SchizophreniaSMARTTherapyNCT02474524
Self-Management and Recovery Technology Psychosocial Intervention Trial
A study testing Health intervention and Social intervention in people with Schizophrenia and Affective Disorders, Psychotic, run by Swinburne University of Technology at 10 sites in Australia.
Trial summary
This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Affective Disorders, Psychotic, Psychotic Disorders
- What is being tested?
- Health intervention and Social 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
- 148 participants
- Where
- 10 sitesAustralia
- Study dates
- 1 Jan 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of a functional psychotic disorder (schizophrenia-related disorder OR bipolar disorder or major depressive disorder with the presence of a severe episode with psychotic features within the past 2 years);
- sufficient fluency in English to make use of the resources;
- overall intellectual functioning within normal limits (WTAR estimated IQ>70);
- Exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
EACH
Eastern Melbourne, Victoria
Eastern Health
Eastern Melbourne, Victoria
Mental Illness Fellowship of Victoria
Fairfield, Victoria, 3078
St Vincent's Health mental health services
Fitzroy, Victoria, 3065
Peninsula Health
Frankston, Victoria
Austin Health
Heidelberg, Victoria, 3084
Mind Australia
Heidelberg, Victoria, 3084
Alfred Health mental health services
Melbourne, Victoria, 3004
Neami National
Melbourne, Victoria
North Western Mental Health
Melbourne, Victoria
About this study
Official title: Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). The overall research program is examining the therapeutic potential of using online (Internet-based) educational and multimedia resources in mental health services. It involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. It consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness.
This particular project (SMART-Therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. The intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. iPad) on which online materials can be viewed, and used to guide an interaction with the participant.
Read more
The randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the SMART website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). In each condition, there will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed pre-randomisation, and at 3, 6 and 9 months.
The primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).
- Being tested
- Health intervention, Social intervention
- Keywords
- Psychosis, Schizophrenia, Self-management, Recovery, Tablet computer, Digital health, Internet, Online, Peer support
- Medical subject headings
- Schizophrenia, Affective Disorders, Psychotic, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health interventionBehavioural
Participants will receive 8 50-minute sessions during a 3 month window with a mental health worker, in addition to their routine care. Sessions will be structured by the worker and participant using a tablet computer to view materials on mental health self-management and personal recovery on a dedicated website for the trial. These will include information, videos, audio and exercises. Online materials make particular use of videos featuring people with lived experience of psychosis discussing how they have dealt with issues in their recovery, and will allow users to post comments on videos and in a forum. Participants may access online materials both during intervention sessions and outside sessions using any Internet-enabled device.
Social interventionBehavioural
Participants will receive 8 50-minute sessions during a 3 month window with a mental health worker in addition to routine care (treatment as usual). The social intervention will utilise a computer tablet (i.e., iPad) servicing online resources to extend a manualised befriending intervention, based upon social interaction, designed to control for therapist contact and computer use. Each session will involve interaction about non-health related topics of interest to the participants, which will be facilitated by use of viewing online material related to these interests on a tablet computer as a prompt to conversation.
| Study group | Role | What they receive |
|---|---|---|
| Health intervention | Experimental | + treatment as usual Receives: Behavioral: Health intervention |
| Social intervention | Active comparator | + treatment as usual Receives: Behavioral: Social intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Process of Recovery Questionnaire (QPR)
Assesses personal recovery
Measured: Baseline, 3, 6 and 9 months
Secondary outcomes (5)
Change in Positive and Negative Syndrome Scales (PANSS)
Assesses psychotic symptomatology
Measured: Baseline, 3, 6 and 9 months
Change in Subjective Experience of Psychosis Scale (SEPS)
Assesses subjective impact of psychotic symptoms
Measured: Baseline, 3, 6 and 9 months
Change in Depression Anxiety Stress Scale (DASS-21)
Assesses emotional symptoms
Measured: Baseline, 3, 6 and 9 months
Change in Assessment of Quality of Life 8dimension (AQol8d)
Assesses quality of life
Measured: Baseline, 3, 6 and 9 months
Change in Resource Use Questionnaire
Measure of health service use
Measured: Baseline, 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start1 Jan 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swinburne University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred, St Vincent's Hospital Melbourne, Melbourne Health, Mental Illness Fellowship of Victoria, Mind Australia, La Trobe University, Deakin University, Austin Health, Neami National, Peninsula Health, Eastern Health, EACH
- Responsible party
- Sponsor
- Investigators
- Neil Thomas, Principal investigator, Swinburne University of Technology/Alfred Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474524
- Sponsor's protocol ID
- 2014/119
- Other IDs
- MIRF33
- Acronym
- SMARTTherapy
- Status last verified
- Sep 2017
- First submitted
- 24 May 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomas N, Farhall J, Foley F, Rossell SL, Castle D, Ladd E, Meyer D, Mihalopoulos C, Leitan N, Nunan C, Frankish R, Smark T, Farnan S, McLeod B, Sterling L, Murray G, Fossey E, Brophy L, Kyrios M. Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol. BMC Psychiatry. 2016 Sep 7;16(1):312. doi: 10.1186/s12888-016-1024-1.
PubMed 27604363
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
- ClinicalTrials.gov ID
- NCT02474524
- Acronym / sponsor ID
- SMARTTherapy / 2014/119
- Keywords
- Psychosis, Schizophrenia, Self-management, Recovery, Tablet computer, Digital health, Internet, Online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Swinburne University of TechnologyUniversity, hospital or other
- Collaborators
- The Alfred, St Vincent's Hospital Melbourne, Melbourne Health, Mental Illness Fellowship of Victoria, Mind Australia, La Trobe University, Deakin University, Austin Health, Neami National, Peninsula Health, Eastern Health, EACH
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Jun 2015 (estimated)
- 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.
This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). The overall research program is examining the therapeutic potential of using online (Internet-based) educational and multimedia resources in mental health services. It involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. It consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness.
This particular project (SMART-Therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. The intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. iPad) on which online materials can be viewed, and used to guide an interaction with the participant.
The randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the SMART website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). In each condition, there will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed pre-randomisation, and at 3, 6 and 9 months.
The primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health intervention | Experimental | Behavioral: Health intervention+ treatment as usual |
| Social intervention | Active comparator | Behavioral: Social intervention+ treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of a functional psychotic disorder (schizophrenia-related disorder OR bipolar disorder or major depressive disorder with the presence of a severe episode with psychotic features within the past 2 years);
- sufficient fluency in English to make use of the resources;
- overall intellectual functioning within normal limits (WTAR estimated IQ>70);
- Exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health interventionParticipants will receive 8 50-minute sessions during a 3 month window with a mental health worker, in addition to their routine care. Sessions will be structured by the worker and participant using a tablet computer to view materials on mental health self-management and personal recovery on a dedicated website for the trial. These will include information, videos, audio and exercises. Online materials make particular use of videos featuring people with lived experience of psychosis discussing how they have dealt with issues in their recovery, and will allow users to post comments on videos and in a forum. Participants may access online materials both during intervention sessions and outside sessions using any Internet-enabled device. | Behavioural | Health intervention |
| Social interventionParticipants will receive 8 50-minute sessions during a 3 month window with a mental health worker in addition to routine care (treatment as usual). The social intervention will utilise a computer tablet (i.e., iPad) servicing online resources to extend a manualised befriending intervention, based upon social interaction, designed to control for therapist contact and computer use. Each session will involve interaction about non-health related topics of interest to the participants, which will be facilitated by use of viewing online material related to these interests on a tablet computer as a prompt to conversation. | Behavioural | Social intervention |
Primary outcome
Change in Process of Recovery Questionnaire (QPR)
Time frame: Baseline, 3, 6 and 9 months
Assesses personal recovery
5 secondary outcomes
Change in Positive and Negative Syndrome Scales (PANSS)
Time frame: Baseline, 3, 6 and 9 months
Change in Subjective Experience of Psychosis Scale (SEPS)
Time frame: Baseline, 3, 6 and 9 months
Change in Depression Anxiety Stress Scale (DASS-21)
Time frame: Baseline, 3, 6 and 9 months
Change in Assessment of Quality of Life 8dimension (AQol8d)
Time frame: Baseline, 3, 6 and 9 months
Change in Resource Use Questionnaire
Time frame: Baseline, 3, 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 27604363Thomas N, Farhall J, Foley F, Rossell SL, Castle D, Ladd E, Meyer D, Mihalopoulos C, Leitan N, Nunan C, Frankish R, Smark T, Farnan S, McLeod B, Sterling L, Murray G, Fossey E, Brophy L, Kyrios M. Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol. BMC Psychiatry. 2016 Sep 7;16(1):312. doi: 10.1186/s12888-016-1024-1.
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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. This study is not recruiting at the moment.
Neil Thomas principal investigator
Swinburne University of Technology/Alfred Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health intervention and Social intervention in people with Schizophrenia and Affective Disorders, Psychotic, run by Swinburne University of Technology at 10 sites in Australia.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Process of Recovery Questionnaire (QPR) (time frame: Baseline, 3, 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474524, which also lists 1 linked publication.
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 15 Sep 2017.