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Cognitive AppRoaches to coMbatting Suicidality (CARMS)

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.
 
ClinicalTrials.gov Identifier: NCT03114917
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
Greater Manchester Mental Health NHS Foundation Trust
Lancaster University
Information provided by (Responsible Party):
Patricia Gooding, University of Manchester

Brief Summary:
This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment.

Condition or disease Intervention/treatment Phase
Psychosis Suicide Prevention Suicidality Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS) Not Applicable

Detailed Description:

Estimates show that around 6% of people with experiences of psychosis die by suicide. Many more think about it and attempt suicide. A meta-analysis by the investigators illustrated that psychological therapies are effective in reducing suicidal thoughts and acts in people with psychosis as long as those therapies target suicidal thoughts, intentions and plans, and not the reduction of symptoms of mental illnesses. Based on this work, we have designed a psychological cognitive "talking" therapy (called CARMS) to reduce suicidal thoughts in people with experiences of psychosis which targets the psychological processes thought to underpin the pathways to suicidal thoughts and behaviours. An increasing body of work shows that many people with psychosis experience social isolation, emotional dysregulation, and poor interpersonal problem-solving. These appraisals can then induce and intensify perceptions of being hopeless, trapped and defeated, which in turn leads to suicidal thoughts and acts. CARMS aims to help people find practical ways to change these sorts of perceptions. Two of the investigators' pilot randomised trials have demonstrated that CARMS is feasible and acceptable to people experiencing psychosis and may have the potential to be effective at reducing key suicide outcomes.

Hence, the investigators' next step is to test the efficacy of CARMS in the context of NHS mental health services and also to test whether the underlying psychological mechanisms on which CARMS is based are correct. The investigators will test CARMS using a medium sized randomised controlled trial (RCT), with two arms of CARMS plus treatment as usual versus just treatment as usual. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. The investigators will use both quantitative and qualitative methods and analyses to assess CARMS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised-controlled trial with a qualitative component.
Masking: Single (Outcomes Assessor)
Masking Description: All Research Assistants will be blinded to treatment allocation. The Research Assistants will be carrying out outcomes assessments at baseline, 6 month and 12 month.
Primary Purpose: Treatment
Official Title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CARMS therapy + TAU
Participants allocated to the CARMS therapy + TAU arm will receive their usual care and treatment from mental health services along with CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy. The CARMS therapy comprises of 24 sessions, each up to 50 minutes long over a 6 month period.
Other: Cognitive AppRoaches to coMbatting Suicidality (CARMS)
The investigators' psychological therapy is a recovery-focused, structured, time-limited, socio-cognitive intervention. It is based upon the investigators' recently developed treatment manual (Tarrier et al., 2013) and pilot RCTs in the community (Tarrier et al., 2014) and in prison (Tarrier et al., accepted). The intervention modifies negative appraisals of emotional regulation, social support, and interpersonal problem-solving. As a consequence, perceptions of defeat, entrapment, and hopelessness will be improved indirectly. In addition, perceptions of defeat, entrapment, and hopelessness will be worked on directly during the therapy.

No Intervention: TAU
Participants allocated to treatment as usual (TAU) will receive their usual care and treatment from mental health services.



Primary Outcome Measures :
  1. Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Suicidal ideation valid measure


Secondary Outcome Measures :
  1. Change from Baseline Suicide Probability Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Suicide risk valid measure

  2. Change from Baseline Beck Scale for Suicidal ideation score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Assess an individual's thoughts, attitudes and intentions regarding suicide

  3. Change from Baseline Frequency of suicidal thoughts, plans and acts at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to ascertain frequency of suicidal thoughts, plans and acts across six months

  4. Change from Baseline Frequency of Suicide Attempts at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Frequency of suicide attempts will be collected from medical records


Other Outcome Measures:
  1. Change from Baseline Difficulties in Emotional Regulation Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures emotional dysregulation

  2. Change from Baseline Social Problem-Solving Inventory score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures individual's social problem-solving skills

  3. Change from Baseline Social Support Appraisals Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures individual's appraisals of social support

  4. Change from Baseline Beck Hopelessness Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations

  5. Change from Baseline Defeat and Entrapment scale scores at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures how defeated and trapped individuals feel respectively

  6. Change from Baseline Positive and Negative Syndrome Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to assess symptom severity of individual's experiencing Schizophrenia

  7. Change from Baseline Psychotic Symptoms Ratings Scale (PSYRATS) score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to assess symptoms of psychosis

  8. Change from Baseline Personal and Social Performance Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to assess personal and social functioning in individual's experiencing Schizophrenia

  9. Change from Baseline Calgary Depression Scale score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to assess symptoms of depression in individual's experiencing Schizophrenia

  10. Change from Baseline Frequency and Type of Substance Misuse as measured by the Timeline Follow Back at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Clinical interview to ascertain frequency and type of substance misuse over 3 months

  11. Change from Baseline Drug use (self-reported) DAST score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Measure which identifies drug 'abuse'

  12. Change from Baseline Alcohol use (self-reported) AUDIT score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Gold standard measure which identifies alcohol use

  13. Change from Baseline Reasons for substance Use Scale - Alcohol and Drugs scores at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    Questionnaire measure which identifies individual's reasons for using alcohol and drugs respectively

  14. Change from Baseline Sleep Condition Indicator score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measures insomnia

  15. Current medication for mental health problems as prescribed at baseline assessment time point [ Time Frame: Baseline ]
    Information regarding which anti-psychotic medication, if the medication is atypical, and the dosage will be collected from medical records

  16. Change from Baseline Working Alliance Inventory - short form score at 6 and 12 months [ Time Frame: Baseline, 6 month and 12 month follow up ]
    The questionnaire measure the client-therapist therapeutic alliance from the participant's and the therapist's perspective

  17. Change from Baseline EQ-5D score at 12 months [ Time Frame: Baseline and 12 month follow up ]
    The questionnaire measures health outcomes

  18. Change from Baseline Client Service Use Receipt Inventory at 12 months [ Time Frame: Baseline and 12 month follow up ]
    The questionnaire measures use of services



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • ICD-10 diagnosis of psychosis (i.e. F20 - F29)
  • suicidal thoughts and/or acts in the past three months
  • in contact with mental health services and under the care of a mental health services clinical team (i.e., community or inpatient mental health care teams) with a care coordinator
  • aged 18 or over
  • English-speaking (hence, not needing an interpreter)
  • able to give informed consent as assessed by either a responsible clinician or by trial RAs following the British Psychological Society's guidelines on gaining informed consent (http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf)

Exclusion Criteria:

  • dementia, or an organic brain disorder
  • unable to complete assessments due to language barriers
  • currently taking part in a clinical trial.

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 ClinicalTrials.gov identifier (NCT number): NCT03114917


Locations
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United Kingdom
Pennine Care NHS Foundation Trust
Ashton under Lyne, United Kingdom
Lancashire Care NHS Foundation Trust
Chorley, United Kingdom
Greater Manchester Mental Health NHS Trust
Manchester, United Kingdom, M13 9WL
Northwest Boroughs Healthcare NHS Foundation Trust
Warrington, United Kingdom
Sponsors and Collaborators
University of Manchester
Greater Manchester Mental Health NHS Foundation Trust
Lancaster University
Investigators
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Principal Investigator: Patricia Gooding University of Manchester
Principal Investigator: Gillian Haddock University of Manchester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patricia Gooding, Senior Lecturer, University of Manchester
ClinicalTrials.gov Identifier: NCT03114917    
Other Study ID Numbers: 13/161/25
220 ( Other Identifier: Greater Manchester Mental Health NHS Foundation Trust )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators are undecided at present.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Gooding, University of Manchester:
Suicide
Self-harm
Psychosis
Community
Suicide Prevention
CBT
CARMS
Randomised controlled trial
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Suicide
Schizophrenia Spectrum and Other Psychotic Disorders
Self-Injurious Behavior
Behavioral Symptoms