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A Randomized Trial for Suicidal Patients

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ClinicalTrials.gov Identifier: NCT02685943
Recruitment Status : Unknown
Verified October 2016 by Vestre Viken Hospital Trust.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : December 6, 2016
Sponsor:
Collaborators:
The Catholic University of America
Helse Sor-Ost
Norwegian Institute of Public Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Attempted Suicide Suicide Behavioral: Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: CAMS treatment
Psychotherapy using the Collaborative Assessment and Management of Suicidality framework
Behavioral: Psychotherapy
Active Comparator: Treatment as usual
Ordinary treatment for suicidal patients
Behavioral: Psychotherapy



Primary Outcome Measures :
  1. Changes in scores on Beck's Scale for Suicide Ideation (BSSI) [ Time Frame: 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 :
  1. Changes in scores on The Outcome Questionaire 45 (OQ-45) [ Time Frame: 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)

  2. Norwegian Patient Registry (NPR) data [ Time Frame: 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.

  3. Changes in scores on Suicide Attempt Self-Injury Count (SASI-C) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685943


Locations
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Norway
Vestre Viken Helseforetak
Drammen, Norway, 3004
Sponsors and Collaborators
Vestre Viken Hospital Trust
The Catholic University of America
Helse Sor-Ost
Norwegian Institute of Public Health
Investigators
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Principal Investigator: Roar Fosse, Ph.D. Division of mental health and addiction, Vestre Viken

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT02685943     History of Changes
Other Study ID Numbers: REK 2014/465
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared/ published
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms