Cognitive and Hormonal Treatment of Sex Offenders

February 13, 2017 updated by: Norwegian University of Science and Technology

Cognitive Group and Hormonal Treatment of Sex Offenders.

The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual thoughts after treatment with Leuprorelin. The study is an open pre and post study.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Norway
      • Trondheim, Norway, 7040
        • St. Olavs Hospital. Departement for forensic psyciatry, Brøset.

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Men sentenced for paraphilia

Exclusion Criteria:

Men above 70 years and men that does not speak english

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) treatment
Drug: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of cognitive distortions after treatment
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locus of control after treatment in part one.
Time Frame: 8 months
8 months
Degree of mental health problems (SCL-90)
Time Frame: 8 months
8 months
The testosterone levels before, during and after treatment
Time Frame: baseline upto 8 months
measured each 3rd month
baseline upto 8 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Jim Aa Nøttestad, Dr. Philos, St. Olavs Hospital, Departement of forensic psychiatry, Brøset

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 (Actual)

August 1, 2003

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (Estimate)

September 22, 2006

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH 048-01

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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