Self-Management and Recovery Technology Psychosocial Intervention Trial

Study Overview
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Brief Summary
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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).

Official Title
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Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services

Conditions
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Schizophrenia, Affective Disorders, Psychotic, Psychotic Disorders

Intervention / Treatment
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* Behavioral: Health intervention
* Behavioral: Social intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health intervention<br>+ treatment as usual | Behavioral: Health intervention<br>* 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.<br>|
| Active Comparator: Social intervention<br>+ treatment as usual | Behavioral: Social intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Process of Recovery Questionnaire (QPR) | Assesses personal recovery | Baseline, 3, 6 and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scales (PANSS) | Assesses psychotic symptomatology | Baseline, 3, 6 and 9 months | 
| Change in Subjective Experience of Psychosis Scale (SEPS) | Assesses subjective impact of psychotic symptoms | Baseline, 3, 6 and 9 months | 
| Change in Depression Anxiety Stress Scale (DASS-21) | Assesses emotional symptoms | Baseline, 3, 6 and 9 months | 
| Change in Assessment of Quality of Life 8dimension (AQol8d) | Assesses quality of life | Baseline, 3, 6 and 9 months | 
| Change in Resource Use Questionnaire | Measure of health service use | Baseline, 3, 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Schizophrenia, Self-management, Recovery, Tablet computer, Digital health, Internet, Online, Peer support