Can treating sleep problems improve depression? The RESTED Trial

Not Applicable

• Conditions: Mental health; Mental and Behavioural Disorders

• Registration Number: ISRCTN73764282
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Last Update Posted: 2 September 2024
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 26 weeks post-randomisation