ComorbidityPhase 1/2ENGAGENCT00980824
ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients
A Phase 1/2 study testing Cognitive behavioural therapy and Standard treatment in people with Comorbidity and Substance Abuse, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidity, Substance Abuse, Personality Disorder
- What is being tested?
- Cognitive behavioural therapy and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Nov 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- unable to give written informed consent
- unable to understand the purpose and nature of the research
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, Lanarkshire, G12 0XH
Kate Davidson, PhD, +44 141 211 3900, k.davidson@clinmed.gla.ac.uk
Brown Tom, MBChB
About this study
Official title: 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.
Read the 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.
- Conditions
- Comorbidity, Substance Abuse, Personality Disorder
- Being tested
- Cognitive behavioural therapy, Standard treatment
- Keywords
- cognitive behaviour therapy, self harm, personality disorder, complex comorbidity, mental health
- Medical subject headings
- Substance-Related Disorders, Personality Disorders, Self-Injurious Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
Six sessions brief CBT.
Standard treatmentOther
Referral to NHS services appropriate to patient's needs
| Study group | Role | What they receive |
|---|---|---|
| therapy | Experimental | Cognitive behavioural therapy. Six sessions of structured focused therapy. Receives: Behavioral: Cognitive behavioural therapy |
| Standard treatment | Active comparator | referral to specialised or generic mental health service Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of contacts with mental health services appropriate to the patient's needs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Investigators
- Kate M Davidson, PhD, Principal investigator, University of Glasgow/NHS Greater Glasgow & Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980824
- Sponsor's protocol ID
- 62060
- Acronym
- ENGAGE
- Status last verified
- Jun 2010
- First submitted
- 18 Sep 2009
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGAGE - Meeting Mental Health Needs of Complex Comorbid Patients Attending A&E Following a Suicide Attempt. A Pilot Study.
- ClinicalTrials.gov ID
- NCT00980824
- Acronym / sponsor ID
- ENGAGE / 62060
- Conditions
- Comorbidity, Substance Abuse, Personality Disorder
- Keywords
- cognitive behaviour therapy, self harm, personality disorder, complex comorbidity, mental health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapy | Experimental | Behavioral: Cognitive behavioural therapyCognitive behavioural therapy. Six sessions of structured focused therapy. |
| Standard treatment | Active comparator | Other: Standard treatmentreferral to specialised or generic mental health service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- unable to give written informed consent
- unable to understand the purpose and nature of the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapySix sessions brief CBT. | Behavioural | therapy |
| Standard treatmentReferral to NHS services appropriate to patient's needs | Other | Standard treatment |
Primary outcome
The number of contacts with mental health services appropriate to the patient's needs.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
- Derived from this study: PubMed 33884617Witt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate M Davidson, PhD principal investigator
University of Glasgow/NHS Greater Glasgow & Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive behavioural therapy and Standard treatment in people with Comorbidity and Substance Abuse, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate M Davidson, PhD (+441412113900, k.davidson@clinmed.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of contacts with mental health services appropriate to the patient's needs. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2010.