Mental health Mental and Behavioural Disorders
Conditions
Interventions
On completion of baseline assessments participants will be randomised using the sortition system to receive either Sleep Restriction Therapy (SRT) + Treatment As Usual (TAU) or TAU alone. SRT will inv
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial. 2. Aged 18 years or above. 3. Screen positive for depressive symptoms on the PHQ-9 (> = 10) and meet criteria for Major Depressive Disorder, assessed via the Structured Clinical Interview for DSM-5 (SCID-5) 4. Screen positive for insomnia symptoms on the sleep condition indicator and meet criteria for Insomnia Disorder 5. Self-reported sleep efficiency < 85% over the past month, assessed via the Pittsburgh Sleep Quality Index (PSQI) 6. Able to attend appointments for assessments and treatment and adhere to study procedures 7. The participant’s GP surgery is participating in the trial
Exclusion criteria
Exclusion criteria: 1. Female participant who is pregnant or planning pregnancy during the trial 2. Additional sleep disorder diagnosis OR “positive” on screening. 3. Dementia or Mild Cognitive Impairment (MCI) 4. Alcohol or substance-use dependent 5. Epilepsy 6. Psychosis (schizophrenia, bipolar disorder) 7. Currently or recently received in-patient psychiatric treatment within the past 2 months 8. Current suicidal ideation with intent OR attempted suicide within the past 2 months 9. Currently receiving cancer treatment OR planned major surgery during the treatment phase 10. Night, evening, early morning or rotating shift-work 11. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia 12. Previously received sleep restriction therapy from a health professional 13. Life expectancy of < 1 year 14. Another person in the household already participates in this trial 15. Currently taking part in another clinical trial which could affect outcomes in RESTED 16. Recruiting clinician deems not suitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 26 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 4 and 8 weeks post-randomisation 2. Self-reported insomnia severity measured using the Insomnia Severity Index (ISI) at 4, 8 and 26 weeks post-randomisation 3. Mediation analysis: Self-reported insomnia severity (ISI) at week 4 as a mediator of PHQ-9 at 26 weeks post-randomisation 4. Sleep onset latency (SOL), Wake After Sleep Onset (WASO), Sleep Efficiency (SE), Total Sleep Time (TST), Relative Amplitude (RA) and Interdaily Stability (IS) measured using actigraphy (measured over 1 week) at post-treatment (8 weeks) and follow-up (26-weeks) 5. Emotional processing bias measured using the Oxford Emotional Test Battery: Facial Expression Recognition Task (FERT, outcomes: accuracy for sad and happy facial expressions), Emotional Categorisation Task (ECAT, outcomes: reaction time for correct positive and negative words) and Emotional Recall Task (EREC, outcomes: number of positive and negative self-referent words correctly recalled) at 8 and 26 weeks post-randomisation. 6. Positive and negative affect measured using the Positive and Negative Affect Schedule (PANAS) at 8 and 26 weeks post-randomisation 7. Repetitive negative thinking measured using the Perseverative Thinking Questionnaire (PTQ) at 8 and 26 weeks post-randomisation 8. Behavioural activation measured using the Behavioural Activation for Depression Scale (BADS-SF) at 4, 8 and 26 weeks post-randomisation 9. Mediation analysis: insomnia at mid-treatment (week 4) increasing behavioural activation (BADS-SF) at week 8 as a mediator of the treatment effect on depression at week 26 10. Self-reported sleep and daily activation (over 1 week) measured using the Consensus Sleep Diary (CSD) at 8 and 26 weeks post-randomisation 11. Psychological well-being measured using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at 8 and 26 weeks post-randomisation 12. Cognitive complaints measured using the British Columbia Cogniti | — |
Countries
United Kingdom
Contacts
Public ContactCharles Vicary
Outcome results
None listed