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Clinical Trials/NCT06607042
NCT06607042Not yet recruitingNot Applicable

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

Charite University, Berlin, Germany0 sites60 target enrollmentStarted: September 16, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Abstinence
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Intervention Group

Experimental

This group receives treatment

Intervention: Psychotherapy (Behavioral)

Waitlist Control-group

No Intervention

This group consists of individuals randomized to the waitlist condition

Outcomes

Primary Outcomes

Abstinence

Time Frame: From enrollment to the end of treatment 12 - 18 weeks

Abstinence rates for the consumption of abusive images

Secondary Outcomes

  • 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)
  • General well-being(From enrollment to the end of treatment 12 - 18 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Klaus Michael Beier

Director, Institute for Sexual Research and Sexual Medicine

Charite University, Berlin, Germany

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