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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02474524




Registration number
NCT02474524
Ethics application status
Date submitted
24/05/2015
Date registered
17/06/2015
Date last updated
15/09/2017

Titles & IDs
Public title
Self-Management and Recovery Technology Psychosocial Intervention Trial
Scientific title
Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
Secondary ID [1] 0 0
MIRF33
Secondary ID [2] 0 0
2014/119
Universal Trial Number (UTN)
Trial acronym
SMARTTherapy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Affective Disorders, Psychotic 0 0
Psychotic Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Health intervention
BEHAVIORAL - Social intervention

Experimental: Health intervention - + treatment as usual

Active comparator: Social intervention - + treatment as usual


BEHAVIORAL: Health intervention
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.

BEHAVIORAL: Social intervention
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Process of Recovery Questionnaire (QPR)
Timepoint [1] 0 0
Baseline, 3, 6 and 9 months
Secondary outcome [1] 0 0
Change in Positive and Negative Syndrome Scales (PANSS)
Timepoint [1] 0 0
Baseline, 3, 6 and 9 months
Secondary outcome [2] 0 0
Change in Subjective Experience of Psychosis Scale (SEPS)
Timepoint [2] 0 0
Baseline, 3, 6 and 9 months
Secondary outcome [3] 0 0
Change in Depression Anxiety Stress Scale (DASS-21)
Timepoint [3] 0 0
Baseline, 3, 6 and 9 months
Secondary outcome [4] 0 0
Change in Assessment of Quality of Life 8dimension (AQol8d)
Timepoint [4] 0 0
Baseline, 3, 6 and 9 months
Secondary outcome [5] 0 0
Change in Resource Use Questionnaire
Timepoint [5] 0 0
Baseline, 3, 6 and 9 months

Eligibility
Key inclusion criteria
1. 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);
2. sufficient fluency in English to make use of the resources;
3. overall intellectual functioning within normal limits (WTAR estimated IQ>70);
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2017
Sample size
Target
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
EACH - Eastern Melbourne
Recruitment hospital [2] 0 0
Eastern Health - Eastern Melbourne
Recruitment hospital [3] 0 0
Mental Illness Fellowship of Victoria - Fairfield
Recruitment hospital [4] 0 0
St Vincent's Health mental health services - Fitzroy
Recruitment hospital [5] 0 0
Peninsula Health - Frankston
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Mind Australia - Heidelberg
Recruitment hospital [8] 0 0
Alfred Health mental health services - Melbourne
Recruitment hospital [9] 0 0
Neami National - Melbourne
Recruitment hospital [10] 0 0
North Western Mental Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Eastern Melbourne
Recruitment postcode(s) [2] 0 0
3078 - Fairfield
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St Vincent's Hospital Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Melbourne Health
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Mental Illness Fellowship of Victoria
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Mind Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
La Trobe University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Deakin University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Government body
Name [8] 0 0
Austin Health
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Neami National
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Government body
Name [10] 0 0
Peninsula Health
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Eastern Health
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
EACH
Address [12] 0 0
Country [12] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02474524
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Neil Thomas
Address 0 0
Swinburne University of Technology/Alfred Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02474524