behavior, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Lätth, MSc Psych (+46725301590, johanna.latth@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.