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Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial.

ABSTRACT: Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that appears promising to reduce suicidal ideation and suicidal cognition. CAMS has not previously been evaluated in a standard specialized mental health care setting for patients with suicidal problems in general. In this pragmatic randomized controlled trial (RCT) we will investigate if CAMS is more effective than treatment as usual (TAU) in reducing suicidal thoughts and behaviors. Effects will also be investigated on mental health and symptom relief in general and upon readmissions to inpatient units.The study is a multicenter, observer-blinded, superiority, two-armed RCT which will include patients from four clinical departments at Vestre Viken Hospital Trust, Norway. We aim to include 100 patients with moderate to strong suicidal problems, as defined by a score of 13 or more on Beck's Scale for Suicide Ideation - Current. Patients are included regardless of diagnosis. Randomization will be performed using a stratified four-block procedure with treatment unit as the stratification variable. The duration of treatment will vary depending on patients' needs and clinical assessments. Patients are interviewed by research staff at four checkpoints: baseline, 2 weeks, 6 months, and 12 months. Central outcome measures are the Beck Scale for Suicide Ideation - Current, Outcome Questionnaire - 45, and Suicide Attempt Self-Injury Count.This pragmatic trial is effectuated within the Public Health Care System in Norway, where patients have multiple problems and diagnoses and therapists have a high work load. Results from this trial are highly generalizable to a typical everyday clinical setting, and one should expect similar results if CAMS is implemented in the future as a standard component in specialized mental health care systems.Open Science Framework: DOI 10.17605/OSF.IO/JHRM2 . Registered 5 July 2015. ClinicalTrials.gov: NCT02685943 . Registered on 8 February 2016.

SUBMITTER: Ryberg W

PROVIDER: S-EPMC5048411 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial.

Ryberg Wenche W Fosse Roar R Zahl Per Henrik PH Brorson Inge I Møller Paul P Landrø Nils Inge NI Jobes David D

Trials 20161003 1

<h4>Background</h4>Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that appears promising to reduce suicidal ideation and suicidal cognition. CAMS has not previously been evaluated in a standard specialized mental health care setting for patients with suicidal problems in general. In this pragmatic randomized controlled trial (RCT) we will investigate if CAMS is more effective than treatment as usual (TAU) in reducing suicidal thoughts and behaviors. Effe ...[more]

PMID: 27716298

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Project description:BackgroundThe Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that has been shown to reduce suicidal ideation and overall symptom distress. CAMS has not been previously evaluated in a standard acute inpatient mental health care setting with only short treatment times for suicidal patients. In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable. We are also investigating depressive symptoms, general symptom relief, and the quality of the therapeutic alliance as secondary outcomes.Methods/designThis RCT is designed as a single-center, two-armed, parallel group observer-blinded clinical effectiveness investigation. We are recruiting and randomizing 60 participants with different diagnoses, who are admitted as inpatients because of acute suicidal thoughts or behaviors into the Clinic for Psychiatry and Psychotherapy, Ev. Hospital Bethel in Bielefeld, Germany. The duration of treatment will vary depending on patients' needs and clinical assessments ranging between 10 and 40 days. Patients are assessed four times, at admission, discharge, 1 month, and 5 months post-discharge. The primary outcome measure is the Beck Scale for Suicide Ideation. Other outcome measures are administered as assessment timepoints including severity of psychiatric symptoms, depression, reasons for living, and therapeutic relationship.DiscussionThis effectiveness study is being conducted on an acute ward in a psychiatric clinic where patients have multiple problems and diagnoses. Treatment is somewhat limited, and therapists have a large caseloads. The results of this study can thus be generalizable to a typical inpatient psychiatric hospital settings.Trial registrationThis clinical trial has been retrospectively registered with the German Clinical Trials Register; registration code/ DRKS-ID: DRKS00013727 (on January 12, 2018). In addition, the study was also registered with the International Clinical Trials Registry Platform of the World Health Organization (identical registration code). Registry Name: "Evaluation von CAMS versus TAU bei suizidalen Patienten - Ein stationärer RCT".

Project description:BackgroundAlthough use of inpatient crisis hospital intervention for suicide risk is common, the evidence for inpatient treatments that reduce suicidal thoughts and behaviors is remarkably limited. To address this need, this novel feasibility pilot randomized controlled trial compared the use of the Collaborative Assessment and Management of Suicidality (CAMS) to enhanced treatment as usual (E-TAU) within a standard acute inpatient mental health care setting.ObjectivesWe hypothesized that CAMS would be more effective than E-TAU in reducing suicidal thoughts and behaviors. As secondary outcomes we also investigated depressive symptoms, general symptom burden, reasons for living, and quality of the therapeutic relationship.MethodsAll patients were admitted due to acute suicidal thoughts or behaviors. They were randomly assigned to CAMS (n = 43) or E-TAU (n = 45) and assessed at four time points (admission, discharge, 1 month and 5 months after discharge). We used mixed-effects models, effect sizes, and reliable change analyses to compare improvements across and between treatment groups over time.ResultsIntent-to-treat analyses of 88 participants [mean age 32.1, SD = 13.5; n = 47 (53%) females] showed that both groups improved over time across all outcome measures with no significant between-group differences in terms of change in suicidal ideation, depression, reasons for living, and distress. However, CAMS showed larger effect sizes across all measures; for treatment completers CAMS patients showed significant improvement in suicidal ideation (p = 0.01) in comparison to control patients. CAMS patients rated the therapeutic relationship significantly better (p = 0.02) than E-TAU patients and were less likely to attempt suicide within 4 weeks after discharge (p = 0.05).ConclusionsCAMS and E-TAU were both effective in reducing suicidal thoughts and symptom distress. Within this feasibility RCT the pattern of results was generally supportive of CAMS suggesting that inpatient use of CAMS is both feasible and promising. However, our preliminary results need further replication within well-powered multi-site randomized controlled trials.Trial registrationDRKS-ID/ICTRP-ID: DRKS00013727. The trial was retrospectively registered in the German Clinical Trials Register, registration code/ DRKS-ID: DRKS00013727 on 12.01.2018 and also in the International Clinical Trials Registry Platform of the World Health Organization (identical registration code).

Project description:BACKGROUND:Suicide is a global public health concern, but it is preventable. Increased contact with primary care before the suicide or attempted suicide raises opportunities for intervention and prevention. However, suicide assessment and management are areas that many general practitioners (GPs) find particularly challenging. Previous research has indicated significant variability in how GPs understand, operationalize, and assess suicide risk, which subsequently has an impact on clinical decision making. Clinical decision support systems (CDSS) have been widely implemented across different health care settings, including primary care to support practitioners in clinical decision making. A CDSS may reduce inconsistencies in the identification, assessment, and management of suicide risk by GPs by guiding them through the consultation and generating a risk assessment plan that can be shared with a service user or with specialized mental health services. OBJECTIVE:Our aim is to co-develop and test with end users (eg, GPs, primary care attendees, mental health professionals) an electronic clinical decision support system (e-CDSS) to support GPs in the identification, assessment, and management of suicidality in primary care. METHODS:Ours is an ongoing embedded mixed-methods study with four phases: (1) qualitative interviews with GPs to explore their views on the content, format, and use of the e-CDSS, as well as consultation with two service-user advisory groups (people aged ≤25 and people aged ≥25) to inform the content of the e-CDSS including phrasing of items and clarity; (2) participatory co-production workshops with GPs, service users, and clinical experts in suicidality to determine the content and format of the e-CDDS; gain consensus of the relevance of items; establish content validity and identify pathways to implementation, using the Consolidated Framework for Implementation Research; (3) building the e-CDSS so that it guides the GP through a consultation; and (4) usability testing of the e-CDSS with GPs and service users in one primary care practice involving a nonlive and a live stage. RESULTS:The study was funded for four years, to take place between 2015 and 2019, and is currently completing phase 4 data collection. The first results are expected to be submitted for publication in June 2019. The findings will enable us to evaluate the feasibility, acceptability, and usability of a suicide-specific, electronic, guided decision support system in primary care. CONCLUSIONS:This study will be the first to explore the feasibility, acceptability, and usability of an electronic, guided decision support system for use in primary care consultations for the improved assessment and management of suicidality. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/11135.

Project description:BackgroundIn Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual.Methods/designThe trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments.Trial registrationClinical Trial.gov: NCT01512602.

Dataset Information

Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial.

Publications

Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial.

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