CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis
NCT04180709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-08-15
Summary
Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery.
This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) or Early Intervention in Psychosis Services (EIS), in Norfolk and Suffolk NHS Foundation Trust (NSFT). Cameo CPFT and Early Intervention in Psychosis Services NSFT are services for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk and https://www.nsft.nhs.uk/adults/service/early-intervention-in-psychosis-services-norfolk-and-waveney-103/). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their early intervention team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.
Conditions
- Psychotic Disorders
- Psychosis
- Sleep
Interventions
- DEVICE
-
Sleepio
Sleepio is an online cognitive behavioural therapy (CBT) based intervention designed to treat insomnia, conducted is 6 sessions. The program is an automated media-rich web-based application that is driven dynamically by baseline, adherence, performance and progress data. At the beginning of each session The Prof conducts a progressive review with the participant exploring the diary data submitted the week prior that includes sleep status and pattern, as well as progress based on goals previously set by the participant. The information, support and advice are personally tailored based on underlying algorithms.
Sponsors & Collaborators
-
Cambridgeshire and Peterborough NHS Foundation Trust
collaborator OTHER -
Cambridge Cognition Ltd
collaborator INDUSTRY -
Big Health Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Peter B Jones, PhD MD · University of Cambridge
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-30
- Primary Completion
- 2023-07-31
- Completion
- 2023-07-31
Countries
- United Kingdom
Study Locations
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