Suicidal IdeationNCT05636722
Online Self-help for Students With Suicidal Ideation
A study testing Unguided web-based intervention in people with Suicidal Ideation, run by University Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Unguided web-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2022to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be student at a university or college
- Have suicidal thoughts
- ≥ 18 years old
- Have access to internet and a computer/laptop/smartphone
- Speak Dutch
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Flemish Centre of Expertise in Suicide Prevention, Ghent University
Ghent, 9000
About this study
Official title: 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.
- Conditions
- Suicidal Ideation
- Being tested
- Unguided web-based intervention
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unguided web-based interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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). Receives: Behavioral: Unguided web-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (right before the intervention)
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.
Measured: posttest (6 weeks after baseline)
Secondary outcomes (4)
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.
Measured: Baseline (right before the intervention)
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.
Measured: posttest (6 weeks after baseline)
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").
Measured: Baseline (right before the intervention)
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").
Measured: posttest (6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: 1. Technical reasons with the online platform for students. 2. Limited number of students using the modules of self-help for suicide: recruitment was not started and the study was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636722
- Sponsor's protocol ID
- EC/BC-11287
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Unguided Web-based Intervention for Students With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT05636722
- Acronym / sponsor ID
- EC/BC-11287
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 1. Technical reasons with the online platform for students. 2. Limited number of students using the modules of self-help for suicide: recruitment was not started and the study was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Unguided web-based interventionParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be student at a university or college
- Have suicidal thoughts
- ≥ 18 years old
- Have access to internet and a computer/laptop/smartphone
- Speak Dutch
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Unguided web-based interventionAn 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). | Behavioural | Intervention group |
Primary outcome
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.
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.
4 secondary outcomes
Hopelessness: The Beck Hopelessness Scale, 4-item version
Time frame: Baseline (right before the intervention)
Hopelessness: The Beck Hopelessness Scale, 4-item version
Time frame: posttest (6 weeks after baseline)
Worrying: Penn State Worry Questionnaire Past Week
Time frame: Baseline (right before the intervention)
Worrying: Penn State Worry Questionnaire Past Week
Time frame: posttest (6 weeks after baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
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.
Gwendolyn Portzky, Phd principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unguided web-based intervention in people with Suicidal Ideation, run by University Ghent at 1 site in Belgium.
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 5 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Suicidal ideation: Beck Scale for Suicide Ideation (time frame: Baseline (right before the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.