This trial is active, not recruiting.

Conditions schizophrenia, affective disorders, psychotic, psychotic disorders
Treatments health intervention, social intervention
Sponsor Swinburne University of Technology
Collaborator The Alfred
Start date January 2015
End date August 2017
Trial size 148 participants
Trial identifier NCT02474524, 2014/119, MIRF33


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
+ treatment as usual
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)
+ treatment as usual
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.

Primary Outcomes

Change in Process of Recovery Questionnaire (QPR)
time frame: Baseline, 3, 6 and 9 months

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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;

Additional Information

Official title Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
Principal investigator Neil Thomas
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Swinburne University of Technology.