PaedophiliaBEDIT-RCTNCT06607042
Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d SBG V
A study testing Psychotherapy in people with Paedophilia and Hebephilia, run by Charite University, Berlin, Germany.
Trial summary
The main goal of this clinical trial is to learn if psychotherapy works to reduce consumption of child abuse imagages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paedophilia, Hebephilia
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2024to 31 Dec 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at first presentation minimum 18 years
- Voluntary consent to participation on the part of the participant
- At the time of inclusion, no contact with the justice system (ongoing investigation, ongoing criminal proceedings, ongoing prison sentence) due to sexually abusive behavior towards children
- Sexually conspicuous behavior and/or fantasies or impulses that indicate the presence of a pedophilic and/or hebephilic preference disorder.
- An offer of treatment is made when a suspected diagnosis is confirmed or the diagnosis is confirmed
- Feared or recent use of abusive images
- Sufficient knowledge of German
- Voluntary participation in the study and checking the checkbox in the informed consent form before starting participation
Who cannot join
- Age under 18 years
- Lack of consent on the part of the patient
- Exclusion of the presence of a pedophilic and/or hebephilic preference disorder
- Current legal status in the sense of an ongoing investigation or criminal proceedings due to sexually assaultive behavior towards children
- Severe comorbidities: unstable psychotic disorder, organic brain damage, reduced intellectual capacity (IQ below 70), untreated drug or alcohol addiction or persistent harmful use
- Current risk of child sexual abuse and or child sexual abuse that occurred less than 15 years before the start of the study
- An antiandrogenic medication or an opiate antagonist, during therapy start taking a serotonin reuptake inhibitor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: BEDIT-RCT: Randomized Controlled Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d German Social Security Code V
The main goal of this clinical trial is to learn if psychotherapy works to reduce consumption of child abuse imagages.
- Conditions
- Paedophilia, Hebephilia
- Being tested
- Psychotherapy
- Keywords
- Paedophilia, Hebephilia, Child Abuse Images, Sexual Offending
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group receives treatment Receives: Behavioral: Psychotherapy |
| Waitlist Control-group | No intervention | This group consists of individuals randomized to the waitlist condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
Abstinence rates for the consumption of abusive images
Measured: From enrollment to the end of treatment 12 - 18 weeks
Secondary outcomes (6)
Frequency of abstinence rates
Frequency of abstinence rates for the use of child abuse images
Measured: From enrollment to the end of treatment 12 - 18 weeks
Sexual preoccupation
Hypersexual Behavior Inventory - 19, Total Sexual Outcomes
- 19 Items, rated on a scale from 1 (never) bis 5 (very often)
- No reverse-coded items
- Unweighted summation
- minimum = 19, maximum = 95
- Higher scores indicate more frequent or intense hypersexual behavior (negative outcome)
Measured: From enrollment to the end of treatment 12 - 18 weeks
Cognitive distortions about child sexual abuse
Attitudes conducive to child sexual abuse measured by Bumby Molest Scale
- 38 items, rated on a scale from 1 (strongly disagree) to 4 (strongly agree)
- No reverse-coded items
- Unweighted summation
- minimum = 38, maximum = 152
- Higher scores indicate a greater extent of cognitive distortions (negative outcome)
Measured: From enrollment to the end of treatment 12 - 18 weeks
Emotion regulation
Emotion regulation measured by Coping Inventory for Stressful Situations - Short Form
- 24 items, rated on a scale from 1 (not at all typical) to 5 (very typical)
- No reverse-coded items
- Unweighted summation
- 3 subscales (task-oriented, emotion-oriented, avoidance): minimum = 8, maximum = 40 for each
Measured: From enrollment to the end of treatment 12 - 18 weeks
Mental Health
Mental health measured by Hospital Anxiety and Depression Scale
- Two subscales (Anxiety and Depression), each with 7 items, rated from 0 (no symptoms) to 3 (severe symptoms)
- Unweighted summation
- minimum = 0, maximum = 21 per subscale; cutoff score = 11
- Even-numbered items pertain to the Depression subscale, odd-numbered items to the Anxiety subscale
- Items 1, 3, 5, 6, 8, 10, 11, 13 are reverse-coded
Measured: From enrollment to the end of treatment 12 - 18 weeks
General well-being
General well-being measured by European Health Interview Survey - Quality of Life
- 8 items, rated on a scale from 1 (not at all) to 5 (completely)
- No reverse-coded items
- Unweighted summation
- minimum = 8, maximum = 40
- Higher scores represent better quality of life
Measured: From enrollment to the end of treatment 12 - 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start16 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PaedophiliaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, Heinrich-Heine University, Duesseldorf, Klinikum Bamberg, University of Kiel, University Medical Center Mainz, Uniklinikum Giessen und Marburg, University Hospital Ulm, Universitätsklinikum Leipzig, University Hospital Regensburg, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Klaus Michael Beier, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607042
- Sponsor's protocol ID
- 402913
- Other IDs
- 402913
- Acronym
- BEDIT-RCT
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid, R. C., Garos, S. & Carpenter, B. N. (2011). Reliability, Validity, and Psychometric Development of the Hypersexual Behavior Inventory in an Outpatient Sample of Men. Sexual Health & Compulsivity, 18(1), 30-51. https://doi.org/10.1080/10720162.2011.555709
Bumby, K. M. (1996). Assessing the Cognitive Distortions of Child Molesters and Rapists: Development and Validation of the MOLEST and RAPE Scales. Sexual Abuse, 8(1), 37-54. https://doi.org/10.1177/107906329600800105
Endler, N. S., & Parker, J. D. A. (1999). Coping Inventory for Stressful Situations--Short Form (CISS-SF) [Database record]. APA PsycTests.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Schmidt S, Muhlan H, Power M. The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study. Eur J Public Health. 2006 Aug;16(4):420-8. doi: 10.1093/eurpub/cki155. Epub 2005 Sep 1.
PubMed 16141303
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEDIT-RCT: Randomized Controlled Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d German Social Security Code V
- ClinicalTrials.gov ID
- NCT06607042
- Acronym / sponsor ID
- BEDIT-RCT / 402913
- Conditions
- Paedophilia, Hebephilia
- Keywords
- Paedophilia, Hebephilia, Child Abuse Images, Sexual Offending
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Hannover Medical School, Heinrich-Heine University, Duesseldorf, Klinikum Bamberg, University of Kiel, University Medical Center Mainz, Uniklinikum Giessen und Marburg, University Hospital Ulm, Universitätsklinikum Leipzig, University Hospital Regensburg, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2024 (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 main goal of this clinical trial is to learn if psychotherapy works to reduce consumption of child abuse imagages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PsychotherapyThis group receives treatment |
| Waitlist Control-group | No intervention | –This group consists of individuals randomized to the waitlist condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age at first presentation minimum 18 years
- Voluntary consent to participation on the part of the participant
- At the time of inclusion, no contact with the justice system (ongoing investigation, ongoing criminal proceedings, ongoing prison sentence) due to sexually abusive behavior towards children
- Sexually conspicuous behavior and/or fantasies or impulses that indicate the presence of a pedophilic and/or hebephilic preference disorder.
- An offer of treatment is made when a suspected diagnosis is confirmed or the diagnosis is confirmed
Key exclusion criteria (7 listed)
- Age under 18 years
- Lack of consent on the part of the patient
- Exclusion of the presence of a pedophilic and/or hebephilic preference disorder
- Current legal status in the sense of an ongoing investigation or criminal proceedings due to sexually assaultive behavior towards children
- Severe comorbidities: unstable psychotic disorder, organic brain damage, reduced intellectual capacity (IQ below 70), untreated drug or alcohol addiction or persistent harmful use
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 |
|---|---|---|
| PsychotherapyPsychotherapy according to the Berlin Dissexuality Therapy (BEDIT) | Behavioural | Intervention Group |
Primary outcome
Abstinence
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Abstinence rates for the consumption of abusive images
6 secondary outcomes
Frequency of abstinence rates
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Sexual preoccupation
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Cognitive distortions about child sexual abuse
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Emotion regulation
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Mental Health
Time frame: From enrollment to the end of treatment 12 - 18 weeks
General well-being
Time frame: From enrollment to the end of treatment 12 - 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- BackgroundReid, R. C., Garos, S. & Carpenter, B. N. (2011). Reliability, Validity, and Psychometric Development of the Hypersexual Behavior Inventory in an Outpatient Sample of Men. Sexual Health & Compulsivity, 18(1), 30-51. https://doi.org/10.1080/10720162.2011.555709
- BackgroundBumby, K. M. (1996). Assessing the Cognitive Distortions of Child Molesters and Rapists: Development and Validation of the MOLEST and RAPE Scales. Sexual Abuse, 8(1), 37-54. https://doi.org/10.1177/107906329600800105
- BackgroundEndler, N. S., & Parker, J. D. A. (1999). Coping Inventory for Stressful Situations--Short Form (CISS-SF) [Database record]. APA PsycTests.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 16141303Schmidt S, Muhlan H, Power M. The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study. Eur J Public Health. 2006 Aug;16(4):420-8. doi: 10.1093/eurpub/cki155. Epub 2005 Sep 1.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Paedophilia and Hebephilia, run by Charite University, Berlin, Germany.
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 8 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Klaus Michael Beier, Prof. Dr. med. Dr. phil. (+49 30450529301, klaus.beier@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: From enrollment to the end of treatment 12 - 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607042, which also lists 5 linked publications.
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 23 Sep 2024.