A Randomized Trial for Suicidal Patients

NCT ID: NCT02685943

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2019-10-01

Brief Summary

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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

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Conditions

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Suicidal Ideation Attempted Suicide Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CAMS treatment

Psychotherapy using the Collaborative Assessment and Management of Suicidality framework

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

Treatment as usual

Ordinary treatment for suicidal patients

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type BEHAVIORAL

Interventions

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Psychotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of America

OTHER

Sponsor Role collaborator

Helse Sor-Ost

OTHER_GOV

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roar Fosse, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of mental health and addiction, Vestre Viken

Locations

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Vestre Viken Helseforetak

Drammen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32368793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27716298 (View on PubMed)

Other Identifiers

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REK 2014/465

Identifier Type: -

Identifier Source: org_study_id

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