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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Lesley Maunder
Scientific

Northumberland, Tyne & Wear NHS Trust
St George's Park
Morpeth
NE61 2NU
United Kingdom

Phone	+44 01670 501745
Email	lesley.maunder@nmht.nhs.uk

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

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

Northumberland, Tyne & Wear NHS Trust

Morpeth
NE61 2NU
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Northumberland Care Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/08/2009		Yes	No

24/01/2023: The study setting has been changed from ‘Hospital’ to 'Prison/detention'.