A Randomized Trial for Suicidal Patients

NCT02685943 | Completed

• 1 other identifier: REK 2014/465
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Attempted Suicide; Suicide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in scores on The Outcome Questionaire 45 (OQ-45)

  From baseline to 6 and 12 months after patient is included in the study

• Norwegian Patient Registry (NPR) data

  Yearly for five years after study inclusion

• Changes in scores on Suicide Attempt Self-Injury Count (SASI-C)

  changes from baseline to 6 and 12 months after patient is included in the study

Study Arms (2)

CAMS treatment

EXPERIMENTAL

Psychotherapy using the Collaborative Assessment and Management of Suicidality framework

Behavioral: Psychotherapy

Treatment as usual

ACTIVE COMPARATOR

Ordinary treatment for suicidal patients

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

CAMS treatment; Treatment as usual

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Significant suicide ideation on Beck's Scale for Suicide Ideation (score 13 and above). Informed consent to participate.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• The Catholic University of America: collaborator
• Helse Sor-Ost: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Vestre Viken Helseforetak

Drammen, 3004, Norway

Location

Related Publications (3)

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 27716298 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Roar Fosse, Ph.D.

  Division of mental health and addiction, Vestre Viken

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 19, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)