SMARTTherapy: Self-Management and Recovery Technology Psychosocial Intervention Trial

Sponsor

Swinburne University of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02474524

Collaborator

The Alfred (Other), St Vincent's Hospital Melbourne (Other), Melbourne Health (Other), Mental Illness Fellowship of Victoria (Other), Mind Australia (Other), La Trobe University (Other), Deakin University (Other), Austin Health (Other), Neami National (Other), Peninsula Health (Other), Eastern Health (Other), EACH (Other)

148

Enrollment

Locations

Arms

Actual Duration (Months)

14.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Affective Disorders, Psychotic Psychotic Disorders	Behavioral: Health intervention Behavioral: Social intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Process of Recovery Questionnaire (QPR) [Baseline, 3, 6 and 9 months]
Assesses personal recovery

Secondary Outcome Measures

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

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EACH	Eastern Melbourne	Victoria	Australia
2	Eastern Health	Eastern Melbourne	Victoria	Australia
3	Mental Illness Fellowship of Victoria	Fairfield	Victoria	Australia	3078
4	St Vincent's Health mental health services	Fitzroy	Victoria	Australia	3065
5	Peninsula Health	Frankston	Victoria	Australia
6	Austin Health	Heidelberg	Victoria	Australia	3084
7	Mind Australia	Heidelberg	Victoria	Australia	3084
8	Alfred Health mental health services	Melbourne	Victoria	Australia	3004
9	Neami National	Melbourne	Victoria	Australia
10	North Western Mental Health	Melbourne	Victoria	Australia