Serious Mental IllnessNCT07025499
Piloting and Evaluation of a Group Intervention for People With Psychosis Designed to Boost Access and Usage of ICT
A study testing Group ICT Intervention in people with Serious Mental Illness, run by McMaster University at 1 site in Canada.
Trial summary
Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Group ICT Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2025to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific inclusion criteria for participants in this study will include being diagnosed with a psychotic disorder, living in the Hamilton area, ability to communicate in English, and having more than one episode of psychosis. Every effort will be made to recruit participants from study with HiREB approvals #17367 and #18549, as indicated in that study's previous consent form, for those that have consented to be contacted for future research.
Who cannot join
- Exclusion criteria include currently experiencing an acute psychotic episode or medical condition that would render them incapable of meaningfully participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N3K7
Jaclin Vozza, MScOT, PhD Candidate, 905-510-3095, whaleyja@mcmaster.ca
Jaclin Vozza, MScOT, PhD Candidate
About this study
Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program.
- Conditions
- Serious Mental Illness
- Being tested
- Group ICT Intervention
- Keywords
- Information and Communication Technology, Recovery, social connection, community participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ICT InterventionBehavioural
Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program.
| Study group | Role | What they receive |
|---|---|---|
| Information and Communication Technology Group Intervention | Experimental | Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program. Receives: Behavioral: Group ICT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews
The primary outcome is what participants will share regarding their experiences with the group intervention.
Measured: From end of group intervention to 3 months
Secondary outcomes (2)
Canadian Occupational Performance Measure (COPM)
Participants will write 1-3 goals regarding their access and use of technology, and rate their importance, satisfaction, and performance with these goals.
Measured: From enrolment to end of 7-week group
The Media and Technology Usage and Attitudes Scale (MTUAS)
Participants will rate their technology usage and attitudes towards technology
Measured: From enrolment to end of 7 week group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot evaluation
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Jaclin Whaley, McMaster University
- Investigators
- Rebecca Gewurtz, PhD, MScOT, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025499
- Sponsor's protocol ID
- 18839
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: COPM, MTUAS, qualitative interview themes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting and Evaluation of a Group Intervention for People With Psychosis Designed to Boost Access and Usage of ICT
- ClinicalTrials.gov ID
- NCT07025499
- Acronym / sponsor ID
- 18839
- Conditions
- Serious Mental Illness
- Keywords
- Information and Communication Technology, Recovery, social connection, community participation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2025 (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.
Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot evaluation
| Arm | Type | Receives |
|---|---|---|
| Information and Communication Technology Group Intervention | Experimental | Behavioral: Group ICT InterventionParticipants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Specific inclusion criteria for participants in this study will include being diagnosed with a psychotic disorder, living in the Hamilton area, ability to communicate in English, and having more than one episode of psychosis. Every effort will be made to recruit participants from study with HiREB approvals #17367 and #18549, as indicated in that study's previous consent form, for those that have consented to be contacted for future research.
Key exclusion criteria (1 listed)
- Exclusion criteria include currently experiencing an acute psychotic episode or medical condition that would render them incapable of meaningfully participating in the study.
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 |
|---|---|---|
| Group ICT InterventionParticipants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program. | Behavioural | Information and Communication Technology Group Intervention |
Primary outcome
Qualitative interviews
Time frame: From end of group intervention to 3 months
The primary outcome is what participants will share regarding their experiences with the group intervention.
2 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: From enrolment to end of 7-week group
The Media and Technology Usage and Attitudes Scale (MTUAS)
Time frame: From enrolment to end of 7 week group
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 17 Jun 2025.
- Individual participant dataSharing planned: Yes. COPM, MTUAS, qualitative interview themes
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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.
Rebecca Gewurtz, PhD, MScOT principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group ICT Intervention in people with Serious Mental Illness, run by McMaster University at 1 site in Canada.
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 1 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: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Jaclin Vozza, MScOT, PhD Candidate (905-510-3095, whaleyja@mcmaste.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: From end of group intervention to 3 months). 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 17 Jun 2025.