Psychological DistressSSH+NCT06606249
Self-Help Plus for Distress in University Students
A study testing Self-Help Plus (SH+) and Psychological First Aid (PFA) in people with Psychological Distress and Psychological Well-Being, run by University of Padova at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Psychological Well-Being, Depression
- What is being tested?
- Self-Help Plus (SH+) and Psychological First Aid (PFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Mar 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Not yet recruiting
University of Bari "Aldo Moro"
Bari, Bari, 70121
Emilia Matera, Ph.D., 0805595258, emilia.matera@uniba.it
Lucia Margari, MD
- Recruiting
University of Padova
Padova, 35131
Marcella Lucente, PhD, +390498276595, marcella.lucente@unipd.it
Ioana Cristea, PhD
- Recruiting
Universita di Verona
Verona
Federica Patania, MSc, +039045 8124884, federica.patania@univr.it
Marianna Purgato, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Distress, Psychological Well-Being, Depression, Anxiety
- Being tested
- Self-Help Plus (SH+), Psychological First Aid (PFA)
- Keywords
- prevention, university students, academic deceit, emotion regulation
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help Plus (SH+)Behavioural
Also called Doing what matters in times of stress
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.
Psychological First Aid (PFA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Help Plus (SH+) | Experimental | 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. Receives: Behavioral: Self-Help Plus (SH+) |
| Psychological First Aid (PFA) | Active comparator | 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. Receives: Behavioral: Psychological First Aid (PFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, After the intervention, At 3 months after the intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, After the intervention, At 3 months after the intervention
Numbers of exams sustained
Self-reported number of exams sustained over the study period
Measured: 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)
Measured: Baseline, After the intervention, At 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will involve three centers (Padova, Verona, Bari). Randomization will be individual and stratified by the three recruiting center, with an allocation rate of 1:1:1. A centralized system (Redcap) will be used to generate the randomization schedule, using randomly permuted blocks of unequal size.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona, University of Bari Aldo Moro
- Responsible party
- Principal investigator, CRISTEA IOANA ALINA, University of Padova
- Investigators
- Ioana Cristea, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606249
- Sponsor's protocol ID
- 20224XSWRH
- Acronym
- SSH+
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress
- ClinicalTrials.gov ID
- NCT06606249
- Acronym / sponsor ID
- SSH+ / 20224XSWRH
- Conditions
- Psychological Distress, Psychological Well-Being, Depression, Anxiety
- Keywords
- prevention, university students, academic deceit, emotion regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Universita di Verona, University of Bari Aldo Moro
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study will involve three centers (Padova, Verona, Bari). Randomization will be individual and stratified by the three recruiting center, with an allocation rate of 1:1:1. A centralized system (Redcap) will be used to generate the randomization schedule, using randomly permuted blocks of unequal size.
| Arm | Type | Receives |
|---|---|---|
| Self-Help Plus (SH+) | Experimental | Behavioral: 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. |
| Psychological First Aid (PFA) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Help Plus (SH+)Also: Doing what matters in times of stressSelf-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. | Behavioural | Self-Help Plus (SH+) |
| 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. | Behavioural | Psychological First Aid (PFA) |
Primary outcome
Kessler psychological distress scale
Time frame: Baseline, After the intervention, At 3 months after the intervention
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.
5 secondary outcomes
Patient Health Questionnaire-9
Time frame: Baseline, After the intervention, At 3 months after the intervention
The Generalized Anxiety Disorder-7
Time frame: Baseline, After the intervention, At 3 months after the intervention
World Health Organization Well-Being Index
Time frame: Baseline, After the intervention, At 3 months after the intervention
Numbers of exams sustained
Time frame: Baseline, After the intervention, At 3 months after the intervention
Academic deceit survey
Time frame: Baseline, After the intervention, At 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ioana Cristea, PhD principal investigator
University of Padova
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Help Plus (SH+) and Psychological First Aid (PFA) in people with Psychological Distress and Psychological Well-Being, run by University of Padova at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioana Cristea, PhD (390498276595, ioanaalina.cristea@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler psychological distress scale (time frame: Baseline, After the intervention, At 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.