Online social support for third level students - A pilot feasibility trial of the PSYCHE-MOST intervention.
| ISRCTN | ISRCTN15520701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15520701 |
| Secondary identifying numbers | RL-2020-007 |
- Submission date
- 19/04/2024
- Registration date
- 16/07/2024
- Last edited
- 16/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In many European countries, a significant portion of young adults engage in some form of education until their early twenties. A 2017 study conducted by the World Health Organization (WHO) involving approximately 14,000 students across eight countries, including Northern Ireland, revealed that around one in three individuals exhibited symptoms indicative of at least one common mental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), such as anxiety, mood disorders, or substance-related disorders.
With a noticeable increase in individuals seeking help for mental health concerns in recent times, digital health interventions—mental health support delivered through web-based or mobile-based platforms—hold significant promise in enhancing outcomes, broadening access, and addressing the growing demand for mental health services.
One such approach aimed at enhancing mental health recovery among young adults is Moderated Online Social Therapy (MOST), as proposed by Alvarez-Jimenez and colleagues in 2021. Initially developed as a digital mental health platform available via both web interface and dedicated app, MOST offers a low-intensity, cost-effective, and engaging method to sustain the benefits of specialized Early Intervention for Psychosis (EIP) services. Studies have shown its effectiveness in facilitating return to education and employment while reducing the need for emergency care. It has also undergone a trial involving young individuals aged 12 to 25 who sought help for mental health issues.
MOST comprises evidence-based online therapy content supplemented by therapist interaction, alongside a community feature resembling a Facebook-style platform, supported and moderated by peer support workers.
The objective of the current study is twofold: firstly, to assess the feasibility and acceptability of MOST among individuals who recently accessed a university counseling service, and secondly, to provide preliminary data on the effectiveness of MOST, laying the groundwork for a definitive randomized controlled trial.
Who can participate?
Adults aged 18 - 35 years, self reporting mental health difficulties of longer than one year in duration.
What does the study involve?
The study involves participating in a 26 week online digital intervention that consists of a therapy journey supported by fortnightly contact with a clinician, and an online social community supported by fortnightly contact with peer support workers.
What are the possible benefits and risks of participating?
The potential benefits are to wellbeing (e.g. reduction of clinical symptoms of anxiety/low mood) and improvement of social function. No risks have been identified to date with participation. In addition, participants complete an assessment battery at baseline, 3months and 6 months.
Where is the study run from?
University of Galway (Ireland)
When is the study starting and how long is it expected to run for?
September 2019 to December 2025
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
Prof Gary Donohoe, gary.donohoe@universityofgalway.ie
Contact information
Public, Scientific, Principal Investigator
School of Psychology, University of Galway, University Road
Galway
H912TK33
Ireland
 ORCID ID |
0000-0003-3037-7426 |
|---|---|
| Phone | +353 91495122 |
| gary.donohoe@universityofgalway.ie |
Study information
| Study design | Interventional pilot feasibility single center randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Improving Psychosocial Supports in youth mental health (PSYCHE) - A pilot feasibility randomised controlled trial of Moderated Online Social Therapy (MOST) for improving social function in third level students |
| Study acronym | PSYCHE-MOST |
| Study objectives | The trial explores the feasibility and acceptability of delivering MOST to help-seeking university students who have recently attended student counselling for the purposes of improving social function. The main study hypothesis is that (a) it will be possible to recruit n=60 and retain a majority of these at follow up. |
| Ethics approval(s) |
Approved 14/10/2020, Galway University Hospital Clinical Research Ethics Committee (Room 2, 2nd Floor, HR building, Merlin Park, Galway, H91N973, Ireland; +353 - 91 - 731990; colette.collins@hse.ie), ref: CA2468 |
| Health condition(s) or problem(s) studied | Mental health difficulties in third level students |
| Intervention | This trial is a pilot randomised controlled study recruiting young adults aged 18-35 years from a university student counselling service. The trial explores the feasibility, acceptability, and effectiveness of delivering MOST to participants who attended student counselling. MOST (The intervention being assessed) consists of (1) Interactive online therapy modules based on third wave cognitive behavioural therapy and primarily targeting social functioning by e.g., fostering self-efficacy (identifying personal strengths based on the strengths-based framework), positive emotions and subjective well-being (e.g., practicing mindfulness and self-compassion), or positive connections with others (e.g., focusing on empathy skills). Completing this therapy journey is supported by clinicians available by telephone/video chat on a for fortnightly basis. (2) An online social network or ‘Café’ to foster social support. Participants are encouraged to communicate with one another and with peer and expert moderators. This is moderated by clinicians and led by ‘peer-support workers’ with lived experience and informed by the evidence-based problem-solving framework. A further feature of MOST is an online group function to enable users to nominate issues (e.g., ‘how to break through shyness and make new friends?’), which are discussed in moderated groups through structured phases (e.g., brainstorming, pros and cons and wrap-up). The intervention is 26 weeks duration. The follow up periods are 3 and 6 months post baseline. Randomisation is based on the sealed envelope online tool. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility outcomes: Rates of recruitment and retention recorded using patient records at baseline, 3 months (12 weeks) and 6 months (26 weeks). |
| Secondary outcome measures | Measured at baseline, 3 months (12 weeks) and 6 months (26 weeks) based on interview with the participant: Demographic/Clinical measures: 1. Assessment interview (Demographic and clinical info) 2. DUDIT (Drug use) 3. AUDIT (Alcohol use) 4. Generalised Anxiety Disorder Assessment (GAD-7) 5. Patient Health Questionnaire (PHQ-9) 6. Time Use Survey 7. Social and Occupational Functioning Assessment Scale (SOFAS) 8. UCLA Loneliness scale Cognition measures: 9. Reading the Eyes in the Mind 10. Test of premorbid functioning (TOPF) 11. Logical Memory (WMS) |
| Overall study start date | 01/09/2019 |
| Completion date | 30/12/2025 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged between 18 and 35 years of age, 2. Clinically stable and having the ability to give consent. 3. Self-reporting mental health difficulties of longer than one year in duration. |
| Key exclusion criteria | 1. History of organic impairment (including IQ <70), or history of a head injury with loss of consciousness > 5-minute duration, 2. Drug or alcohol dependent. |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Galway
H91TK33
Ireland
Sponsor information
University/education
University road
Galway
H91TK33
Ireland
| Phone | +353 91 524411 |
|---|---|
| aoife.mckinley@universityofgalway.ie | |
| Website | https://www.universityofgalway.ie |
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the study PI, Prof Gary Donohoe, gary.donohoe@universityofgalway.ie |
Editorial Notes
19/04/2024: Trial's existence confirmed by Galway University Hospital Clinical Research Ethics Committee.
