Insomnia and symptoms of mental health difficulties (anxiety and depression) Mental and Behavioural Disorders
Conditions
Interventions
This study will compare two behavioural sleep interventions (sleep improvement programmes) to understand which is more effective at modifying EEG delta power during NREM sleep. Following baseline asse
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 26/02/2026: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged between 18 and 40 years 3. Participant is able to follow study procedures as laid out in the participant information sheet 4. Sleep efficiency <85% (Pittsburgh Sleep Quality Index [PSQI] items) 5. Screening positive for depressive symptoms on the Patient Health Questionnaire (PHQ-9 [=10]) and/or anxiety symptoms on the Generalised Anxiety Disorder assessment (GAD-7 [=10]] 6. Screen positive for insomnia symptoms on the Sleep Condition Indicator, and meet criteria for insomnia disorder: 6.1. Sleep latency or WASO: =30 mins (Q1 or Q2 =2) 6.2. Frequency of disturbance: =3 nights a week (Q3 =2) 6.3. Sleep quality: average, poor, or very poor (Q4 =2) 6.4. Daytime functioning: Somewhat, much or very much impaired (Q5 or Q6 =2) 6.5. Chronicity of problem: =3 months (Q8 =2) 7. Typical sleep period takes place within the hours of 9 pm and 10 am 8. Currently registered with a GP practice 9. Able to read and understand English 10. Living within the Oxford area to facilitate at-home polysomnographic recordings 11. Has access to a computer, tablet or smartphone and an internet connection at home, or elsewhere, for treatment sessions _____ Previous key inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged between 18 and 30 years 3. Participant is able to follow study procedures as laid out in the participant information sheet 4. Sleep efficiency <85% (Pittsburgh Sleep Quality Index [PSQI] items) 5. Screening positive for depressive symptoms on the Patient Health Questionnaire (PHQ-9 [=10]) and/or anxiety symptoms on the Generalised Anxiety Disorder assessment (GAD-7 [=10]] 6. Screen positive for insomnia symptoms on the Sleep Condition Indicator, and meet criteria for insomnia disorder: 6.1. Sleep latency or WASO: =30 mins (Q1 or Q2 =2) 6.2. Frequency of disturbance: =3 nights a week (Q3 =2) 6.3. Sleep quality: average, poor, or very poor (Q4 =2) 6.4. Daytime functioning: Somewhat, much or very much impaired (Q5 or Q6 =2) 6.5. Chronicity of problem: =3 months (Q8 =2) 7. Typical sleep period takes place within the hours of 9 pm and 10 am 8. Currently registered with a GP practice 9. Able to read and understand English 10. Living within the Oxford area to facilitate at-home polysomnographic recordings 11. Has access to a computer, tablet or smartphone and an internet connection at home, or elsewhere, for treatment sessions
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 21/05/2026: 1. Previously received sleep restriction therapy 2. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia 3. Another person in the household already participates in this trial 4. Currently taking part in another clinical trial which could affect outcomes in SPECTRUM 5. Currently or recently (within the last 2 months) received inpatient psychiatric treatment 6. Currently taking hypnotic medication that, in the opinion of the investigator, significantly affects sleep. 7. Pregnant/pregnancy planning in the next 6 months 8. Additional sleep disorder diagnosis (e.g., obstructive sleep apnoea) or positive following screening 9. Alcohol or drug-dependent 10. Epilepsy 11. Diagnosis of schizophrenia-spectrum disorder or bipolar disorder, or screening ‘positive’ for possible bipolar disorder 12. Current suicidal ideation with intent OR attempted suicide within the past 2 months 13. Night, evening, early morning or rotating shift-work, or other uncontrollable sleep disturbances such as caring responsibilities or night feeding 14. Transmeridian travel (>=2 time zones) over the past 1 month or planned in the coming 3 months 15. Contraindication to polysomnography such as extremely irritable or sensitive skin on scalp, or allergies to plaster adhesive 16. Any other reason that the investigator deems the participant to be ineligible Previous key exclusion criteria: 1. Previously received sleep restriction therapy 2. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia 3. Another person in the household already participates in this trial 4. Currently taking part in another clinical trial which could affect outcomes in SPECTRUM 5. Currently or recently (within the last 2 months) received inpatient psychiatric treatment 6. Currently taking hypnotic medication or other psychotropic medication that, in the opinion of the investigator, significantly affects sleep. Participants who take antidepressant medication and have been on a stable dose will be eligible. 7. Pregnant/pregnancy planning in the next 6 months 8. Additional sleep disorder diagnosis (e.g., obstructive sleep apnoea) or positive following screening 9. Alcohol or drug-dependent 10. Epilepsy 11. Diagnosis of schizophrenia-spectrum disorder or bipolar disorder, or screening ‘positive’ for possible bipolar disorder 12. Current suicidal ideation with intent OR attempted suicide within the past 2 months 13. Night, evening, early morning or rotating shift-work, or other uncontrollable sleep disturbances such as caring responsibilities or night feeding 14. Transmeridian travel (>=2 time zones) over the past 1 month or planned in the coming 3 months 15. Contraindication to polysomnography such as extremely irritable or sensitive skin on scalp, or allergies to plaster adhesive 16. Any other reason that the investigator deems the participant to be ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative NREM Delta power measured using polysomnography at 4 weeks and 8 weeks (primary end-point) after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In-laboratory timing of circadian phase from Dim Light Melatonin Onset (DLMO) collected from saliva at 8 weeks post-randomisation 2. In-laboratory measure of circadian phase angle from saliva (difference between sleep attempt and DLMO) at 8 weeks post-randomisation 3. Measures of sleep continuity and sleep architecture (EEG variables to include: total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, absolute values of and proportion of total sleep time spent in stage NREM1, NREM2, NREM3, and REM sleep, NREM3 latency, and sleep-state transition probabilities) measured at 4 and 8 weeks post-randomisation 4. Self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 4, 8 and 26 weeks post-randomisation 5. Self-reported anxiety severity measured using the Generalised Anxiety Disorder 7 (GAD-7) at 4, 8 and 26 weeks post-randomisation 6. Self-reported insomnia severity measured using the Insomnia Severity Index (ISI) at 4, 8 and 26 weeks post-randomisation 7. Sleep-related quality of life measured using the Glasgow Sleep Impact Index (GSII) at 4, 8 and 26 weeks post-randomisation 8. Chronotype measured using the reduced morningness-eveningness questionnaire (rMEQ) at 8 weeks post-randomisation 9. Self-reported pre-sleep arousal measured using the pre-sleep arousal scale (PSAS) at 4, 8 and 26 weeks post-randomisation 10. Cortical arousal measured using pre-sleep and NREM beta power (relative and absolute) derived from polysomnography at 4 and 8 weeks post-randomisation 11. Vigilance assessed hourly during DLMO protocol using the psychomotor vigilance test (PVT) at 8 weeks post-randomisation 12. State sleepiness measured hourly with the Karolinska Sleepiness Scale (KSS) at 8 weeks post-randomisation 13. Mediation analysis: Relative NREM delta power (measured with PSG) at week 4 as a mediator of PHQ-9 and GAD-7 at 8 weeks post-randomisation 14. Mediation analysis: Wake-time after sleep onset (measured with PS | — |
Countries
England, United Kingdom
Contacts
Public ContactNicola Barclay
Outcome results
None listed