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

Primary Purpose

Comorbidity, Substance Abuse, Personality Disorder

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Standard treatment
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Comorbidity focused on measuring cognitive behaviour therapy, self harm, personality disorder, complex comorbidity, mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Greater Glasgow and ClydeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

therapy

Standard treatment

Arm Description

Cognitive behavioural therapy. Six sessions of structured focused therapy.

referral to specialised or generic mental health service

Outcomes

Primary Outcome Measures

The number of contacts with mental health services appropriate to the patient's needs.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2009
Last Updated
June 25, 2010
Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT00980824
Brief Title
ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients
Acronym
ENGAGE
Official Title
ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients Attending A&E Following a Suicide Attempt. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comorbidity, Substance Abuse, Personality Disorder
Keywords
cognitive behaviour therapy, self harm, personality disorder, complex comorbidity, mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
therapy
Arm Type
Experimental
Arm Description
Cognitive behavioural therapy. Six sessions of structured focused therapy.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
referral to specialised or generic mental health service
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
Six sessions brief CBT.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
Referral to NHS services appropriate to patient's needs
Primary Outcome Measure Information:
Title
The number of contacts with mental health services appropriate to the patient's needs.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate M Davidson, PhD
Phone
+441412113900
Email
k.davidson@clinmed.gla.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Brown, MPhil
Phone
+441412112131
Email
tom.brown@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate M Davidson, PhD
Organizational Affiliation
University of Glasgow/NHS Greater Glasgow & Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Davidson, PhD
Phone
+44 141 211 3900
Email
k.davidson@clinmed.gla.ac.uk
First Name & Middle Initial & Last Name & Degree
Brown Tom, MBChB
First Name & Middle Initial & Last Name & Degree
Kate Davidson, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived

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ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients

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