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Cognitive and Hormonal Treatment of Sex Offenders

This study has been terminated.
(too few patients participated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379626
First Posted: September 22, 2006
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

Condition Intervention Phase
Paraphilia Drug: cognitive and hormone treatment Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Group and Hormonal Treatment of Sex Offenders.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • The degree of cognitive distortions after treatment [ Time Frame: 8 months ]

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


Enrollment: 5
Actual Study Start Date: August 2003
Study Completion Date: August 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) treatment
Drug: cognitive and hormone treatment
cognitive and hormone (Leuprorelin) 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Men sentenced for paraphilia

Exclusion Criteria:

Men above 70 years and men that does not speak english

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379626


Locations
Norway
St. Olavs Hospital. Departement for forensic psyciatry, Brøset.
Trondheim, Norway, 7040
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Jim Aa Nøttestad, Dr. Philos St. Olavs Hospital, Departement of forensic psychiatry, Brøset
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00379626     History of Changes
Other Study ID Numbers: AH 048-01
First Submitted: September 21, 2006
First Posted: September 22, 2006
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Norwegian University of Science and Technology:
Paraphilia
Hormonal treatment
Cognitive treatment

Additional relevant MeSH terms:
Paraphilic Disorders
Mental Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs