Self-Management and Recovery Technology Psychosocial Intervention Trial
SMARTTherapy
Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
2 other identifiers
interventional
148
1 country
10
Brief 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). 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jan 2015
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedSeptember 15, 2017
September 1, 2017
2.4 years
May 24, 2015
September 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Process of Recovery Questionnaire (QPR)
Assesses personal recovery
Baseline, 3, 6 and 9 months
Secondary Outcomes (5)
Change in Positive and Negative Syndrome Scales (PANSS)
Baseline, 3, 6 and 9 months
Change in Subjective Experience of Psychosis Scale (SEPS)
Baseline, 3, 6 and 9 months
Change in Depression Anxiety Stress Scale (DASS-21)
Baseline, 3, 6 and 9 months
Change in Assessment of Quality of Life 8dimension (AQol8d)
Baseline, 3, 6 and 9 months
Change in Resource Use Questionnaire
Baseline, 3, 6 and 9 months
Other Outcomes (5)
Change in Self-Efficacy for Personal Recovery Scale
Baseline, 3, 6 and 9 months
Change in General Self-Efficacy Scale
Baseline, 3, 6 and 9 months
Change in Schizophrenia Hope Scale
Baseline, 3, 6 and 9 months
- +2 more other outcomes
Study Arms (2)
Health intervention
EXPERIMENTAL\+ treatment as usual
Social intervention
ACTIVE COMPARATOR\+ treatment as usual
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swinburne University of Technologylead
- The Alfredcollaborator
- St Vincent's Hospital Melbournecollaborator
- Melbourne Healthcollaborator
- Mental Illness Fellowship of Victoriacollaborator
- Mind Australiacollaborator
- La Trobe Universitycollaborator
- Deakin Universitycollaborator
- Austin Healthcollaborator
- Neami Nationalcollaborator
- Peninsula Healthcollaborator
- Eastern Healthcollaborator
- EACHcollaborator
Study Sites (10)
EACH
Eastern Melbourne, Victoria, Australia
Eastern Health
Eastern Melbourne, Victoria, Australia
Mental Illness Fellowship of Victoria
Fairfield, Victoria, 3078, Australia
St Vincent's Health mental health services
Fitzroy, Victoria, 3065, Australia
Peninsula Health
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Mind Australia
Heidelberg, Victoria, 3084, Australia
Alfred Health mental health services
Melbourne, Victoria, 3004, Australia
Neami National
Melbourne, Victoria, Australia
North Western Mental Health
Melbourne, Victoria, Australia
Related Publications (1)
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.
PMID: 27604363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Thomas
Swinburne University of Technology/Alfred Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2015
First Posted
June 17, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
September 15, 2017
Record last verified: 2017-09