Self-Management and Recovery Technology Psychosocial Intervention Trial

Schizophrenia Clinical Trial

— SMARTTherapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474524
• Other study ID #: 2014/119
• Secondary ID: MIRF33
• Status: Completed
• Phase: N/A
• First received: May 24, 2015
• Last updated: September 14, 2017
• Start date: January 1, 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Swinburne University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	EACH	Eastern Melbourne	Victoria
Australia	Eastern Health	Eastern Melbourne	Victoria
Australia	Mental Illness Fellowship of Victoria	Fairfield	Victoria
Australia	St Vincent's Health mental health services	Fitzroy	Victoria
Australia	Peninsula Health	Frankston	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Mind Australia	Heidelberg	Victoria
Australia	Alfred Health mental health services	Melbourne	Victoria
Australia	Neami National	Melbourne	Victoria
Australia	North Western Mental Health	Melbourne	Victoria

Sponsors (13)

Lead Sponsor	Collaborator
Swinburne University of Technology	Austin Health, Deakin University, EACH, Eastern Health, La Trobe University, Melbourne Health, Mental Illness Fellowship of Victoria, Mind Australia, Neami National, Peninsula Health, St Vincent's Hospital Melbourne, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Efficacy for Personal Recovery Scale		Baseline, 3, 6 and 9 months
Other	Change in General Self-Efficacy Scale		Baseline, 3, 6 and 9 months
Other	Change in Schizophrenia Hope Scale		Baseline, 3, 6 and 9 months
Other	Change in UCLA Loneliness Scale		Baseline, 3, 6 and 9 months
Other	Change in Internalised Stigma of Mental Illness Scale		Baseline, 3, 6 and 9 months
Primary	Change in Process of Recovery Questionnaire (QPR)	Assesses personal recovery	Baseline, 3, 6 and 9 months
Secondary	Change in Positive and Negative Syndrome Scales (PANSS)	Assesses psychotic symptomatology	Baseline, 3, 6 and 9 months
Secondary	Change in Subjective Experience of Psychosis Scale (SEPS)	Assesses subjective impact of psychotic symptoms	Baseline, 3, 6 and 9 months
Secondary	Change in Depression Anxiety Stress Scale (DASS-21)	Assesses emotional symptoms	Baseline, 3, 6 and 9 months
Secondary	Change in Assessment of Quality of Life 8dimension (AQol8d)	Assesses quality of life	Baseline, 3, 6 and 9 months
Secondary	Change in Resource Use Questionnaire	Measure of health service use	Baseline, 3, 6 and 9 months