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

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 Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Affective Disorders, Psychotic
• Intervention / Treatment: Behavioral: Health intervention; Behavioral: Social intervention

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Eastern Melbourne, Victoria, Australia
      • EACH
    • Eastern Melbourne, Victoria, Australia
      • Eastern Health
    • Fairfield, Victoria, Australia, 3078
      • Mental Illness Fellowship of Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Health mental health services
    • Frankston, Victoria, Australia
      • Peninsula Health
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Heidelberg, Victoria, Australia, 3084
      • Mind Australia
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health mental health services
    • Melbourne, Victoria, Australia
      • Neami National
    • Melbourne, Victoria, Australia
      • North Western Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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);

Exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health 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.
Active Comparator: Social intervention; + treatment as usual	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
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
Change in UCLA Loneliness Scale	Baseline, 3, 6 and 9 months
Change in Internalised Stigma of Mental Illness Scale	Baseline, 3, 6 and 9 months

Collaborators and Investigators

• Sponsor: Swinburne University of Technology
• Collaborators: Melbourne Health; The Alfred; St Vincent's Hospital Melbourne; Austin Health; Eastern Health; Deakin University; La Trobe University; Peninsula Health; Mental Illness Fellowship of Victoria; Mind Australia; Neami National; EACH
• Investigators: Principal Investigator: Neil Thomas, Swinburne University of Technology/Alfred Health

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 24, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Recovery; Self-management; Internet; Online; Digital health; Peer support; Tablet computer
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Mood Disorders; Affective Disorders, Psychotic
• Other Study ID Numbers: 2014/119; MIRF33 (Other Grant/Funding Number: Victorian Department of Health Mental Illness Research Fund)