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

Charité University Medicine Berlin

Status: Not yet enrolling

Conditions: Paedophilia; Hebephilia

Treatments: Behavioral: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06607042

402913 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This group receives treatment

Treatment:

Behavioral: Psychotherapy

Waitlist Control-group

No Intervention group

Description:

This group consists of individuals randomized to the waitlist condition