- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636722
Online Self-help for Students With Suicidal Ideation
December 4, 2023 updated by: University Ghent
Evaluation of an Unguided Web-based Intervention for Students With Suicidal Ideation
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eva De Jaegere, Msc
- Phone Number: +32 (0)9 332.07.75
- Email: eva.dejaegere@ugent.be
Study Contact Backup
- Name: Pauline Stas, Msc
- Phone Number: +32 (0)9 332.07.75
- Email: pauline.stas@ugent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Flemish Centre of Expertise in Suicide Prevention, Ghent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicidal ideation: Beck Scale for Suicide Ideation
Time Frame: Baseline (right before the intervention)
|
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)
|
Suicidal ideation: Beck Scale for Suicide Ideation
Time Frame: posttest (6 weeks after baseline)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hopelessness: The Beck Hopelessness Scale, 4-item version
Time Frame: Baseline (right before the intervention)
|
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)
|
Hopelessness: The Beck Hopelessness Scale, 4-item version
Time Frame: posttest (6 weeks after baseline)
|
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)
|
Worrying: Penn State Worry Questionnaire Past Week
Time Frame: Baseline (right before the intervention)
|
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)
|
Worrying: Penn State Worry Questionnaire Past Week
Time Frame: posttest (6 weeks after baseline)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gwendolyn Portzky, PhD, University Ghent
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
November 8, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Actual)
December 5, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/BC-11287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Technische Universität DresdenUnknownDepression | Suicidal Ideation/BehaviorGermany
-
International Islamic University, IslamabadRecruitingImpulsivity | Suicidal Ideation and BehaviorPakistan
-
VA Office of Research and DevelopmentCentral Texas Veterans Health Care SystemRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Eisenhower Army Medical CenterAugusta University; The Geneva Foundation; Congressionally Directed Medical Research...CompletedSuicidal Ideation | Suicide | Suicidal Intention | Suicidal Impulses | Suicidal and Self-Injurious Behavior | Suicidal DepressionUnited States
-
Rhode Island HospitalNational Institute of Mental Health (NIMH)Enrolling by invitation
Clinical Trials on Unguided web-based intervention
-
Anadolu UniversityEskisehir Osmangazi UniversityNot yet recruiting
-
Cardenal Herrera UniversityCompleted
-
Northwestern UniversityWithdrawnIndividuals at Risk for DepressionUnited States
-
Taipei Medical UniversityRecruitingInfertility | Heart Rate Variability | BiofeedbackTaiwan
-
NYU Langone HealthStanford University; Shaare Zedek Medical CenterCompletedAnxiety Disorders | Major Depression | Post Traumatic Stress DisorderIsrael
-
Taipei Medical UniversityNot yet recruitingParenting | Psychological Distress | Self Efficacy
-
Heidelberg UniversityCompetence Network for Congenital Heart DefectsRecruitingCongenital Heart Disease | Emotional RegulationGermany
-
Milton S. Hershey Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertensionUnited States
-
Hong Kong Baptist UniversityCompletedPhysically Well But WorriedHong Kong
-
Georgetown UniversityAlbert Einstein College of Medicine; University of MichiganCompletedTobacco Cessation | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Virus, Human Immunodeficiency | Tobacco-Use DisorderUnited States