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

NCT06607042 | Not Yet Recruiting DMC

• 1 other identifier: 402913
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Paedophilia; Hebephilia

Keywords

Paedophilia; Hebephilia; Child Abuse Images; Sexual Offending

Outcome Measures

Primary Outcomes (1)

• Abstinence

  Abstinence rates for the consumption of abusive images

  From enrollment to the end of treatment 12 - 18 weeks

Secondary Outcomes (6)

• Frequency of abstinence rates

  From enrollment to the end of treatment 12 - 18 weeks

• Sexual preoccupation

  From enrollment to the end of treatment 12 - 18 weeks

• Cognitive distortions about child sexual abuse

  From enrollment to the end of treatment 12 - 18 weeks

• Emotion regulation

  From enrollment to the end of treatment 12 - 18 weeks

• Mental Health

  From enrollment to the end of treatment 12 - 18 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group receives treatment

Behavioral: Psychotherapy

Waitlist Control-group

NO INTERVENTION

This group consists of individuals randomized to the waitlist condition

Interventions

Psychotherapy BEHAVIORAL

Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at first presentation minimum 18 years
• Voluntary consent to participation on the part of the participant
• 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

You may not qualify if:

• Age under 18 years
• Lack of consent on the part of the patient
• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Hannover Medical School: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Klinikum Bamberg: collaborator
• Universitätsklinikum Kiel: collaborator
• University Medical Center Mainz: collaborator
• Uniklinikum Giessen und Marburg: collaborator
• University Hospital Ulm: collaborator
• Universitätsklinikum Leipzig: collaborator
• University Hospital Regensburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Related Publications (5)

• 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

  BACKGROUND

• 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

  BACKGROUND

• Endler, N. S., & Parker, J. D. A. (1999). Coping Inventory for Stressful Situations--Short Form (CISS-SF) [Database record]. APA PsycTests.

  BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 16141303 BACKGROUND

MeSH Terms

Conditions

Pedophilia

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Paraphilic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Klaus Michael Beier, Prof. Dr. med. Dr. phil.

CONTACT

+49 30450529301; klaus.beier@charite.de

Tillmann Krüger, Prof. Dr. med.

CONTACT

+49 5115322470; krueger.tillmann@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Sexual Research and Sexual Medicine

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 23, 2024
• Study Start: September 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share