Table 1.
Objectives | Outcome measures | |
Primary | Assess the feasibility and acceptability of a targeted sleep intervention to prevent psychosis and to establish key parameters for a future randomised controlled trial. | Number of patients identified, recruited, declined and retained. |
Number of referrals made per site, and per service type, per month. | ||
Service use as measured on the CSRI. | ||
Completion rate of each assessment measure, including wearable-technology devices. Time taken to complete each assessment. | ||
Location and attendance at treatment sessions; content covered in treatment sessions; feedback from qualitative interviews; treatment acceptability score (AARP). | ||
Service use data completeness, time taken to collect service use data. | ||
Secondary | Gather data on clinical outcomes to provide a preliminary indication of the clinical effectiveness of a novel sleep intervention (SleepWell) in addition to usual care versus usual care alone in young people with sleep problems who are at ultra-high-risk of psychosis attending NHS mental health services | Sleep disturbance: ISI; Sleep-50 CRD; Sleep diary; Actigraphy; Fatigue. Attenuated psychotic experiences: CAARMS; SPEQ-H; R-GPTS; ČEFSA. Psychiatric symptoms: DASS-21; C-SSRS; DWQ; BCSS. Activity and social functioning: Time budget; WASA; Oxford Agoraphobic Avoidance Scale; actigraphy. Physical health: BMI; step-count; BESAA; PHQ15; MAP. Quality of life: QPR; ReQoL; EQ5D. Service use: CSRI; and medication. Participant ranking of clinical outcome variables. |
Qualitative | To explore the acceptability of study procedures to service users. | Feedback from qualitative interviews. |
AARP, Abbreviated Acceptabliity Rating Profile; BCSS, Brief Core Schema Scale; BESAA, Body Esteem Scale for Adults and Adolescents; CAARMS, Comprehensive Assessment of At-Risk-Mental States; CRD, Circadian Rhythm Disruption; CSRI, Client Service Receipt Inventory; C-SSRS, Columbia Suicide Severity Rating Scale; DASS-21, Depression, Anxiety, and Stress Scale; DWQ, Dunn Worry Questionnaire; ČEFSA, Černis Felt Sense of Anomaly Scale; ISI, Insomnia Severity Index; MAP, Maudsley Addiction Profile; NHS, National Health Service; PHQ15, Patient Health Questionnaire; QPR, Process of Recovery Questionniare; R-GPTS, Revised Green et al Paranoid Thoughts Scale; SPEQ-H, Specific Psychotic Experiences Questionnaire - Hallucinations subscale; WASA, Work and Social Adjustment Scale.