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NCT Number: NCT06607042

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

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

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Key information

Conditions

Paedophilia Hebephilia Mental Disorders Paraphilic Disorders Pedophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Behavioral

Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Primary outcomes

  1. Abstinence

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

    Abstinence rates for the consumption of abusive images

Secondary outcomes

  1. Frequency of abstinence rates

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

    Frequency of abstinence rates for the use of child abuse images

  2. Sexual preoccupation

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

    Hypersexual Behavior Inventory - 19, Total Sexual Outcomes

    • 19 Items, rated on a scale from 1 (never) bis 5 (very often)
    • No reverse-coded items
    • Unweighted summation
    • minimum = 19, maximum = 95
    • Higher scores indicate more frequent or intense hypersexual behavior (negative outcome)

  3. Cognitive distortions about child sexual abuse

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

    Attitudes conducive to child sexual abuse measured by Bumby Molest Scale

    • 38 items, rated on a scale from 1 (strongly disagree) to 4 (strongly agree)
    • No reverse-coded items
    • Unweighted summation
    • minimum = 38, maximum = 152
    • Higher scores indicate a greater extent of cognitive distortions (negative outcome)

  4. Emotion regulation

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

    Emotion regulation measured by Coping Inventory for Stressful Situations - Short Form

    • 24 items, rated on a scale from 1 (not at all typical) to 5 (very typical)
    • No reverse-coded items
    • Unweighted summation
    • 3 subscales (task-oriented, emotion-oriented, avoidance): minimum = 8, maximum = 40 for each

  5. Mental Health

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

    Mental health measured by Hospital Anxiety and Depression Scale

    • Two subscales (Anxiety and Depression), each with 7 items, rated from 0 (no symptoms) to 3 (severe symptoms)
    • Unweighted summation
    • minimum = 0, maximum = 21 per subscale; cutoff score = 11
    • Even-numbered items pertain to the Depression subscale, odd-numbered items to the Anxiety subscale
    • Items 1, 3, 5, 6, 8, 10, 11, 13 are reverse-coded

  6. General well-being

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

    General well-being measured by European Health Interview Survey - Quality of Life

    • 8 items, rated on a scale from 1 (not at all) to 5 (completely)
    • No reverse-coded items
    • Unweighted summation
    • minimum = 8, maximum = 40
    • Higher scores represent better quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+49 30450529301

Tillmann Krüger, Prof. Dr. med.

CONTACT

[email protected]

+49 5115322470

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Hannover Medical School
  • Heinrich-Heine University, Duesseldorf
  • Klinikum Bamberg
  • Uniklinikum Giessen und Marburg
  • University Hospital Regensburg
  • University Hospital Ulm
  • University Medical Center Mainz
  • University of Kiel
  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Leipzig

Registry information

Official study 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

Acronym: BEDIT-RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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