A Randomized Trial for Suicidal Patients

Not Applicable

Completed

• Conditions: Suicidal Ideation; Attempted Suicide; Suicide
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT02685943
• Lead Sponsor: Vestre Viken Hospital Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-19
• Primary Completion: 2019-04-01
• Study Completion: 2019-10-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Psychotherapy	Ordinary treatment for suicidal patients
CAMS treatment	Psychotherapy	Psychotherapy using the Collaborative Assessment and Management of Suicidality framework

Primary Outcome Measures

Name	Time	Method
Changes in scores on Beck's Scale for Suicide Ideation (BSSI)	From baseline to 6 and 12 months after patient is included in the study	Interview scale with 19 items that measures a patient's suicidal ideation at its worst point in the past 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Norwegian Patient Registry (NPR) data	Yearly for five years after study inclusion	Data entered in the NPR on self harm, suicide attempts, new hospital admissions to health treatments, discharge diagnosis, intoxication, and death by any causes.
Changes in scores on The Outcome Questionaire 45 (OQ-45)	From baseline to 6 and 12 months after patient is included in the study	A 45-item questionnaire designed to measure key areas of mental health functioning (symptoms, interpersonal problems and social role functioning)
Changes in scores on Suicide Attempt Self-Injury Count (SASI-C)	changes from baseline to 6 and 12 months after patient is included in the study	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

Trial Locations

Locations (1)

Vestre Viken Helseforetak; 🇳🇴 Drammen, Norway