Sleep difficulties in patients at ultra-high risk of psychosis and patients diagnosed with non-affective psychosis Mental and Behavioural Disorders
Conditions
Interventions
A multi-centre two-arm randomised controlled trial testing the addition of the sleep therapy to treatment as usual (TAU) against TAU. There will be two cohorts within the trial, with 554 patients at u
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 14 years or above 2. Patient of mental health services (at the time of referral to the trial), or for young people at UHR seeking help 3. Have a clinical diagnosis of schizophrenia spectrum psychosis (i.e. non-affective psychosis) (ICD-10 codes F20–29) or meet diagnostic criteria for ultra-high risk of psychosis on the Comprehensive Assessment of At-Risk-Mental-States (CAARMS) 4. Experiencing current sleep problems (score > 14 on the Insomnia Severity Index) and would like help to improve sleep 5. Willing and able to give informed consent (or assent with parent/guardian consent for participants aged 14 to 15 years) for participation in the trial
Exclusion criteria
Exclusion criteria: 1. Likely primary diagnosis of sleep apnoea (using the STOP-BANG screen [Chung et al, 2016]) 2. A primary diagnosis of another mental health condition (e.g. substance use disorder) that would be the first clinical priority to treat 3. In forensic settings or Psychiatric Intensive Care Unit (PICU) 4. Command of spoken English inadequate for engaging in the trial 5. Current receipt of significant other psychological therapy or significant change in medication or in another intervention study 6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. Reason for exclusion will be recorded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep is measured using the Insomnia Severity Index at 0, 12 (primary end point), 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 0, 12 and 24 weeks: 1. Psychiatric symptoms (mood, psychotic experiences) and cognitive functioning measured using PHQ-9, R-GPTS Part B, a composite MATRICS score (mean T-score of administered tests) 2. Sleep assessed using Consensus Sleep Diary 3. Cognitive functioning measured using Bell Lysaker Emotion Recognition Task (BLERT) (emotion recognition) 4. Subjective measures of cognitive abilities and functioning: the self-report Scale to Investigate Cognition in Schizophrenia (SSTICS-Brief) 5. Functioning measured using the Time Use Survey, capturing time spent in structured activity including work, education, housework, and leisure, Work and Social Adjustment Scale, actigraphy to capture physical movement 6. Psychiatric symptoms: 6.1. Anxiety measured using GAD-7 6.2. Suicidal ideation measured using the Beck Scale for Suicide Ideation (BSS-5) 6.3. Hallucinations measured using Cardiff Anomalous Perceptions Scale – hallucination items 6.4. Negative symptoms measured using Self-assessment of Negative Symptoms (SNS) 6.5. Comprehensive Assessment of At-Risk-Mental-States-23 (CAARMS) (in UHR group only) 7. Quality of life measured using EQ-5D-5L, ReQol, Warwick-Edinburgh Mental Well-being Scale | — |
Countries
England, United Kingdom
Outcome results
None listed