Suicidal IdeationNCT02685943
A Randomized Trial for Suicidal Patients
A study testing Psychotherapy in people with Suicidal Ideation and Attempted Suicide, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Suicidal Ideation, Attempted Suicide, Suicide
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2015to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Significant suicide ideation on Beck's Scale for Suicide Ideation (score 13 and above). Informed consent to participate.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
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
- Being tested
- Psychotherapy
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CAMS treatment | Experimental | Psychotherapy using the Collaborative Assessment and Management of Suicidality framework Receives: Behavioral: Psychotherapy |
| Treatment as usual | Active comparator | Ordinary treatment for suicidal patients Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
A 45-item questionnaire designed to measure key areas of mental health functioning (symptoms, interpersonal problems and social role functioning)
Measured: From baseline to 6 and 12 months after patient is included in the study
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.
Measured: Yearly for five years after study inclusion
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
Measured: changes from baseline to 6 and 12 months after patient is included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start1 Apr 2015
- Primary completion1 Apr 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of America, Helse Sor-Ost, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Roar Fosse, Ph.D., Principal investigator, Division of mental health and addiction, Vestre Viken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685943
- Sponsor's protocol ID
- REK 2014/465
- Status last verified
- Apr 2021
- First submitted
- 8 Feb 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual patient data will not be shared/ published
Publications
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.
PubMed 33884617Storebo 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.
PubMed 32368793Ryberg 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.
PubMed 27716298
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02685943
- Acronym / sponsor ID
- REK 2014/465
- Conditions
- Suicidal Ideation, Attempted Suicide, Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- The Catholic University of America, Helse Sor-Ost, Norwegian Institute of Public Health
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAMS treatment | Experimental | Behavioral: PsychotherapyPsychotherapy using the Collaborative Assessment and Management of Suicidality framework |
| Treatment as usual | Active comparator | Behavioral: PsychotherapyOrdinary treatment for suicidal patients |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Significant suicide ideation on Beck's Scale for Suicide Ideation (score 13 and above). Informed consent to participate.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy | Behavioural | CAMS treatment, Treatment as usual |
Primary outcome
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.
3 secondary outcomes
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
Norwegian Patient Registry (NPR) data
Time frame: Yearly for five years after study inclusion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 27716298Ryberg 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.
- Individual participant dataSharing planned: No. Individual patient data will not be shared/ published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roar Fosse, Ph.D. principal investigator
Division of mental health and addiction, Vestre Viken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Suicidal Ideation and Attempted Suicide, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02685943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021; AzTrials last refreshed its copy on 27 Oct 2026.