Health professional Administered Brief Insomnia Therapy (HABIT) trial

INTERVENTION: Participants will be randomised (1:1) to one of the two intervention groups to receive either SRT+SH or SH, using a validated web‐based randomisation programme (Sortition), with a non‐deterministic minimisation algorithm to ensure site, use of prescribed sleep promoting medication (yes/no), age (18‐65 yrs vs. > 65yrs), sex, baseline insomnia severity (ISI score <22 vs. 22‐28) and depression symptom severity (PHQ‐9 score <10 vs. 10‐27) are balanced across the two groups. CONDITION: Specialty: Primary Care, Primary sub‐specialty: Neurological disorders; UKCRC code/ Disease: Insomnia disorders ; Mental and Behavioural Disorders PRIMARY OUTCOME: Self‐rated insomnia severity using the insomnia severity index (ISI) questionnaire collected at baseline, 3, 6 and 12 months post randomization. Primary outcome is at 6 months. INCLUSION CRITERIA: 1. Participant is willing and able to give informed consent for participation in the study 2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM‐5 (American Psychiatric Association) on structured checklist review 3. Sleep efficiency < 85% over the past month 4. Age =18 years 5. Able to attend appointments during baseline and 4‐week intervention (both face‐to‐face at the practice and over the phone) and adhere to study procedures SECONDARY OUTCOME: 1. To compare the effect of SRT+SH versus SH on insomnia severity using self‐rated health‐related quality of life (HRQoL) measured using the SF‐36 questionnaire (Total Score, Mental component summary [MCS] score and Physical component summary [PCS] score) at baseline, 3, 6 and 12 months post‐randomisation.; 2. Subjective sleep recorded over 7 nights using the consensus sleep diary (CSD); (sleep‐onset latency [SOL]; wake‐time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]) at baseline, 6 and 12 months post‐randomisation.; 3. Actigraphy‐recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post‐randomisation.; 4. Self‐rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post‐randomisation. ; 5. Self‐rated depressive symptoms severity using the Patient Health Questionnaire (PHQ‐9) at baseline, 3, 6 and 12 months post‐randomisation.; 6. Self‐rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post‐randomisation.; 7. Use of prescribed hypnotics (quantified from 7‐day diary) at baseline, 6 and 12 months post‐randomisation.; 8. Use of other prescribed sleep‐promoting medications (e.g., sedative antidepressants, anti‐histamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post‐randomisation.; 9. Incremental cost‐effectiveness from both NHS and societal perspectives measured using trial records (time and number of nurse‐led appointments), practice records (medications; baseline and 12 months only), Client Service Receipt Inventory (self‐reported service use, medications), Insomnia Severity Index, WPAI, EQ‐5D‐3L (QALY) at baseline, 3, 6 and 12 months post‐randomisation.; 10. Intervention delivery, fidelity and acceptability assessed using semi‐structured interviews with 1) trial participants; 2) nurses 3) GPs and 4) practice managers; number of appointments attended/received by participants; fidelity appraisal of recorded consultations; and adherence to prescribed sleep window (from sleep diary), throughout the trial.; 11. Adverse events between the groups assessed using questionnaire at baseline, 3, 6, and 12 months.