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Not yet recruiting NCT06607042

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

No phase Interventional Paedophilia Hebephilia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychotherapy.
Who it may be relevant to
Registry conditions: Paedophilia, Hebephilia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Behavioral Psychotherapy
    Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Primary outcome measures

  • Abstinence [Time frame: From enrollment to the end of treatment 12 - 18 weeks]
Secondary outcome measures (6)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 6880820
  • 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

Identifiers

NCT: NCT06607042 · 402913 · 402913

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗