A randomised controlled trial to investigate the effectiveness of the healthy sexual functioning module and selective serotonin reuptake inhibitor medication to treat deviant sexual arousal as part of the HM prison sex offender treatment programme

Not Applicable

• Conditions: Deviant sexual arousal; Mental and Behavioural Disorders; Sex offender

• Registration Number: ISRCTN09267489
• Lead Sponsor: Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-07
• Study Completion: 2009-09-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Stopped
• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

Consent to treatment in HSF module of HM prison sex offender treatment programme with written informed consent.

In addition, for SSRI sub-study, any one of the following:
1. Sexual preoccupation (either from clinical assessment or based on the multiphasic sex inventory [MSI] obsession scale)
2. A compulsive aspect to their offending (based on clinical judgement)
3. Mood state being an important contributor to their offending (based on clinical judgement)
4. Impulsivity (based on clinical judgement or impulsivity score)

Exclusion Criteria

HSF evaluation: urgent treatment need as assessed by the treatment manager

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The multiphasic sex inventory - sexual obsessions sub-scale

Secondary Outcome Measures

Name	Time	Method
<br> HSF: penile plethysmography and impulsivity scale (sex offender treatment programme)<br><br> SSRI only:<br> 1. Fantasy visual analogue scale<br> 2. Sexual outlet inventory<br> 3. Yale-brown obsessive-compulsive scale<br> 4. Hospital anxiety and depression scale<br> 5. Mood visual analogue scale and Udvalg for Kliniske Undersogelser (UKU) side effect rating<br>