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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980824
Recruitment Status : Unknown
Verified June 2010 by University of Glasgow.
Recruitment status was:  Recruiting
First Posted : September 21, 2009
Last Update Posted : June 28, 2010
NHS Greater Glasgow and Clyde
Information provided by:
University of Glasgow

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Comorbidity Substance Abuse Personality Disorder Behavioral: Cognitive behavioural therapy Other: Standard treatment Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients Attending A&E Following a Suicide Attempt. A Pilot Study.
Study Start Date : November 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. The number of contacts with mental health services appropriate to the patient's needs. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980824

Contact: Kate M Davidson, PhD +441412113900
Contact: Tom Brown, MPhil +441412112131

United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0XH
Contact: Kate Davidson, PhD    +44 141 211 3900   
Principal Investigator: Brown Tom, MBChB         
Principal Investigator: Kate Davidson, PhD         
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde
Principal Investigator: Kate M Davidson, PhD University of Glasgow/NHS Greater Glasgow & Clyde

Responsible Party: University of Glasgow Identifier: NCT00980824     History of Changes
Other Study ID Numbers: 62060
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010

Keywords provided by University of Glasgow:
cognitive behaviour therapy
self harm
personality disorder
complex comorbidity
mental health

Additional relevant MeSH terms:
Substance-Related Disorders
Personality Disorders
Chemically-Induced Disorders
Mental Disorders