Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/04/2015
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 Sean Lynch

ORCID ID

Contact details

The Department of Mental Health
University of Exeter
Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0079153958

Study information

Scientific title

A pilot study to evaluate a Guided Self-Help Programme for people who have self harmed and a follow up study of patients who have participated in Exeter GUS 1.1

Acronym

Study hypothesis

To assess whether guided self help (GSH) in addition to standard care, has the potential to improve mood systems, hopelessness and social function compared to standard care alone.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Self harm

Intervention

Guided self help (GSH) in addition to standard care compared to standard care alone.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Assess the potential effect size of intervention on mood and suicide risk and social function.
Measures: HAD anxiety and depression scale, Beck Hopelessness Scale, Beck suicidal intent scale. Social function questionnaire - all at 0 weeks, 2-4 weeks, and 6 weeks.

Secondary outcome measures

Patient satisfaction questionnaire at end of study and coping strategy questionnaire at beginning and end of study.

Overall trial start date

02/03/2004

Overall trial end date

02/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive attendances at R&D of patients aged 16-65 years who have self harmed and are not thought to require immediate medical attention or have severe mental illness affecting their ability to consent to research or of imminent and serious suicide risk.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25 patients - 2 groups

Participant exclusion criteria

1. Children under the age of 16
2. Patients of no fixed abode, not resident in Devon, not contactable by telephone
3. Serious mental health problem or suicide risk requiring urgent admission

Recruitment start date

02/03/2004

Recruitment end date

02/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Exeter
Exeter
EX2 5AF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Devon Partnership NHS Trust (UK), NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes