Early signs monitoring to prevent relapse and promote wellbeing, engagement and recovery

Conditions

Schizophrenia Mental and Behavioural Disorders Schizophrenia

Andrew Gumley, Simon Bradstreet, John Ainsworth, Stephanie Allan, Mario Álvarez‐Jiménez et al. (30 authors)

Health Technology Assessment2022-05-0140 citations

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support

Andrew Gumley, Simon Bradstreet, John Ainsworth, Stephanie Allan, Mario Álvarez‐Jiménez et al. (38 authors)

JMIR Research Protocols2020-01-0946 citations

10.2196/15058

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

Stephanie Allan, Hamish J. McLeod, Simon Bradstreet, Sara A. Beedie, Bethany Moir et al. (9 authors)

JMIR Research Protocols2019-09-2319 citations

10.2196/15634

Developing a Hypothetical Implementation Framework of Expectations for Monitoring Early Signs of Psychosis Relapse Using a Mobile App: Qualitative Study

Stephanie Allan, Simon Bradstreet, Hamish J. McLeod, John Farhall, Maria Lambrou et al. (9 authors)

Journal of Medical Internet Research2019-07-1954 citations

10.2196/14366

Interventions

Participating CMHTs will be randomized to the EMPOWER Relapse Prevention Intervention or to continue their Treatment as Usual approach to care. EMPOWER Relapse Prevention involves Men

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Service users of participating CMHT's: 1. Aged 16 years or over 2. In contact with a local community based services 3. Have been admitted to a psychiatric in-patient service at least once in the previous two years for a relapse of psychosis 4. A diagnosis of schizophrenia spectrum disorder (DSM-V) 5. Able to provide informed consent as adjudged by the care co-ordinator or if in doubt the responsible consultant. Carers who are nominated by eligible service users who provide informed consent will also be approached for their inclusion in the study. Service users can also nominate proxy-carers if they do not have a trusted other (e.g., care co-ordinator, keyworker, support worker).

Exclusion criteria

Exclusion criteria: Participants who do not meet the inclusion criteria.

Design outcomes

Primary

Measure	Time frame
1. The proportion of eligible and willing service users who then consent to enter the trial at at the end of the recruitment period 2. The proportion of service users continuing in the study at 3, 6 and 12 months 3. The proportion of service users completing >33% EWS datasets at 3, 6 and 12 months 4. The number of times data are accessed and number of times data shared by service users with mental health staff and their carers at 3, 6 and 12 months 5. The self-reported acceptability and usability of EMPOWER using a purposely developed questionnaire which will be derived from existing measures at 3, 6 and 12 months 6. The number of times mental health staff discuss service users' EWS data at 3, 6 and 12 months 7. The number of times service users has seek help from mental health staff at 3, 6 and 12-months 8. The number of times service users has activate the relapse prevention pathway at 3, 6 and 12 months 9. The number of times EMPOWER triggers a change in management (e.g. appointment brought forward, medication change) at 3, 6 and 12 months 10. Fear of Relapse is measured using the Fear of Recurrence Scale at 3, 6 and 12 months 11. Total number serious adverse events (relapse, rehospitalisation, suicide and attempted suicide) are recorded at 3, 6 and 12 months	—

Measure

Time frame

1. The proportion of eligible and willing service users who then consent to enter the trial at at the end of the recruitment period 2. The proportion of service users continuing in the study at 3, 6 and 12 months 3. The proportion of service users completing >33% EWS datasets at 3, 6 and 12 months 4. The number of times data are accessed and number of times data shared by service users with mental health staff and their carers at 3, 6 and 12 months 5. The self-reported acceptability and usability of EMPOWER using a purposely developed questionnaire which will be derived from existing measures at 3, 6 and 12 months 6. The number of times mental health staff discuss service users' EWS data at 3, 6 and 12 months 7. The number of times service users has seek help from mental health staff at 3, 6 and 12-months 8. The number of times service users has activate the relapse prevention pathway at 3, 6 and 12 months 9. The number of times EMPOWER triggers a change in management (e.g. appointment brought forward, medication change) at 3, 6 and 12 months 10. Fear of Relapse is measured using the Fear of Recurrence Scale at 3, 6 and 12 months 11. Total number serious adverse events (relapse, rehospitalisation, suicide and attempted suicide) are recorded at 3, 6 and 12 months

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Secondary

Measure	Time frame
Service Users Participants: 1. Rate of relapse observed between the two treatment conditions over 12 months 2. Patterns of recovery (Questionnaire for Personal Recovery), empowerment (The Empowerment Rating Scale) and coercion (MacArthur Perceived Coercions Scale) are measured at 3, 6 and 12 months 3. Patterns of interpersonal support are measured using the Sources of Support Scale and Perceived Criticism Scale at 3, 6 and 12 months 4. Functioning is measured using the Psychosis Attachment Measure at 3, 6 and 12 months 5. Patterns of service engagement are determined using the Working Alliance Inventory and Service Attachment Questionnaire at 3, 6 and 12 months 6. Patterns of psychiatric recovery are determined using the Positive and Negative Syndrome Scale and Calgary Depression Scale at 3, 6 and 12 months 7. Patterns of emotional recovery are determined using the Fear of Recurrence Scale, Hospital Anxiety and Depression Scale and Personal Beliefs about Illness - Revised questionnaires at 3, 6, and 12 months 8. Patterns of substance use are determined using the Time Line Follow Back for drugs and alcohol, Alcohol Use Disorder Identification Test, the Drug Abuse Screening Test (DAST) and the Cannabis User Disorders Identification Test - Revised questionnaires at 3, 6, and 12-months Carer Participants: Patterns of carer burden and distress are evaluated using the Involvement Evaluation Questionnaire at 3, 6 and 12-months. Mental Health Staff: Patterns of therapeutic alliance/service engagement are evaluated using the Service Engagement Scale and Working Alliance Scale at 3, 6 and 12 months.	—

Measure

Time frame

Service Users Participants: 1. Rate of relapse observed between the two treatment conditions over 12 months 2. Patterns of recovery (Questionnaire for Personal Recovery), empowerment (The Empowerment Rating Scale) and coercion (MacArthur Perceived Coercions Scale) are measured at 3, 6 and 12 months 3. Patterns of interpersonal support are measured using the Sources of Support Scale and Perceived Criticism Scale at 3, 6 and 12 months 4. Functioning is measured using the Psychosis Attachment Measure at 3, 6 and 12 months 5. Patterns of service engagement are determined using the Working Alliance Inventory and Service Attachment Questionnaire at 3, 6 and 12 months 6. Patterns of psychiatric recovery are determined using the Positive and Negative Syndrome Scale and Calgary Depression Scale at 3, 6 and 12 months 7. Patterns of emotional recovery are determined using the Fear of Recurrence Scale, Hospital Anxiety and Depression Scale and Personal Beliefs about Illness - Revised questionnaires at 3, 6, and 12 months 8. Patterns of substance use are determined using the Time Line Follow Back for drugs and alcohol, Alcohol Use Disorder Identification Test, the Drug Abuse Screening Test (DAST) and the Cannabis User Disorders Identification Test - Revised questionnaires at 3, 6, and 12-months Carer Participants: Patterns of carer burden and distress are evaluated using the Involvement Evaluation Questionnaire at 3, 6 and 12-months. Mental Health Staff: Patterns of therapeutic alliance/service engagement are evaluated using the Service Engagement Scale and Working Alliance Scale at 3, 6 and 12 months.

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Countries

Australia, Scotland, United Kingdom

Outcome results

None listed