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NCT Number: NCT02685943

A Randomized Trial for Suicidal Patients

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.

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Key information

Conditions

Suicidal Ideation Attempted Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide, Attempted

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Helseforetak

Drammen, 3004, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychotherapy

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Helse Sor-Ost
  • Norwegian Institute of Public Health
  • The Catholic University of America

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2016
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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