Self-Management and Recovery Technology Psychosocial Intervention Trial

Not Applicable

Completed

• Conditions: Schizophrenia; Affective Disorders, Psychotic; Psychotic Disorders
• Interventions: Behavioral: Social intervention; Behavioral: Health intervention

• Registration Number: NCT02474524
• Lead Sponsor: Swinburne University of Technology

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-05-24
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-17
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social intervention	Social intervention	+ treatment as usual
Health intervention	Health intervention	+ treatment as usual

Primary Outcome Measures

Name	Time	Method
Change in Process of Recovery Questionnaire (QPR)	Baseline, 3, 6 and 9 months	Assesses personal recovery

Secondary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scales (PANSS)	Baseline, 3, 6 and 9 months	Assesses psychotic symptomatology
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
Change in Depression Anxiety Stress Scale (DASS-21)	Baseline, 3, 6 and 9 months	Assesses emotional symptoms
Change in Subjective Experience of Psychosis Scale (SEPS)	Baseline, 3, 6 and 9 months	Assesses subjective impact of psychotic symptoms

Trial Locations

Locations (10)

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

Alfred Health mental health services; 🇦🇺 Melbourne, Victoria, Australia

Neami National; 🇦🇺 Melbourne, Victoria, Australia

North Western Mental Health; 🇦🇺 Melbourne, Victoria, Australia

Mind Australia; 🇦🇺 Heidelberg, Victoria, Australia