Insomnia Mental and Behavioural Disorders Insomnia and depressive disorder
Conditions
Interventions
This study will use stratified randomisation with an allocation ratio of 1:1 according to gender (Male, Female), age (25-44, 45-65) depression (PHQ-9 Scores: =19 : =20) and insomnia (ISI scores =19 :
Sponsors
University of Oxford
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 25-65 2. A positive screen for probable DSM-5 insomnia disorder using items from the Sleep Condition Indicator (SCI): 2.1. Scoring =2 on item 1 (sleep latency) or item 2 (wakefulness during the night) 2.2. Scoring =2 on item 3 (frequency of disturbance) 2.3. Scoring =1 on item 4 (sleep quality) 2.4. Scoring =2 on daytime functioning items 5 or 6 2.5. Scoring =2 on item 8 (chronicity of problem)) 3. Endorsement of depressive symptoms in the probable "caseness" range (PHQ score = 10) 4. Access to a laptop or desktop computer and reliable internet access either at home or work 5. Able to read and understand English 6. Currently living in the UK
Exclusion criteria
Exclusion criteria: 1. Engaged in psychotherapy for insomnia or depression 2. Previous participation in online sleep treatments 3. Hypnotic, psychotropic or antiepileptic medications 4. Psychiatric comorbidities: 4.1. Psychosis 4.2. Bipolar disorder 5. Diagnosis of epilepsy or other neurological disorders 6. Diagnosis of mild cognitive impairment of dementia 7. Symptoms of a probable additional sleep disorder (e.g. possible obstructive sleep apnea, restless legs syndrome) 8. Serious physical health concerns necessitating surgery or with a survival prognosis of < 6 months 9. Habitual night shift, evening, or rotating shift-workers 10. Suicidal ideation with intent, history of recent suicide attempt (< 2 months) 11. Psychiatric hospital admission in the past month, or crisis team support within the past month 12. Alcohol misuses and dependency or recreational/illicit drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity assessed using the 9 item Patient Health Questionnaire (PHQ-9) after 10 weeks. This test will be completed online. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following tests will be completed online: 1. Self-reported emotion regulation deficits, assessed using the Difficulty with Emotion Regulation Scale after 0 weeks, 5 weeks, 10 weeks and 16 weeks 2. Worry, assessed using the Penn State Worry Questionnaire after 0 weeks, 5 weeks, 10 weeks and 16 weeks 3. Rumination assessed using the Ruminative Response Scale after 0 weeks, 5 weeks, 10 weeks and 16 weeks 4. Perseverative thinking assessed using the Perseverative Thinking Questionnaire at 0 weeks, 5 weeks, 10 weeks and 16 weeks. 5. Mediation effect of emotion regulation (DERS, PSWQ, RRS & PTQ scores) variables (dCBT-i over SHE) at week 5 on depressive symptoms (PHQ-9) at week 10 6. Objective biases in negative emotional processing assessed using the Facial Expression Recognition Task at 0 weeks, 5 weeks, 10 weeks, 16 weeks: 6.1. Accuracy and reaction times in response to sad facial expressions 6.2. Accuracy and reaction times in response to happy facial expressions 7. Mediation effect of emotion processing variables (FERT: Changes in recognition accuracy for happy and sad facial expressions) at week 5 on depressive symptoms (PHQ-9) at week 10. 8. Digit Symbol Substitution Task (DSST) performance (number of correctly matched digit-symbol pairs in 90 seconds) at 0 weeks, 5 weeks, 10 weeks and 16 weeks. 9. Insomnia Severity Index (ISI Scores) at 0 weeks, 5 weeks, 10 weeks and 16 weeks. 10. Total time in bed, sleep-onset latency, total sleep time, and sleep efficiency, assessed using Pittsburgh Sleep Quality Index items 1-4 (PSQI) at 0 weeks, 5 weeks, 10 weeks and 16 weeks. 11. MEQ Scores a 0 weeks, 5 weeks, 10 weeks and 16 weeks 12. Anxiety Severity (GAD-7 Scores) at 0 weeks, 5 weeks, 10 weeks and 16 weeks. 13. Mood instability at 0 | — |
Countries
United Kingdom
Outcome results
None listed