A Randomized Trial for Suicidal Patients

Study Overview
=================
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.

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

Conditions
-----------------
Suicidal Ideation, Attempted Suicide, Suicide

Intervention / Treatment
-----------------
* Behavioral: Psychotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMS treatment<br>Psychotherapy using the Collaborative Assessment and Management of Suicidality framework | Behavioral: Psychotherapy<br> <br> |
| Active Comparator: Treatment as usual<br>Ordinary treatment for suicidal patients | Behavioral: Psychotherapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |