Online social support for early psychosis - A pilot feasibility trial of the PSYCHE-MOST intervention.
| ISRCTN | ISRCTN10528454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10528454 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RL-2020-007 |
| Sponsor | Ollscoil na Gaillimhe – University of Galway |
| Funder | Health Research Board |
- Submission date
- 09/08/2024
- Registration date
- 05/12/2024
- Last edited
- 05/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
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). Initially developed as a digital mental health platform available via both a web interface and a dedicated app, MOST offers a low-intensity, cost-effective, and engaging method to sustain or augment 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 years old 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 are currently attending an EIP service, and secondly, to provide preliminary data on the effectiveness of MOST, laying the groundwork for a definitive randomized controlled trial.
Who can participate?
Patients aged between 18 and 35 years old who are clinically stable, able to give consent and self-reporting mental health difficulties of longer than one year in duration
What does the study involve?
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 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 in duration with follow-ups at 3 and 6 months.
What are the possible benefits and risks of participating?
Possible benefits include (1) a reduction in clinical symptoms of anxiety and low mood, (2) opportunities to receive support from an online therapist while completing a CBT-informed online therapy intervention, and (3) opportunities to receive peer support from a peer support worker.
Possible, risks include (1) distress caused by participating in the assessment, which asks questions about early childhood adversity and clinical symptom severity, and (2) low-level distress caused by participating in an online intervention that may not meet the psychological needs of the individual.
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?
Dr Gary Donohoe, gary.donohoe@universityofgalway.ie
Contact information
Public, Scientific, Principal investigator
School of Psychology, University of Galway
University road
Galway
H91Tk33
Ireland
 ORCID ID |
0000-0003-3037-7426 |
|---|---|
| Phone | +3530866008405 |
| gary.donohoe@nuigalway.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional pilot feasibility multi-center randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 early psychosis |
| Study acronym | PSYCHE-MOST-EIP |
| Study objectives | The trial explores the feasibility and acceptability of delivering MOST to individuals who are currently attending early intervention for psychosis services in Ireland. The main study hypothesis is that (a) it will be possible to recruit n=30 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 | Psychosis |
| Intervention | This trial is a pilot randomised controlled study recruiting patients attending an early intervention for psychosis service in Ireland. The trial explores the feasibility, acceptability, and effectiveness of delivering MOST to participants who attended the EIP service. 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 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 control group receives treatment as usual, defined as continuing to receive any care that they were receiving prior to the intervention. 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(s) |
Feasibility outcomes: Rates of recruitment and retention measured using data recorded in patient records at baseline, 3 months (12 weeks) and 6 months (26 weeks) |
| Key secondary outcome measure(s) |
The following secondary outcome measures will be measured during interviews with the participant at baseline, 3 months (12 weeks) and 6 months (26 weeks): |
| Completion date | 30/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged between 18 and 35 years old 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 centres
Sligo
F91 X92V
Ireland
Galway
H91YR71
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/08/2024: Study's existence confirmed by the Galway University Hospital Clinical Research Ethics Committee.
