Young people (14-25 years) attending NHS mental health services with sleep problems who are at ultra-high-risk of psychosis Mental and Behavioural Disorders Nonorganic sleep disorders
Conditions
Interventions
Participants are randomised (1:1) to the sleep therapy (SleepWell) added to treatment as usual or treatment as usual.
Participants will be randomised once they have completed the baseline assessmen
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 14-25 years 2. Patient of mental health services (at the time of referral to the study) 3. Meet diagnostic criteria for ultra-high-risk of psychosis on the Comprehensive Assessment of At-Risk-Mental States 4. Experiencing current sleep problems (defined as a score >15 on the Insomnia Severity Index) 5. Would like help to improve sleep 6. Participant is willing and able to give informed consent (or assent with parent/guardian consent for participants aged 14-15 years) for participation in the trial
Exclusion criteria
Exclusion criteria: 1. Diagnosis of a primary severe mental health problem (including psychosis, bipolar disorder, personality disorder) 2. A primary diagnosis of alcohol/substance dependency, organic syndrome or learning disability 3. Likely primary diagnosis of sleep apnoea (established using the STOP-BANG screen) 4. Current engagement in any other individual psychological therapy A participant may also not enter the trial if there is another factor (for example, current active suicidal plans, high risk for severe course of COVID-19), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures relate to the feasibility and acceptability of the trial procedures and intervention. The primary clinical outcome is insomnia measured on the Insomnia Severity Index (ISI) at baseline, 3 months, and 9 months. Feasibility markers measured at baseline, 3 months and 9 months: 1. Recruitment and retention: number of patients identified, recruited, declined and retained 2. Referral procedure: number of referrals made per site, and per service type, per month 3. Service provision and comparator: level and type of service use as measured on the Client Service Receipt Inventory (CSRI) 4. Data collection methodology: completion rate of each assessment measure, including wearable-teach devices, and time taken to complete each assessment 5. Acceptability of the intervention: location and attendance at treatment sessions; content covered in treatment sessions; feedback from qualitative interviews; treatment acceptability score (AARP) 6. Health economic data collection: service use data completeness, and time taken to collect service use data | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months and 9 months: 1. Sleep disturbance measured using ISI; SLEEP-50 CRD subscale; sleep diary; actigraphy; fatigue scale 2. Attenuated psychotic experiences measured using CAARMS; SPEQ-H; R-GPTS; CEFSA 3. Psychiatric symptoms measured using DASS-21; CSSRS; DWQ; BCSS 4. Activity and social functioning measured using time budget; WASA; SROBAT; actigraphy 5. Physical health measured using BMI; step-count; BESAA; PHQ15; MAP 6. Quality of life measured using QPR; ReQoL; EQ5D 7. Service use measured using CSRI and medication 8. Participant ranking of clinical outcome variables | — |
Countries
England, United Kingdom
Outcome results
None listed