Online Self-help for Students With Suicidal Ideation

NCT05636722 | Withdrawn

• 1 other identifier: EC/BC-11287
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Hopelessness: The Beck Hopelessness Scale, 4-item version

  Baseline (right before the intervention)

• Hopelessness: The Beck Hopelessness Scale, 4-item version

  posttest (6 weeks after baseline)

• Worrying: Penn State Worry Questionnaire Past Week

  Baseline (right before the intervention)

• Worrying: Penn State Worry Questionnaire Past Week

  posttest (6 weeks after baseline)

Study Arms (1)

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).

Behavioral: Unguided web-based intervention

Interventions

Unguided web-based intervention BEHAVIORAL

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be student at a university or college
• Have suicidal thoughts
• ≥ 18 years old
• Have access to internet and a computer/laptop/smartphone
• Speak Dutch

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Flemish Centre of Expertise in Suicide Prevention, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Gwendolyn Portzky, Phd

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 5, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)