Implementation of Digital CBT for Insomnia in First Episode Psychosis

NCT05050201 | Unknown

• 1 other identifier: GN21MH015
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This study uses mixed methods to investigate the implementation of digital cognitive behavioural therapy for insomnia (Sleepio) in a first episode of psychosis service (FEP). Interviews will be conducted with keyworker clinicians and service users to consider their expectations for digital sleep intervention. The rates of recruitment into the study, eligibility, completion of baseline measures, completion of the intervention sessions, attrition from the intervention and completion of follow up measures will be recorded. Interviews will be conducted with keyworker clinicians and service users to consider their experiences of digital sleep intervention. The primary outcome will be a logic model describing factors acting upon the implementation of Sleepio in this population. The investigators will provide signal data in relation to changes in insomnia severity, psychosis symptomatology, and general mental health.

Conditions

Insomnia; Psychosis; First Episode Psychosis

Keywords

insomnia; psychosis; first episode psychosis; digital CBT; CBT-I

Outcome Measures

Primary Outcomes (5)

• Implementation data - rates of consenting

  Rates of consenting and nonconsenting interested participants

  Across study timeline (8 months), across 10 weeks for Sleepio specific measures

• Implementation data - eligibility

  Number of eligible vs. ineligible participants and reasons for ineligibility

  8 months

• Implementation data - completion of measures

  Participant completion of measures assessment appointments and measures (ISI measure of insomnia severity, DASS-21 measure of mental wellbeing, R-GPTS measure of paranoia, SPEQ measure of hallucination, and Fear of Covid19). This outcome records whether or not these were completed by participants, whereas secondary outcomes 6-10 examine participant scores on these measures.

  8 months

• Implementation data - completion of intervention sessions

  Measures attrition from intervention by recording how many sessions of intervention were completed by participant.

  Across 10 weeks per participant

• Qualitative data

  Service user and clinician expectations and experiences of digital CBT-I intervention

  Across study timeline (8 months), across 12 weeks for service users (pre and post intervention)

Secondary Outcomes (5)

• Insomnia severity

  10 weeks

• Mental Wellbeing

  10 weeks

• Paranoia symptomatology

  10 weeks

• Hallucination symptomatology

  10 weeks

• Anxiety regarding Covid19

  10 weeks

Study Arms (1)

Sleepio Intervention

EXPERIMENTAL

Participants using the Sleepio application - access for 6 sessions, over 10 weeks

Device: Sleepio

Interventions

Sleepio DEVICE

Digital CBT application for insomnia

Sleepio Intervention

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Service users under the care of Esteem First Episode Psychosis Service in NHS GGC
• Potentially affected by Insomnia Disorder (defined by Sleep Condition Indicator-02 score ≤2)
• Who have access to a device they can use Sleepio on (a computer device with Safari or Google Chrome browser, or an iPhone device).

You may not qualify if:

• Moderate to severe learning disability
• Acute Psychosis (recent crisis contact or hospitalisation)
• Incapacity to provide informed consent
• Insufficient English to access intervention
• Organic impairment
• No access to a device which can be used for Sleepio intervention.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Big Health Inc.: collaborator

Study Sites (2)

Esteem North, NHS Greater Glasgow and Clyde

Glasgow, G213UW, United Kingdom

RECRUITING

Esteem South and Clyde, NHS Greater Glasgow and Clyde

Glasgow, G53 7TU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Andrew Gumley

  NHS Greater Glasgow and Clyde; University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine O'Neill - Senior Research Administrator

CONTACT

0141 314 4011; Elaine.O'Neill2@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participation is not masked - any service users who would like to participate may do so and their keyworker will be notified as a mandatory condition of consent
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All service users who would like to trial the Sleepio intervention will be able to do so.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: September 20, 2021
• Study Start: April 20, 2021
• Primary Completion: April 20, 2022
• Study Completion: September 30, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)