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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05636722
Other study ID # EC/BC-11287
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2023

Study information

Verified date December 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main goal of this study is to evaluate the effectiveness of an unguided web-based intervention for (college/university) students with suicidal ideation. This study will test the effectiveness by studying the effect on suicidal ideation and related outcomes (hopelessness and worrying) through a pre-post study design.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be student at a university or college - Have suicidal thoughts - = 18 years old - Have access to internet and a computer/laptop/smartphone - Speak Dutch Exclusion Criteria: - /

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Unguided web-based intervention
An online unguided intervention based on Cognitive Behavioural Therapy and elements of Dialectical Behaviour Therapy, Problem Solving Therapy, and Mindfulness Based Cognitive Therapy. The intervention consists of 6 modules with each a theoretical part, a weekly assignment and (optional and mandatory) exercises. Participants are advised to complete one module weekly. The original intervention was adapted to students (language, addition of podcasts, examples that were more suited to their lives).

Locations

Country Name City State
Belgium Flemish Centre of Expertise in Suicide Prevention, Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Suicidal ideation: Beck Scale for Suicide Ideation A 21-item self-report questionnaire to measure (the severity of) suicidal ideation in adolescents and adults. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38, with higher scores indicating more (severe) suicidal ideation. Baseline (right before the intervention)
Primary Suicidal ideation: Beck Scale for Suicide Ideation A 21-item self-report questionnaire to measure (the severity of) suicidal ideation in adolescents and adults. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38, with higher scores indicating more (severe) suicidal ideation. posttest (6 weeks after baseline)
Secondary Hopelessness: The Beck Hopelessness Scale, 4-item version A 4-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness. Baseline (right before the intervention)
Secondary Hopelessness: The Beck Hopelessness Scale, 4-item version A 4-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness. posttest (6 weeks after baseline)
Secondary Worrying: Penn State Worry Questionnaire Past Week A 15-item self-report questionnaire to measure worrying in the past week. Each item is rated on a 7-point Likert scale ranging from 0 ("never") to 6 ("almost always"). Baseline (right before the intervention)
Secondary Worrying: Penn State Worry Questionnaire Past Week A 15-item self-report questionnaire to measure worrying in the past week. Each item is rated on a 7-point Likert scale ranging from 0 ("never") to 6 ("almost always"). posttest (6 weeks after baseline)
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