CARMS v1
Research type
Research Study
Full title
A psychological intervention for suicide applied to patients with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)
IRAS ID
201644
Contact name
Patricia Gooding
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Background to the proposed research? Around 6% of people with psychosis die by suicide. Many more think about suicide. Talking therapies for people with psychosis focus on symptoms which does not stop people from having suicidal thoughts or making suicide attempts. We have designed a psychological therapy (called CARMS, Cognitive AppRoaches to coMbatting Suicidality) which specifically targets suicidal thoughts and behaviours. Many people with psychosis feel isolated, unable to cope emotionally, nor able to deal with their problems. Feelings of being hopeless, trapped and defeated may ensue which are precursors to suicidality. CARMS aims to help people find ways of dealing with these sorts of negative perceptions and feelings. \nWhat are the research questions? Is CARMS effective in reducing suicidal thoughts and behaviours in people experiencing psychosis? Are the postulated psychological mechanisms on which CARMS is based correct? How well does CARMS work in practice in the NHS?\nHow does this research answer these questions? We propose a two-armed (treatment versus control) randomised controlled trial (RCT) comparing two groups, each of 125 participants with psychosis and recent experiences of suicidal ideation and/or behaviours. The control group will receive their usual treatment. The treatment group will be offered up to 24 weekly sessions of CARMS therapy, plus their usual treatment. We will take assessments of i. suicidal thoughts and behaviours, ii. appraisals of social isolation, emotion dysregulation, and problem solving, and iii. perceptions of being defeated, trapped, and hopeless at three time-points , namely, baseline, 6 and 12 months. The RCT will also involve qualitative work probing psychological mechanisms and the effectiveness of our CARMS therapy. \nHow and where will the research be carried out? The Universities of Manchester and Lancaster will work with 4 NHS trusts in the Northwest. The study will take 4 years, (commencing 01-01-17). [COVID 19 amendment 01/05/2020] 1. CARMS Trial Protocol In light of the current COVID-19 outbreak, the CARMS team wish to assess and explore the impact of COVID-19 on participants who are taking part in CARMS (i.e. people with psychosis and suicidal thoughts and/or behaviour).\nFurthermore, the CARMS team have discussed analytical implications of the COVID-19 outbreak, e.g. internal and\nexternal validity of current outcome measures. One component of the current trial is to assess the psychological\nmechanisms which the Schematic Appraisal Model for Suicidality (SAMS) suggest underlie suicidal thoughts and\nbehaviours. Specific mechanisms of interest are appraisals of emotion regulation, social support and inter-personal\nproblem solving. Such psychological processes may be affected by the government restrictions placed during the\nCOVID-19 outbreak, along with COVID-19 itself, which may in turn affect suicidal thoughts and behaviours differently\nto usual circumstances. Therefore, to account for this, the CARMS team have several proposals to both mitigate\nagainst the potential effect on internal and external validity of current outcome measures and assess the impact of\nCOVID-19 on participants who are taking part in CARMS. i. (A13, A18) To add three questions to the clinical interviews and therapy processes data collection to ascertain\nwhether participants have symptoms of COVID-19, if they are self-isolating and the specific reason they are selfisolating. ii. (A13, A18) To add a short quantitative scale, namely, the Impact of Events Scale Revised (IES-R; Weiss & Marmar,\n1997). The IES-R scale is designed to measure personal distress experienced over the last 7 days in relation to a\nspecific traumatic life event. The IES-R has previously been used to examine PTSD symptoms during the SARS\noutbreak (Reynolds et al., 2008) and so could be adapted for the COVID-19 outbreak.\niii. (A13, A18) To add an appendix to the topic guide which examines the effects of taking part in suicide research.\niv. (A13, A18) To collect two sets of scores for current clinical interview measures (PANSS, PSYRATS, PSP, TLFB for\nsuicide and TLFB for substance use) and primary outcome measure (ASIQ), e.g. actual thoughts and feelings vs what people would be feeling if COVID-19 was not present.\nv.(A19) To collect COVID-19 related therapy process data, e.g. number of minutes spent discussing COVID-19 related\nissues during therapy.\nvi. (A30-1, A30-2) The proposal is to adapt the process for gaining informed consent during the COVID-19 outbreak.\nRecent guidance set out by both the government and Greater Manchester Mental Health NHS Foundation Trust in light of the COVID-19 outbreak, has advised that face to face contact with participants to be suspended. As such, researchers will seek to gain informed consent by either a. email, b. postal service, c. text message or d. audio recording verbal consent. Researchers will ask which method of consent potential participants would be comfortable\nwith, then seek to obtain informed consent via the chosen method:\na. Email: The potential participant would be emailed the consent form using NHS or university email addresses. The researchers will go through the consent form by phone and if the potential participant agrees to take part, they will fill the consent form in and send it back to the researcher by email.\nb. Postal service: The potential participant would be sent a physical consent form by post, along with a stamped and addressed envelope for them to return the consent form to an NHS building (and/or University when the buildings reopen).\nThe researchers will go through the consent form by phone and if the potential participant agrees to take part, they will fill the consent form in and send it back to the researcher in the stamped and addressed envelope.\nc. Text message: The researchers will go through the consent form by phone and if the potential participant agrees to take part, they will send a text to the researcher with confirmation of which items of the consent form they agree to.\nThe researcher will then take a screenshot of the text message to store on the NHS and/or University secure servers/drives.\nd. Audio recording verbal consent: The researchers will firstly seek verbal confirmation that the participant agrees to verbal informed consent being audio recorded. If the participant agrees to be audio recorded, then the researcher can press record on the audio recording device and go through the consent form over the phone with the potential participant. The research will ask the potential participant to state if they agree or disagree to each item of the consent form. Note that files for all electronic methods of obtaining informed consent (email, text message and audio recording) will\nbe stored on the NHS and/or University secure servers/drives separate to the anonymised research data.\nFor participants who chose to consent to take part in the CARMS study via email and text, we will collect hard copies\nof consent forms at their 6 or 12 month follow up appointment. If the study team are unable to obtain hard copies (e.g.\ndue to withdrawal, lost to follow up or if the lockdown restrictions had not lifted by the point of the participant’s 12\nmonth follow up appointment), email addresses and/or mobile phone numbers will be retained for 15 to 20 years to\nshow that the participant provided informed consent from their email address and/or mobile phone. Such retention\nperiod is in line with the current retention period for hard copies consent forms and audio recordings.\nvii. Key contacts have been updated and some typos have been corrected.\n2. PIS 1 Appendix 4\n(A34) An appendix to PIS 1 has been created in light of the protocol change to examine the impact of COVID-19 on participants who are taking part in CARMS. It ensures that participants are informed that CARMS are collecting information from them related to the impact of COVID-19 and that such information will be analysed. Information on PIS 1 Appendix 4 will be explained verbally and, wherever possible, sent via email and/or post.\n3. Consent form 1 Appendix 3\nAn appendix to Consent form 1 has been created in light of the protocol change to examine the impact of COVID-19\non participants who are taking part in CARMS. It ensures that the CARMS team have obtained informed consent from\nparticipants for the collection and analysis of information related to the impact of COVID-19.\n4. Topic Guide 1 Appendix 1\nAn appendix to topic guide 1 has been created in light of the protocol change to examine the impact of COVID-19 on\nparticipants who are taking part in CARMS. The appendix will comprise of questions which explore i. the participant’s\nexperience of the COVID-19 outbreak, ii. how they are feeling about taking part in CARMS during the COVID-19. outbreak and iii. how they feel the COVID-19 outbreak has impacted on their mental health and suicidal thoughts and/or behaviour. It should be noted that with qualitative semi-structured interviews the actual questions asked will\nvary depending on the relationship between the interviewer and the participant, and also the analyses of prior interviews. Such analyses indicate new areas for investigation. Hence, the topic guide presented give an idea of the areas which will be covered during the interviews.\n5. Additional COVID-19 questions for CARMS appointments\nA document has been created to record answers to the three additional COVID-19 related questions to be asked\nduring clinical interviews and therapy sessions.\nThe questions will ascertain whether participants have symptoms of COVID-19, if they are self-isolating and the\nspecific reason they are self-isolating.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0089
Date of REC Opinion
21 Mar 2017
REC opinion
Favourable Opinion