A Randomised Controlled Trial to Investigate the effectiveness of the Healthy Sexual Functioning (HSF) Module and Selective Serotonin Reuptake Inhibitor (SSRI) Medication to treat Deviant Sexual Arousal as part of the HM Prison Sex Offender Treatment Programme. - HSF-SSRI Trial

Phase 1

• Conditions: Deviant Sexual Arousal (sex offender); MedDRA version: 8.1Level: LLTClassification code 10063494Term: Sexual offence

• Registration Number: EUCTR2005-003435-40-GB
• Lead Sponsor: Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

HSF evaluation:
• Consent to treatment in HSF module of HM Prison sex offender treatment programme
• Written informed consent for HSF evaluation

SSRI evaluation:
• Consent to treatment in HSF module of HM Prison sex offender treatment programme
• Written informed consent for SSRI evaluation
And any one of the following:
• sexual preoccupation (clinical assessment from SARN or based on the MSI Obsession scale);
• a compulsive aspect to their offending (clinical assessment from SARN);
• mood state being an important contributor to their offending (clinical assessment from SARN);
• impulsivity (clinical assessment from SARN or impulsivity score)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

HSF evaluation:
• Urgent treatment need as assessed by the treatment manager

SSRI evaluation:
• Presence of psychotic disorder or major mood disorder; epilepsy; uncontrolled seizure disorders; diabetes; major cardiac problems; severe renal failure
• Concomitant treatment with psychoactive medication which may interact with the effects of the SSRI e.g. neuroleptic or antidepressant medication
• Concomitant treatment with an anti-androgen
• Concomitant treatment with an anti-coagulant
• Current treatment, or treatment within the last 4 weeks with a SSRI
• Previous adverse reaction to a SSRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether either the HSF module of the Sex Offenders Treatment Programme or SRRI medication have a positive impact on relevant psychological mechanisms associated with sexual offending.;Secondary Objective: To determine whether either the HSF module of the Sex Offenders Treatment Programme or SSRI medication have a positive impact on: <br><br>Relevant physiological mechanisms associated with sexual offending;<br>Obsessive compulsive phenomena, mood and impulsivity;<br>Sexual re-offending (not demonstrated within proposed study period but within the HM PRison Service Offending Behaviour programmes Unit research plan).;Primary end point(s): The primary outcome variable is the impact of HSF or SSRI treatment on relevant psychological mechanisms associated with sexual offending, measured using the Multiphasic Sex Inventory Sex Obsession Subscale.