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 |
| Secondary identifying numbers | MRD 12/92 |
- 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
Not provided at time of registration
Contact information
Prof Don Grubin
Scientific
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
| Study design | HSF: Randomised, open controlled parallel study. SSRI: Randomised, double-blind, placebo-controlled parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Prison/detention |
| Study type | Treatment |
| 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure | The multiphasic sex inventory - sexual obsessions sub-scale |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2006 |
| Overall study end date | 01/09/2009 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 240 in each evaluation (maximum 480 participants) |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/09/2006 |
| Recruitment end date | 01/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Newcastle
Newcastle-upon-Tyne
NE3 4ES
United Kingdom
NE3 4ES
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
c/o Ms Kay Pattison
Section Head National Health Service (NHS) Research and Development Programmes
University of Liverpool
Health and Community Care Research Unit (HaCCRU)
Thompson-Yates Building
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
"ROR" |
https://ror.org/03sbpja79 |
|---|
Funders
Funder type
Government
National Forensic Mental Health Research and Development Programme, reference number: MRD 12/92, http://www.nfmhp.org.uk/ (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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’.
