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

September 18, 2024 updated by: Klaus Michael Beier, Charite University, Berlin, Germany

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Klaus Michael Beier, Prof. Dr. med. Dr. phil.
  • Phone Number: +49 30450529301
  • Email: klaus.beier@charite.de

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: From enrollment to the end of treatment 12 - 18 weeks
Abstinence rates for the consumption of abusive images
From enrollment to the end of treatment 12 - 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment 12 - 18 weeks
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)
From enrollment to the end of treatment 12 - 18 weeks
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)
From enrollment to the end of treatment 12 - 18 weeks
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
From enrollment to the end of treatment 12 - 18 weeks
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
From enrollment to the end of treatment 12 - 18 weeks
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
From enrollment to the end of treatment 12 - 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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