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CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180709
Recruitment Status : Suspended (All non-COVID-19 NIHR research is suspended due to social distancing measures.)
First Posted : November 27, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborators:
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge Cognition Ltd
Big Health
Information provided by (Responsible Party):
Peter Jones, University of Cambridge

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. Finally, improved sleep may reduce systemic inflammation that may itself mediate the links between cognition and daily function. This research of inflammatory markers (cytokines) correlated with sleep and cognition will provide pilot data for future immunopsychiatry research.

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). Cameo is a service for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk). 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 CAMEO team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.


Condition or disease Intervention/treatment Phase
Psychotic Disorders Psychosis Sleep Device: Sleepio Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
Estimated Study Start Date : June 28, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sleepio Intervention + Treatment As Usual (TAU)
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 care team.
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.

No Intervention: Treatment As Usual (TAU) alone
Participants will continue their treatment as usual (TAU) with the CAMEO Early Intervention in Psychosis care team. They will however be offered access to the Sleepio intervention during the follow-up period of the study.



Primary Outcome Measures :
  1. Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study [ Time Frame: Measure completed at baseline (start of week 1) and week 9. ]
    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).


Secondary Outcome Measures :
  1. Time Use Survey - Structured Hours (TUS-SH) [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.

  3. Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    iPad delivered cognitive test of sustained attention.

  4. Paired Associates Learning (PAL) / CANTAB Cognitive Test [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    iPad delivered cognitive test of visual episodic memory.

  5. Spatial Working Memory (SWM) / CANTAB Cognitive Test [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    iPad delivered cognitive test of working memory and strategy.

  6. Emotion Recognition Task (ERT) / CANTAB Cognitive Test [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    iPad delivered cognitive test of emotional recognition.

  7. Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S) [ Time Frame: Measure completed in weeks 1, 9 and 17. ]
    GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).

  8. Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17 [ Time Frame: Measure completed at baseline (start of week 1) and week 17. ]
    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).

  9. Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis [ Time Frame: Measure completed at baseline (start of week 1) and week 5. ]
    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).

  10. Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis [ Time Frame: Measure completed at baseline (start of week 1) and week 13. ]
    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).


Other Outcome Measures:
  1. Sleep Condition Indicator (SCI-8) [ Time Frame: Measure completed in weeks 1, 5, 9, 13 and 17. ]
    SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017).

  2. Insomnia Severity Index (ISI) [ Time Frame: Measure completed in weeks 1, 9 and 17. ]
    ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011).

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measure completed in weeks 1, 9 and 17. ]
    PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003).

  4. Validation of Sleep Diaries by comparison with actigraphy activity data [ Time Frame: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period. ]

    Nightly sleep diaries will be reported online using the Sleepio.com online diary.

    GENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure.

    The actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experiencing or having experienced a First Episode of Psychosis (FEP) within the past 5 years.
  • Currently participating in CAMEO Early Intervention services (North or South) and intending to continue TAU with CAMEO 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.

Exclusion Criteria:

  • 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 shift work.
  • Travel over 2 time zones during or within two weeks prior to assessment period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180709


Locations
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United Kingdom
Cameo Early Intervention
Cambridge, Cambridgeshire, United Kingdom, CB4 1PX
Sponsors and Collaborators
University of Cambridge
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge Cognition Ltd
Big Health
Investigators
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Principal Investigator: Peter B Jones, PhD MD University of Cambridge
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Responsible Party: Peter Jones, Professor of Psychiatry / Deputy Head of Clinical School, University of Cambridge
ClinicalTrials.gov Identifier: NCT04180709    
Other Study ID Numbers: M00915
RNAG-521 ( Other Grant/Funding Number: Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) )
224101 ( Other Identifier: Integrated Research Application System (IRAS) )
19/EE/0352 ( Other Identifier: NHS HRA - Cambridge South Research Ethics Committee )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Jones, University of Cambridge:
Cognition
Social Recovery
Immunopsychiatry
Daily function
Sleep disturbances
Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Psychotic Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders