Self-Help Plus for Distress in University Students
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Padova
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
University students across all years of higher education (i.e., bachelor and masters), enrolled in any degree course, starting from the second semester of the 1st year
Currently behind coursework by at least 3 exams, including: exams failed, for which the obtained grade was not confirmed by the student (i.e., confirming the grade is mandatory in the Italian academic system), or postponed (i.e., not taken in the regularly scheduled period).
Experience significant distress as assessed by the Kessler psychological distress scale (K-10) ≥ 16.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Help Plus (SH+)
BehavioralSelf-Help Plus is a novel, brief, low-intensity intervention, recently developed by the World Health Organization (WHO) and intended to help people with and without mental disorders cope with distress stemming from diverse types of adversity.The key components of the program are based on acceptance and commitment therapy (ACT), a distinct form of cognitive-behavioural therapy. SH+ draws on ACT techniques of coping with stress, compassion and acceptance toward oneself and others, and living following one's values. An online version called "Doing what matters in times of stress" is available as an illustrated guide and pre-recorded audio.
Psychological First Aid (PFA)
BehavioralPsychological First Aid (PFA) is also developed by the WHO and is a general supportive intervention, aimed at listening and understanding the needs and concerns of people, providing support without pressuring them to talk.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Self-Help Plus (SH+)Experimental treatment 1 intervention
Group B: Psychological First Aid (PFA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Kessler psychological distress scale
The Kessler psychological distress scale (K-10) is a simple measure of psychological distress. It consists of 10 questions about emotional states that can be answered from 1 (none of the time) to 5 (all of the time). Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50.
Time frame
Baseline, After the intervention, At 3 months after the interventionSecondary outcomes
1
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) is a self-report instrument to measure depression. It consists of 9 items, each rated on a 4-point scale ranging from 0 (not at all) to 3 (almost every day). Total scores range from 0 to 27.
Time frame
Baseline, After the intervention, At 3 months after the intervention2
The Generalized Anxiety Disorder-7
The General Anxiety Disorder-7 (GAD-7) scale is a measure of symptoms of generalized anxiety. It consists of 7 items that can be rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 21.
Time frame
Baseline, After the intervention, At 3 months after the intervention3
World Health Organization Well-Being Index
World Health Organization Well-Being Index (WHO-5) assesses subjective well-being. It consists of 5 items, each rated on a 6-point scale ranging from 0 (at no time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, ranging from 0 to 100.
Time frame
Baseline, After the intervention, At 3 months after the intervention4
Numbers of exams sustained
Self-reported number of exams sustained over the study period
Time frame
Baseline, After the intervention, At 3 months after the interventionOther outcomes
1
Accesibility
Easy access to the online intervention and to the rating scales
Time frame
Immediately after the intervention2
Intervention dose
Number of sessions attended by each participant, and the time spent in each session measured in minutes
Time frame
Immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Padova
Lead sponsor
Universita di Verona
Collaborator
University of Bari Aldo Moro
Collaborator
Source ClinicalTrials.gov