Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06370104

Treating Suicidality Remotely

Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.

Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.

Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Suicide Attempt Behavior Behavioral Symptoms Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Sensation Disorders Signs and Symptoms Suicide Suicide, Attempted Vision Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 16 years or older
  • Currently living in The Netherlands
  • Any type of STBs in the past 4 weeks

Exclusion criteria

  • Insufficient mastery of the Dutch language
  • Previously engaged in 113 Suicide Prevention's Online Therapy or Self-help course
  • Currently seeing a mental health professional at least once every 3 weeks, other then a general practitioner or general practice based nurse practitioner ('POH-GGZ')
  • Not able to engage in online therapy, for instance because of severe mood disorders or psychotic symptoms, based on the clinical impression of the research assistant and a supervisor

Treatment and study plan

Brief Cognitive Behavioral Therapy for Suicide Prevention

Behavioral

see arm description

Living under control

Behavioral

see arm description

Other names: Living with deadly thoughts

Primary outcomes

  1. Number of suicide attempts

    Time frame: 18-months follow-up

    Number of fatal and non-fatal suicide attempts, identified through the Columbia Suicide Severity Rating Scale (C-SSRS; non-fatal attempts), a contact provided by the participant or Statistics Netherlands (fatal attempts).

Secondary outcomes

  1. Severity of suicidal ideation

    Time frame: 18-months follow-up

    Severity of suicidal ideation as measured with the suicidal ideation subscale of the Suicide Severity Rating Scale. This sub scale results in a score from 1-5 based on the most severe type of suicidal ideation endorsed by the subject. For this study, subjects who do not report any suicidal ideation are assigned a score of 0.

  2. Severity of suicidal Thoughts and Behaviors Composite

    Time frame: 18-months follow-up

    A total score for STB severity will be derived from the Columbia Suicide Severity Rating Scale: subjects who report no suicidal thoughts or behaviors will be assigned a score of 0; subjects who report suicidal thoughts but not behaviors a score of 1-5, depending on their rating on the suicidal ideation subscale described above; subjects who report preparatory behavior but no attempt a score of 6; subjects who report an aborted attempt a score of 7; subjects who report an interrupted attempt a score of 8; and subjects who report a non-lethal attempt a score of 9. Subjects who have made a lethal attempt will be assigned a score of 10.

  3. Treatment satisfaction

    Time frame: post-treatment (approximately 12 weeks after the start of treatment)

    Treatment satisfaction as measured with the Client Satisfaction Questionnaire 8 (CSQ-8). The subject's scores on the 8 items of the scale are summed up, resulting in a score between 8 and 32, with higher values indicating higher satisfaction.

  4. Adverse effects

    Time frame: post-treatment (approximately 12 weeks after the start of treatment)

    Adverse effects as measured with the 20-item version of the Negative Effects Questionnaire (NEQ). The mean number of negative effects that clients report and attribute to the treatment is calculated.

  5. Co-occuring mental health issues

    Time frame: 18-months follow-up

    Co-occuring mental health issues as measured with the MINI neuropsychiatric interview - simplified. Two scores are calculated:

    • the mean number of symptoms per client
    • the mean number of classifications per client

  6. Quality of life

    Time frame: 18-months follow-up

    Quality of life as measured with the Mental Health Quality of Life Questionnaire. An overall index score is calculated by summing the scores of the seven questions. This index score can vary from 0 to 21, with higher scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

113 Suicide Prevention

Other

Collaborators

  • Amsterdam UMC

Registry information

Official study title

Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone

Acronym: TREASURE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2024
Registry last updated
May 20, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.