CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis

NCT04180709 | Completed

• 4 other identifiers: M00915RNAG-52122410119/EE/0352
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cognition; Social Recovery; Immunopsychiatry; Daily function; Sleep disturbances; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study

  WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and \>20 suggest moderately severe functional impairment (Mundt et al. 2002).

  Measure completed at baseline (start of week 1) and week 9.

Secondary Outcomes (10)

• Time Use Survey - Structured Hours (TUS-SH)

  Measure completed in weeks 1, 5, 9, 13 and 17.

• Patient Health Questionnaire (PHQ-9)

  Measure completed in weeks 1, 5, 9, 13 and 17.

• Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test

  Measure completed in weeks 1, 5, 9, 13 and 17.

• Paired Associates Learning (PAL) / CANTAB Cognitive Test

  Measure completed in weeks 1, 5, 9, 13 and 17.

• Spatial Working Memory (SWM) / CANTAB Cognitive Test

  Measure completed in weeks 1, 5, 9, 13 and 17.

Other Outcomes (5)

• Sleep Condition Indicator (SCI-8)

  Measure completed in weeks 1, 5, 9, 13 and 17.

• Insomnia Severity Index (ISI)

  Measure completed in weeks 1, 9 and 17.

• Pittsburgh Sleep Quality Index (PSQI)

  Measure completed in weeks 1, 9 and 17.

Study Arms (2)

Sleepio Intervention + Treatment As Usual (TAU)

EXPERIMENTAL

Participants will receive the online Sleepio intervention to be completed approximately once per week, at least 6 sessions during the 8-week period, and complete daily sleep diaries. In addition they will continue their treatment as usual (TAU) with the CAMEO Early Intervention in Psychosis CPFT or Early Intervention in Psychosis Services NSFT care team.

Device: Sleepio

Treatment As Usual (TAU) alone

NO INTERVENTION

Participants will continue their treatment as usual (TAU) with their Early Intervention in Psychosis care team. They will however be offered access to the Sleepio intervention during the follow-up period of the study.

Interventions

Sleepio DEVICE

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.

Sleepio Intervention + Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experiencing or having experienced a First Episode of Psychosis (FEP) within the past 5 years.
• Currently participating in CPFT CAMEO EIPS or NSFT EIS and intending to continue TAU with the specified service for at least the next 4 months.
• Mental capacity for consent.
• Currently experiencing threshold level (score ≤ 16 on SCI-8) of disrupted sleep.
• Adults 18 years or older.
• Ability to understand and follow therapeutic instructions necessary for experiment and respond to online questionnaires.
• Illness duration less than or equal to 5 years. Onset of illness was defined as first contact with psychiatric services for psychotic symptoms.
• Access to the internet.

You may not qualify if:

• Too unwell to viably participate in study.
• A diagnosis of drug induced psychosis or bipolar disorder.
• Psychotic disorder due to a medical or physical disease (i.e. considered to have an organic basis).
• Current drug or alcohol dependency.
• Currently taking prescribed sleep medication or intending to do so during study.
• Currently doing night shift work.
• Travel over 2 time zones during or within two weeks prior to assessment period.

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator
• Cambridge Cognition Ltd: collaborator
• Big Health Inc.: collaborator

Study Sites (1)

Cameo Early Intervention

Cambridge, Cambridgeshire, CB4 1PX, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter B Jones, PhD MD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry / Deputy Head of Clinical School

Model Details: This is a randomised parallel study design, with five points of measurements. Participants will receive either the Sleepio online intervention + treatment as usual (TAU) or TAU alone over an 8-week period. A follow-up period will be conducted for an additional 8 weeks. The original TAU group will be offered the intervention during this period.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 27, 2019
• Study Start: October 30, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)