A Randomized Trial for Suicidal Patients

Suicide Clinical Trial

Official title:

"Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685943
• Other study ID #: REK 2014/465
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: October 1, 2019

Study information

• Verified date: April 2021
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Attempted Suicide
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Psychotherapy

Locations

Country	Name	City	State
Norway	Vestre Viken Helseforetak	Drammen

Sponsors (4)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Helse Sor-Ost, Norwegian Institute of Public Health, The Catholic University of America

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in scores on Beck's Scale for Suicide Ideation (BSSI)	Interview scale with 19 items that measures a patient's suicidal ideation at its worst point in the past 2 weeks.	From baseline to 6 and 12 months after patient is included in the study
Secondary	Changes in scores on The Outcome Questionaire 45 (OQ-45)	A 45-item questionnaire designed to measure key areas of mental health functioning (symptoms, interpersonal problems and social role functioning)	From baseline to 6 and 12 months after patient is included in the study
Secondary	Norwegian Patient Registry (NPR) data	Data entered in the NPR on self harm, suicide attempts, new hospital admissions to health treatments, discharge diagnosis, intoxication, and death by any causes.	Yearly for five years after study inclusion
Secondary	Changes in scores on Suicide Attempt Self-Injury Count (SASI-C)	An interview covering past self-inflicted injuries and categorizing them into suicide attempts and non-suicidal acts. The tool also creates counts of self-inflicted injuries by method, medical risk severity and lethality	changes from baseline to 6 and 12 months after patient is included in the study