Skip to content

Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d SBG V

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06607042
Acronym
BEDIT-RCT
Enrollment
60
Registered
2024-09-23
Start date
2024-09-16
Completion date
2025-12-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hebephilia, Paedophilia

Keywords

Paedophilia, Hebephilia, Child Abuse Images, Sexual Offending

Brief summary

The main goal of this clinical trial is to learn if psychotherapy works to reduce consumption of child abuse imagages.

Interventions

BEHAVIORALPsychotherapy

Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Sponsors

Hannover Medical School
CollaboratorOTHER
Heinrich-Heine University, Duesseldorf
CollaboratorOTHER
Klinikum Bamberg
CollaboratorOTHER
Universitätsklinikum Kiel
CollaboratorUNKNOWN
University Medical Center Mainz
CollaboratorOTHER
Uniklinikum Giessen und Marburg
CollaboratorUNKNOWN
University Hospital Ulm
CollaboratorOTHER
Universitätsklinikum Leipzig
CollaboratorOTHER
University Hospital Regensburg
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
AbstinenceFrom enrollment to the end of treatment 12 - 18 weeksAbstinence rates for the consumption of abusive images

Secondary

MeasureTime frameDescription
Sexual preoccupationFrom enrollment to the end of treatment 12 - 18 weeksHypersexual 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)
Cognitive distortions about child sexual abuseFrom enrollment to the end of treatment 12 - 18 weeksAttitudes 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)
Frequency of abstinence ratesFrom enrollment to the end of treatment 12 - 18 weeksFrequency of abstinence rates for the use of child abuse images
Mental HealthFrom enrollment to the end of treatment 12 - 18 weeksMental 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
General well-beingFrom enrollment to the end of treatment 12 - 18 weeksGeneral 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
Emotion regulationFrom enrollment to the end of treatment 12 - 18 weeksEmotion 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

Contacts

Primary ContactKlaus Michael Beier, Prof. Dr. med. Dr. phil.
klaus.beier@charite.de+49 30450529301
Backup ContactTillmann Krüger, Prof. Dr. med.
krueger.tillmann@mh-hannover.de+49 5115322470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026