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

NCT ID: NCT06607042

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Paedophilia Hebephilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

This group receives treatment

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Waitlist Control-group

This group consists of individuals randomized to the waitlist condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy

Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

Klinikum Bamberg

OTHER

Sponsor Role collaborator

Universitätsklinikum Kiel

UNKNOWN

Sponsor Role collaborator

University Medical Center Mainz

OTHER

Sponsor Role collaborator

Uniklinikum Giessen und Marburg

UNKNOWN

Sponsor Role collaborator

University Hospital Ulm

OTHER

Sponsor Role collaborator

Universitätsklinikum Leipzig

OTHER

Sponsor Role collaborator

University Hospital Regensburg

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Klaus Michael Beier

Director, Institute for Sexual Research and Sexual Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

+49 30450529301

Tillmann Krüger, Prof. Dr. med.

Role: CONTACT

+49 5115322470

References

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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

Reference Type 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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16141303 (View on PubMed)

Other Identifiers

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402913

Identifier Type: OTHER

Identifier Source: secondary_id

402913

Identifier Type: -

Identifier Source: org_study_id

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