Clinical trial NCT02685943: A Randomized Trial for Suicidal Patients
Official title: "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Attempted Suicide
Suicide
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: The Catholic University of America
name: Helse Sor-Ost
name: Norwegian Institute of Public Health
First posted: 2016-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although suicide risk is highly prevalent among the patient population in mental health care, remarkably little research exists on effective treatments. Among a small set of novel approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide attempts, with secondary outcome measures including general symptoms of mental health problems. Changes in the outcome measures are compared between the two groups from baseline to 6 and 12 months after patients are included in the study. The study has the potential to impact the science of treating suicidal individuals and it could benefit the general public by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.


Eligibility criteria: Inclusion Criteria:

* Significant suicide ideation on Beck's Scale for Suicide Ideation (score 13 and above). Informed consent to participate.

Exclusion Criteria:

* Active psychosis, cognitive or physical impairment or other problems that preclude the ability to understand the study procedures and provide informed consent, non-Norwegian speaking subjects

Primary outcomes:
measure: Changes in scores on Beck's Scale for Suicide Ideation (BSSI)
timeFrame: From baseline to 6 and 12 months after patient is included in the study
Secondary outcomes:
measure: Changes in scores on The Outcome Questionaire 45 (OQ-45)
timeFrame: From baseline to 6 and 12 months after patient is included in the study
measure: Norwegian Patient Registry (NPR) data
timeFrame: Yearly for five years after study inclusion
measure: Changes in scores on Suicide Attempt Self-Injury Count (SASI-C)
timeFrame: changes from baseline to 6 and 12 months after patient is included in the study
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Helseforetak
Study officials:
affiliation: Division of mental health and addiction, Vestre Viken
name: Roar Fosse, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Ryberg W, Fosse R, Zahl PH, Brorson I, Moller P, Landro NI, Jobes D. Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial. Trials. 2016 Oct 3;17(1):481. doi: 10.1186/s13063-016-1602-z.