ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients (ENGAGE)

June 25, 2010 updated by: University of Glasgow

ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients Attending A&E Following a Suicide Attempt. A Pilot Study.

Scotland has higher rates of suicide than other parts of the UK, an average rate of 15.1 per 100,000 in Scotland compared to 11.4 for England and Wales. The Scottish Government is committed to reducing suicide by 2013. Choose Life has led to staff in services such as Accident and Emergency (A&E) receiving recent training in suicide prevention through ASIST and STORM.

Evidence for interventions specific to A&E setting is limited despite the fact that this is the most likely point of first contact with health services for people at risk of this behaviour. Brief interventions that reduce repetition of self harm have not been particularly effective partly because of poor attendance and lack of focus on comorbidity. We propose to pilot an evaluation of a brief focused intervention, ENGAGE (based on MAnualised Cognitive Therapy,MACT, developed by the investigator (Kate Davidson) and Prof Ulrike Schmidt of the Institute of Psychiatry, London) for those who present at A&E with a suicide attempt and who have a complex presentation - a combination of substance abuse and or personality disorder, all of which are recognized as high risk factors for suicide. ENGAGE will specifically encourage patients to seek appropriate services to meet their mental health needs. This pilot will allow us to assess the feasibility of a full scale study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an exploratory single centre, randomised controlled trial of a complex intervention based on cognitive behavioural therapy principles for patients with a recent episode of suicide and who have personality disorder/s and or substance abuse (complex comorbidity). Patients who join the study will be randomly allocated to receive either ENGAGE CBT or Treatment as Usual (TAU). We will compare the effectiveness of ENGAGE with TAU. The primary outcome will be engagement with services - the number of contacts with mental health services (e.g. drug, alcohol and CMHT) in the 3 months following the participant's randomisation.

We will recruit 30 patients seen in the hospital by the Liaison Team with a suicide attempt who score above the threshold for personality disorder and drug or alcohol abuse using SAPAS,AUDIT and DAST assessments. If the patient is interested in the study a research assistant will obtain consent and conduct a baseline interview at which full personality disorder diagnostic status will be confirmed and further psychological measures will be taken. The patient will be randomised to ENGAGE (CBT) or TAU and interviewed again by the research assistant at 3 months post randomisation. The research assistant will be blind to treatment group. Those patients randomised to ENGAGE CBT will receive 6 sessions of the intervention from a CBT therapist. ENGAGE will help patients to identify problems, use problem solving to help prioritise and resolve problems and motivate patients to attend the treatment recommended by the liaison team. The ENGAGE therapist will encourage and, if necessary, facilitate patients with substance abuse and personality disorder to engage in the appropriate NHS services.

TAU - usual treatment is the services that patients may already be involved in or services that the patient has been referred to following the suicide episode.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0XH
        • Recruiting
        • NHS Greater Glasgow and Clyde
        • Contact:
        • Principal Investigator:
          • Brown Tom, MBChB
        • Principal Investigator:
          • Kate Davidson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients will have had an episode of deliberate self harm
  • test positive on either Drug Abuse Screening Test (DAST, Skinner 1982) or Alcohol Use Disorders Identification Test (AUDIT, Saunders 1983)

Exclusion Criteria:

  • unable to give written informed consent
  • unable to understand the purpose and nature of the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: therapy
Cognitive behavioural therapy. Six sessions of structured focused therapy.
Behavioral: Cognitive behavioural therapy
Six sessions brief CBT.
Active Comparator: Standard treatment
referral to specialised or generic mental health service
Other: Standard treatment
Referral to NHS services appropriate to patient's needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of contacts with mental health services appropriate to the patient's needs.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Kate M Davidson, PhD, University of Glasgow/NHS Greater Glasgow & Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 28, 2010

Last Update Submitted That Met QC Criteria

June 25, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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