Clinical trial NCT06607042: Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d SBG V
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Paedophilia
Hebephilia
Keywords: Paedophilia
Hebephilia
Child Abuse Images
Sexual Offending
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
name: Heinrich-Heine University, Duesseldorf
name: Klinikum Bamberg
name: Universitätsklinikum Kiel
name: University Medical Center Mainz
name: Uniklinikum Giessen und Marburg
name: University Hospital Ulm
name: Universitätsklinikum Leipzig
name: University Hospital Regensburg
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2024-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Abstinence
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
Secondary outcomes:
measure: Frequency of abstinence rates
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
measure: Sexual preoccupation
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
measure: Cognitive distortions about child sexual abuse
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
measure: Emotion regulation
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
measure: Mental Health
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
measure: General well-being
timeFrame: From enrollment to the end of treatment 12 - 18 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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
citation: 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
citation: Endler, N. S., & Parker, J. D. A. (1999). Coping Inventory for Stressful Situations--Short Form (CISS-SF) [Database record]. APA PsycTests.
citation: 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.
citation: Schmidt 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.