Online Self-help for Students With Suicidal Ideation
Primary Purpose
Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Unguided web-based intervention
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility Criteria
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: /
Sites / Locations
- Flemish Centre of Expertise in Suicide Prevention, Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Participants in this group (all participants) were asked to complete a questionnaire before and after (6 weeks after baseline) using the online self-help intervention (unguided web-based intervention).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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").
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").
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05636722
Brief Title
Online Self-help for Students With Suicidal Ideation
Official Title
Evaluation of an Unguided Web-based Intervention for Students With Suicidal Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in this group (all participants) were asked to complete a questionnaire before and after (6 weeks after baseline) using the online self-help intervention (unguided web-based intervention).
Intervention Type
Behavioral
Intervention Name(s)
Unguided web-based intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Suicidal ideation: Beck Scale for Suicide Ideation
Description
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.
Time Frame
Baseline (right before the intervention)
Title
Suicidal ideation: Beck Scale for Suicide Ideation
Description
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.
Time Frame
posttest (6 weeks after baseline)
Secondary Outcome Measure Information:
Title
Hopelessness: The Beck Hopelessness Scale, 4-item version
Description
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.
Time Frame
Baseline (right before the intervention)
Title
Hopelessness: The Beck Hopelessness Scale, 4-item version
Description
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.
Time Frame
posttest (6 weeks after baseline)
Title
Worrying: Penn State Worry Questionnaire Past Week
Description
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").
Time Frame
Baseline (right before the intervention)
Title
Worrying: Penn State Worry Questionnaire Past Week
Description
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").
Time Frame
posttest (6 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
/
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva De Jaegere, Msc
Phone
+32 (0)9 332.07.75
Email
eva.dejaegere@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Stas, Msc
Phone
+32 (0)9 332.07.75
Email
pauline.stas@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, Phd
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flemish Centre of Expertise in Suicide Prevention, Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva De Jaegere, MSc
Phone
+3293320775
Email
eva.dejaegere@ugent.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Online Self-help for Students With Suicidal Ideation
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