Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
13/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2009 results in http://www.mendeley.com/research/effectiveness-of-selfhelp-materials-for-anxiety-adapted-for-use-in-prison-a-pilot-study/

Publication citations

Additional files

Editorial Notes