Online Self-help for Students With Suicidal Ideation

Sponsor

University Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05636722

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation	Behavioral: Unguided web-based intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of an Unguided Web-based Intervention for Students With Suicidal Ideation

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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).	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).

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).

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).

Outcome Measures

Primary Outcome Measures

Suicidal ideation: Beck Scale for Suicide Ideation [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 [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.

Secondary Outcome Measures

Hopelessness: The Beck Hopelessness Scale, 4-item version [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.
Hopelessness: The Beck Hopelessness Scale, 4-item version [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.
Worrying: Penn State Worry Questionnaire Past Week [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").
Worrying: Penn State Worry Questionnaire Past Week [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").

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Flemish Centre of Expertise in Suicide Prevention, Ghent University	Ghent		Belgium	9000

Sponsors and Collaborators

University Ghent

Investigators

Principal Investigator: Gwendolyn Portzky, Phd, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Ghent

ClinicalTrials.gov Identifier:

NCT05636722

Other Study ID Numbers:

EC/BC-11287

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Suicidal Ideation

Study Results

No Results Posted as of Dec 5, 2022