Clinical trial NCT02474524: Self-Management and Recovery Technology Psychosocial Intervention Trial
Official title: Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Affective Disorders, Psychotic
Psychotic Disorders
Keywords: Psychosis
Schizophrenia
Self-management
Recovery
Tablet computer
Digital health
Internet
Online
Peer support
Lead sponsor: Swinburne University of Technology
Sponsor class: OTHER
Collaborators: name: The Alfred
name: St Vincent's Hospital Melbourne
name: Melbourne Health
name: Mental Illness Fellowship of Victoria
name: Mind Australia
name: La Trobe University
name: Deakin University
name: Austin Health
name: Neami National
name: Peninsula Health
name: Eastern Health
name: EACH
First posted: 2015-06-17
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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;

Primary outcomes:
measure: Change in Process of Recovery Questionnaire (QPR)
timeFrame: Baseline, 3, 6 and 9 months
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scales (PANSS)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Subjective Experience of Psychosis Scale (SEPS)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Depression Anxiety Stress Scale (DASS-21)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Assessment of Quality of Life 8dimension (AQol8d)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Resource Use Questionnaire
timeFrame: Baseline, 3, 6 and 9 months
Other outcomes:
measure: Change in Self-Efficacy for Personal Recovery Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in General Self-Efficacy Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Schizophrenia Hope Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in UCLA Loneliness Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Internalised Stigma of Mental Illness Scale
timeFrame: Baseline, 3, 6 and 9 months
Locations:
city: Eastern Melbourne
country: Australia
facility: EACH
state: Victoria
city: Eastern Melbourne
country: Australia
facility: Eastern Health
state: Victoria
city: Fairfield
country: Australia
facility: Mental Illness Fellowship of Victoria
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Health mental health services
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Heidelberg
country: Australia
facility: Mind Australia
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health mental health services
state: Victoria
city: Melbourne
country: Australia
facility: Neami National
state: Victoria
city: Melbourne
country: Australia
facility: North Western Mental Health
state: Victoria
Study officials:
affiliation: Swinburne University of Technology/Alfred Health
name: Neil Thomas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.