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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Paedophilia; Hebephilia
• Intervention / Treatment: Behavioral: Psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Michael Beier, Prof. Dr. med. Dr. phil.; Phone Number: +49 30450529301; Email: klaus.beier@charite.de
• Study Contact Backup: Name: Tillmann Krüger, Prof. Dr. med.; Phone Number: +49 5115322470; Email: krueger.tillmann@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; This group receives treatment	Behavioral: Psychotherapy; Psychotherapy according to the Berlin Dissexuality Therapy (BEDIT)
No Intervention: Waitlist Control-group; This group consists of individuals randomized to the waitlist condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence	Abstinence rates for the consumption of abusive images	From enrollment to the end of treatment 12 - 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of abstinence rates	Frequency of abstinence rates for the use of child abuse images	From enrollment to the end of treatment 12 - 18 weeks
Sexual preoccupation	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)	From enrollment to the end of treatment 12 - 18 weeks
Cognitive distortions about child sexual abuse	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)	From enrollment to the end of treatment 12 - 18 weeks
Emotion regulation	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	From enrollment to the end of treatment 12 - 18 weeks
Mental Health	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	From enrollment to the end of treatment 12 - 18 weeks
General well-being	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	From enrollment to the end of treatment 12 - 18 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Hannover Medical School; Heinrich-Heine University, Duesseldorf; Universitätsklinikum Hamburg-Eppendorf; University Hospital Ulm; University Hospital Regensburg; Universitätsklinikum Leipzig; Klinikum Bamberg; University Medical Center Mainz; Universitätsklinikum Kiel; Uniklinikum Giessen und Marburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Sexual Offending; Paedophilia; Hebephilia; Child Abuse Images
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Pedophilia
• Other Study ID Numbers: 402913 (Other Identifier: ChariteU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No