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Self-Management and Recovery Technology Psychosocial Intervention Trial (SMARTTherapy)

Primary Purpose

Schizophrenia, Affective Disorders, Psychotic, Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Health intervention
Social intervention
Sponsored by
Swinburne University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychosis, Schizophrenia, Self-management, Recovery, Tablet computer, Digital health, Internet, Online, Peer support

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • EACH
  • Eastern Health
  • Mental Illness Fellowship of Victoria
  • St Vincent's Health mental health services
  • Peninsula Health
  • Austin Health
  • Mind Australia
  • Alfred Health mental health services
  • Neami National
  • North Western Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health intervention

Social intervention

Arm Description

+ treatment as usual

+ treatment as usual

Outcomes

Primary Outcome Measures

Change in Process of Recovery Questionnaire (QPR)
Assesses personal recovery

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2015
Last Updated
September 14, 2017
Sponsor
Swinburne University of Technology
Collaborators
The Alfred, St Vincent's Hospital Melbourne, Melbourne Health, Mental Illness Fellowship of Victoria, Mind Australia, La Trobe University, Deakin University, Austin Health, Neami National, Peninsula Health, Eastern Health, EACH
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1. Study Identification

Unique Protocol Identification Number
NCT02474524
Brief Title
Self-Management and Recovery Technology Psychosocial Intervention Trial
Acronym
SMARTTherapy
Official Title
Psychosocial Intervention Using Online Resources to Promote Personal Recovery in Users of Specialist Mental Health Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swinburne University of Technology
Collaborators
The Alfred, St Vincent's Hospital Melbourne, Melbourne Health, Mental Illness Fellowship of Victoria, Mind Australia, La Trobe University, Deakin University, Austin Health, Neami National, Peninsula Health, Eastern Health, EACH

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Affective Disorders, Psychotic, Psychotic Disorders
Keywords
Psychosis, Schizophrenia, Self-management, Recovery, Tablet computer, Digital health, Internet, Online, Peer support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health intervention
Arm Type
Experimental
Arm Description
+ treatment as usual
Arm Title
Social intervention
Arm Type
Active Comparator
Arm Description
+ treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Health intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in Process of Recovery Questionnaire (QPR)
Description
Assesses personal recovery
Time Frame
Baseline, 3, 6 and 9 months
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scales (PANSS)
Description
Assesses psychotic symptomatology
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Subjective Experience of Psychosis Scale (SEPS)
Description
Assesses subjective impact of psychotic symptoms
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Depression Anxiety Stress Scale (DASS-21)
Description
Assesses emotional symptoms
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Assessment of Quality of Life 8dimension (AQol8d)
Description
Assesses quality of life
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Resource Use Questionnaire
Description
Measure of health service use
Time Frame
Baseline, 3, 6 and 9 months
Other Pre-specified Outcome Measures:
Title
Change in Self-Efficacy for Personal Recovery Scale
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in General Self-Efficacy Scale
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Schizophrenia Hope Scale
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in UCLA Loneliness Scale
Time Frame
Baseline, 3, 6 and 9 months
Title
Change in Internalised Stigma of Mental Illness Scale
Time Frame
Baseline, 3, 6 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Thomas
Organizational Affiliation
Swinburne University of Technology/Alfred Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
EACH
City
Eastern Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Eastern Health
City
Eastern Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Mental Illness Fellowship of Victoria
City
Fairfield
State/Province
Victoria
ZIP/Postal Code
3078
Country
Australia
Facility Name
St Vincent's Health mental health services
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peninsula Health
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Mind Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Health mental health services
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Neami National
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
North Western Mental Health
City
Melbourne
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27604363
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.
Results Reference
derived

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Self-Management and Recovery Technology Psychosocial Intervention Trial

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