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

ISRCTN	ISRCTN09267489
DOI	https://doi.org/10.1186/ISRCTN09267489
Protocol serial number	MRD 12/92
Sponsor	Department of Health (UK)
Funder	National Forensic Mental Health Research and Development Programme, reference number: MRD 12/92, http://www.nfmhp.org.uk/ (UK)

Submission date: 24/04/2006
Registration date: 07/06/2006
Last edited: 24/01/2023

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Don Grubin
Scientific

University of Newcastle
North Tyneside and Northumberland Mental Health Trust
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle-upon-Tyne
NE3 4ES
United Kingdom

Study information

Primary study design	Interventional
Study design	HSF: Randomised, open controlled parallel study. SSRI: Randomised, double-blind, placebo-controlled parallel study
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	HSF-SSRI
Study objectives	To determine whether either the healthy sexual functioning (HSF) module of the sex offenders treatment programme or selective serotonin reuptake inhibitor (SSRI) medication have a positive impact on relevant psychological mechanisms associated with sexual offending
Ethics approval(s)	Approved by South East MultiCentre Research Ethics Committee, Kent on 18/10/2005, reference number: 05/MRE01/82
Health condition(s) or problem(s) studied	Deviant sexual arousal
Intervention	HSF evaluation: consenting eligible subjects will be randomised to either treatment with the HSF module (receiving treatment in the next available treatment slot) or a waiting list control group (receiving HSF treatment after study assessments have been completed). SSRI evaluation: consenting eligible subjects will be randomised to either fluoxetine or placebo for a period of 20-26 weeks (the randomisation will be balanced for allocated group in the HSF evaluation, if consent is given for this evaluation also). Added 05/02/10: trial stopped by 2007 because of recruitment problems.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluoxetine
Primary outcome measure(s)	The multiphasic sex inventory - sexual obsessions sub-scale
Key secondary outcome measure(s)	HSF: penile plethysmography and impulsivity scale (sex offender treatment programme) SSRI only: 1. Fantasy visual analogue scale 2. Sexual outlet inventory 3. Yale-brown obsessive-compulsive scale 4. Hospital anxiety and depression scale 5. Mood visual analogue scale and Udvalg for Kliniske Undersogelser (UKU) side effect rating
Completion date	01/09/2009
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	480
Key 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)
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Newcastle

Newcastle-upon-Tyne
NE3 4ES
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Editorial Notes

24/01/2023: The study setting has been updated from ‘Not specified’.