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A Randomized Trial for Suicidal Patients

Primary Purpose

Suicidal Ideation, Attempted Suicide, Suicide

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Vestre Viken Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vestre Viken Helseforetak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAMS treatment

Treatment as usual

Arm Description

Psychotherapy using the Collaborative Assessment and Management of Suicidality framework

Ordinary treatment for suicidal patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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

Full Information

First Posted
February 8, 2016
Last Updated
April 13, 2021
Sponsor
Vestre Viken Hospital Trust
Collaborators
The Catholic University of America, Helse Sor-Ost, Norwegian Institute of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02685943
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust
Collaborators
The Catholic University of America, Helse Sor-Ost, Norwegian Institute of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Attempted Suicide, Suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAMS treatment
Arm Type
Experimental
Arm Description
Psychotherapy using the Collaborative Assessment and Management of Suicidality framework
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Ordinary treatment for suicidal patients
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Primary Outcome Measure Information:
Title
Changes in scores on Beck's Scale for Suicide Ideation (BSSI)
Description
Interview scale with 19 items that measures a patient's suicidal ideation at its worst point in the past 2 weeks.
Time Frame
From baseline to 6 and 12 months after patient is included in the study
Secondary Outcome Measure Information:
Title
Changes in scores on The Outcome Questionaire 45 (OQ-45)
Description
A 45-item questionnaire designed to measure key areas of mental health functioning (symptoms, interpersonal problems and social role functioning)
Time Frame
From baseline to 6 and 12 months after patient is included in the study
Title
Norwegian Patient Registry (NPR) data
Description
Data entered in the NPR on self harm, suicide attempts, new hospital admissions to health treatments, discharge diagnosis, intoxication, and death by any causes.
Time Frame
Yearly for five years after study inclusion
Title
Changes in scores on Suicide Attempt Self-Injury Count (SASI-C)
Description
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
Time Frame
changes from baseline to 6 and 12 months after patient is included in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roar Fosse, Ph.D.
Organizational Affiliation
Division of mental health and addiction, Vestre Viken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestre Viken Helseforetak
City
Drammen
ZIP/Postal Code
3004
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be shared/ published
Citations:
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
32368793
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.
Results Reference
derived
PubMed Identifier
27716298
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.
Results Reference
derived

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A Randomized Trial for Suicidal Patients

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