Viewing Study NCT06606249



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06606249
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-11

Brief Title: Self-Help Plus for Distress in University Students
Sponsor: None
Organization: None

Study Overview

Official Title: Randomized Trial of a Brief Transdiagnostic Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SSH
Brief Summary: Prrospective multi-center randomized controlled trial of a brief transdiagnostic guided self-help intervention Self-Help Plus for university students who experience significant distress and are behind on their coursework The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress anxiety depression and well-being assessed immediately after the intervention and at 3-months follow-up
Detailed Description: The university period usually overlaps with a particularly challenging developmental period of transition to adulthood and a suite of significant and durable stressors such as independent living financial problems interpersonal relationships with family or peers and academic pressure Consequently it represents a critical high-risk period for the onset of mental disorders including anxiety depression substance abuse self-harm and suicidal behavior In the World Mental Health Surveys a set of large-scale cross-national community epidemiological surveys the 12-month prevalence of any mental disorder among university students was around 20 Further compounding the problem a large survey on first year university students in high-income countries showed that approximately 36 of students with any lifetime mental disorder or with suicidal thoughts or behaviors had received any treatment for emotional problems in the past year Lack of awareness of the problem and fear of stigma might account for the low treatment uptake in university students

Furthermore university psychological counseling services when available have limited impact due to their isolation from the general health care system and to the heterogeneity of the interventions offered An alternative innovative framework to promote access to mental health interventions while minimizing the risk of stigmatization is indirect prevention This approach includes interventions that address vulnerability factors increasing the risk of mental disorders while at the same time representing salient everyday problems that students are motivated to change In a diathesis-stress model mental disorders are triggered by the interaction between individual vulnerability factors and stressors such as academic challenges

A promising candidate intervention is Self-Help Plus SH developed by the World Health Organization WHO and intended to help individuals cope with distress stemming from a diversity of stressors In its individual online version called Doing What Matters in Times of Stress SH might be particularly suitable for university students given its easily implementable structure 5 sessions of guided self-help its contents focused on self-compassion coping with stress and personal values and delivery format not requiring specialized training Only two randomized trials so far employed SH as a preventive intervention targeting refugees in Western Europe and Turkey This is the first attempt to test SH as a preventive intervention on university students

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None