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Completed

NCT Number: NCT02474524

Self-Management and Recovery Technology Psychosocial Intervention Trial

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).

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Key information

Conditions

Schizophrenia Affective Disorders, Psychotic Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EACH, Eastern Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Health intervention

Behavioral

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

Behavioral

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 outcomes

  1. Change in Process of Recovery Questionnaire (QPR)

    Time frame: Baseline, 3, 6 and 9 months

    Assesses personal recovery

Secondary outcomes

  1. Change in Positive and Negative Syndrome Scales (PANSS)

    Time frame: Baseline, 3, 6 and 9 months

    Assesses psychotic symptomatology

  2. Change in Subjective Experience of Psychosis Scale (SEPS)

    Time frame: Baseline, 3, 6 and 9 months

    Assesses subjective impact of psychotic symptoms

  3. Change in Depression Anxiety Stress Scale (DASS-21)

    Time frame: Baseline, 3, 6 and 9 months

    Assesses emotional symptoms

  4. Change in Assessment of Quality of Life 8dimension (AQol8d)

    Time frame: Baseline, 3, 6 and 9 months

    Assesses quality of life

  5. Change in Resource Use Questionnaire

    Time frame: Baseline, 3, 6 and 9 months

    Measure of health service use

Other outcomes

  1. Change in Self-Efficacy for Personal Recovery Scale

    Time frame: Baseline, 3, 6 and 9 months

  2. Change in General Self-Efficacy Scale

    Time frame: Baseline, 3, 6 and 9 months

  3. Change in Schizophrenia Hope Scale

    Time frame: Baseline, 3, 6 and 9 months

  4. Change in UCLA Loneliness Scale

    Time frame: Baseline, 3, 6 and 9 months

  5. Change in Internalised Stigma of Mental Illness Scale

    Time frame: Baseline, 3, 6 and 9 months

Sponsors and collaborators

Lead sponsor

Swinburne University of Technology

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: SMARTTherapy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2015
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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