Efficacy of self-help materials for anxiety and depression specifically adapted for use in prison: a pilot study
| ISRCTN | ISRCTN54760645 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54760645 | 
| Secondary identifying numbers | N0682184267 | 
- Submission date
 - 28/09/2007
 - Registration date
 - 28/09/2007
 - Last edited
 - 24/01/2023
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Mental and Behavioural Disorders
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Lesley Maunder
Scientific
                                        Scientific
                                                Northumberland, Tyne & Wear NHS Trust
St George's Park
Morpeth
NE61 2NU
United Kingdom
                                                
| Phone | +44 01670 501745 | 
|---|---|
| lesley.maunder@nmht.nhs.uk | 
Study information
| Study design | Randomised controlled pilot study | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Prison/detention | 
| Study type | Prevention | 
| Scientific title | Efficacy of self-help materials for anxiety and depression specifically adapted for use in prison: a pilot study | 
| Study objectives | What is the response of prisoners with anxiety and/or depression to written self-help materials for mental health compared to usual treatment? This is in terms of symptom response and the prisoners attitudes to the self-help materials. | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Depression | 
| Intervention | Prisoners that are eligible and accept their invite to participate will return to healthcare a week later to sign a consent form. The HADS (primary outcome measure) will determine allocation to either the depression or anxiety group (if scores are equivalent a simple question will be asked and ultimately depression will have priority (NICE, 2000). Within these groups blocked randomisation will determine if they are in the intervention (receive self-help) or control (delayed intervention) group. All participants will receive treatment as usual. | 
| Intervention type | Other | 
| Primary outcome measure | HADS | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 29/07/2006 | 
| Completion date | 28/02/2007 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Male | 
| Target number of participants | Not provided at time of registration | 
| Key inclusion criteria | Prisoners with symptoms of anxiety and/or depression. | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 29/07/2006 | 
| Date of final enrolment | 28/02/2007 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            Northumberland, Tyne & Wear NHS Trust
                                        
                                        
                                            
                                            Morpeth
NE61 2NU
United Kingdom
                                    NE61 2NU
United Kingdom
Sponsor information
                                            Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
                                        Government
                                                The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Phone | +44 (0)20 7307 2622 | 
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en | 
Funders
Funder type
Government
                                                Northumberland Care Trust (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 | 
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? | 
|---|---|---|---|---|---|
| Results article | results | 13/08/2009 | Yes | No | 
Editorial Notes
24/01/2023: The study setting has been changed from ‘Hospital’ to 'Prison/detention'.