Contact information
Type
Scientific
Primary contact
Dr Lesley Maunder
ORCID ID
Contact details
Northumberland
Tyne & Wear NHS Trust
St George's Park
Morpeth
NE61 2NU
United Kingdom
+44 01670 501745
lesley.maunder@nmht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0682184267
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
HADS
Secondary outcome measures
Not provided at time of registration
Overall trial start date
29/07/2006
Overall trial end date
28/02/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Prisoners with symptoms of anxiety and/or depression.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
29/07/2006
Recruitment end date
28/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northumberland, Tyne & Wear NHS Trust
Morpeth
NE61 2NU
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northumberland Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.mendeley.com/research/effectiveness-of-selfhelp-materials-for-anxiety-adapted-for-use-in-prison-a-pilot-study/