Self-Help Plus for Distress in University Students (SSH+)

Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Psychological Distress; Psychological Well-Being
• Intervention / Treatment: Behavioral: Self-Help Plus (SH+); Behavioral: Psychological First Aid (PFA)

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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ioana Cristea, PhD; Phone Number: 390498276595; Email: ioanaalina.cristea@unipd.it

Study Locations

• Italy
  • Padua, Italy, 35131
    • Recruiting
    • University of Padova
    • Contact: Marcella Lucente, PhD; Phone Number: +390498276595; Email: marcella.lucente@unipd.it
    • Principal Investigator: Ioana Cristea, PhD
  • Verona, Italy
    • Recruiting
    • Universita di Verona
    • Contact: Federica Patania, MSc; Phone Number: +039045 8124884; Email: federica.patania@univr.it
    • Principal Investigator: Marianna Purgato, PhD
  • Bari
    • Bari, Bari, Italy, 70121
      • Not yet recruiting
      • University of Bari "Aldo Moro"
      • Contact: Emilia Matera, Ph.D.; Phone Number: 0805595258; Email: emilia.matera@uniba.it
      • Sub-Investigator: Lucia Margari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Help Plus (SH+); The intervention is available in its individual online self-help version called "Doing What Matters in Time of Stress". It composed of an illustrate guide, divided into sessions, and pre-recorded audio. Participants will be required to access an online platform for attending the sessions. A total of 5 sessions of approximately an hour each are planned. Participants will be guided by facilitators with minimal qualifications and skills in providing psychosocial support. They will receive regular reminders and instructions from helpers at the beginning of the program and before any sessions via phone call, teleconferencing meeting, or message. Facilitators will receive brief training from specialized mental health professionals trained by WHO.	Behavioral: Self-Help Plus (SH+); Self-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.; Other Names: Doing what matters in times of stress
Active Comparator: Psychological First Aid (PFA); Psychological First Aid will also be delivered by facilitators through a phone call or teleconferencing meeting, for an approximate ranging from 20 to 45 minutes. Participants will also receive an information sheet with details about mental health services available for students experiencing distress at each of the centers.	Behavioral: Psychological First Aid (PFA); Psychological 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, After the intervention, At 3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, After the intervention, At 3 months after the intervention
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.	Baseline, After the intervention, At 3 months after the intervention
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.	Baseline, After the intervention, At 3 months after the intervention
Numbers of exams sustained	Self-reported number of exams sustained over the study period	Baseline, After the intervention, At 3 months after the intervention
Academic deceit survey	An ad hoc tool with three questions will be used: (a) did you lie to significant others about academic status; (b) how frequently, on a scale ranging from 0 (never) to 4 (always) and (c) in which situations (open ended)	Baseline, After the intervention, At 3 months after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accesibility	Easy access to the online intervention and to the rating scales	Immediately after the intervention
Intervention dose	Number of sessions attended by each participant, and the time spent in each session measured in minutes	Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Universita di Verona; University of Bari Aldo Moro
• Investigators: Principal Investigator: Ioana Cristea, PhD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prevention; university students; emotion regulation; academic deceit
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Social Behavior; Self-Control; Anxiety Disorders; Depression; Psychological Well-Being; Emotional Regulation; Behavioral Disciplines and Activities; Mental Health Services; Emergency Services, Psychiatric; Psychological First Aid
• Other Study ID Numbers: 20224XSWRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Fully anonymized and de-identified individual participant data will be made available, following a request and the signing of a data sharing agreement, completed by the data requestor and directed to the principal investigator. Complete metadata and analysis scripts will be made publicly available with each publication.

Individual participant data will be made available for research purposes only, including replication. The data will not be made available for non-research purposes in accordance with the legal framework underpinning ethical approval and informed consent.

• IPD Sharing Time Frame: One year after study completion.
• IPD Sharing Access Criteria: Interested parties will have to submit a data request including as a minimum the purpose of accessing the data, how the data will be used and how findings will be disseminated. A data sharing agreement will be signed between the requestor and principal investigator underlying the purposes and conditions for which data will be used.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No