Investigating emotional processing in patients with insomnia co-occurring with low mood. Mental and Behavioural Disorders Insomnia co-occurring with low mood
Conditions
Interventions
This study will use stratified randomisation with an allocation ratio of 1:1 to either digital cognitive behavioural therapy for insomnia (dCBT-I) or Sleep Hygiene Education (SHE). Randomisation will
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Positive screen for probable DSM-5 insomnia disorder using the following items from the Sleep Condition Indicator (SCI): 1.1. Scoring =2 on item 1 (sleep latency) or item 2 (wakefulness during the night) 1.2. Scoring =2 on item 3 (frequency of disturbance) 1.3. Scoring =1 on item 4 (sleep quality) 1.4. Scoring =2 on daytime functioning items 5 or 6 1.5. Scoring =2 on item 8 (chronicity of problem) 2. Endorsement of depressive symptoms in the probable “caseness” range (PHQ score =10) 3. Aged 25-65 years 4. Access to a laptop or desktop computer and a phone and reliable internet access either at home or work 5. Being 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 (or face to face) sleep treatments 3. Hypnotic, psychotropic, or antiepileptic medications 4. Psychiatric comorbidities of psychosis or bipolar disorder 5. Diagnosis of epilepsy or other neurological disorder 6. Diagnoses of mild cognitive impairment or 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 1 “yes” on C-SSRS suicide item 2), history of recent suicide attempt (<12 months) 11. Psychiatric hospital admission in the past year, or crisis team support within the past year 12. Alcohol misuse & dependency or recreational/illicit drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Emotion accuracy, emotion misclassifications, and emotion reaction time measured using the Facial Expression Recognition Task (FERT) at baseline, 5 and 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported emotion regulation measured using the Difficulties in Emotion Regulation Scale (DERS), the Penn State Worry Questionnaire (PSWQ), and the Perseverative Thinking Questionnaire (PTQ) at baseline, 5 and 10 weeks 2. Mood instability measured using one item (self-rated) from the Structured Clinical Interview for DSM-IV at baseline, 5 and 10 weeks 3. Insomnia symptoms measured using the Insomnia Severity Index (ISI) and supplemented with four items from the Pittsburgh Sleep Quality Index (PSQI) at baseline, 5 and 10 weeks 4. Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 5 and 10 weeks 5. Chronotype measured using the Munich Chronotype Questionnaire (MCTQ) at baseline, 5 and 10 weeks 6 Positive and Negative Affect measured using the Positive and Negative Affect Schedule – Short Form (PANAS-SF) at baseline, 5 and 10 weeks 7. Emotional bias for words measured using the Emotional Categorisation Task (ECAT) at baseline, 5 and 10 weeks 8. Emotional memory measured using the Emotion Recognition Memory Task (EMEM) at baseline, 5 and 10 weeks 9. Engagement with mental health services and sleep medication measured using the following three questions: " Since your last study assessment, have you taken any medication for your sleep problems?" (Yes/No), "Since your last study assessment, have you undergone any additional psychological therapies for your sleep problems?" (Yes/No), and "Since your last study assessment, have you received treatment for your mental health, for example, medication, counselling, or other psychological therapies?" (Yes: Psychological Therapies/Yes: Medication/Yes: Counselling/Yes: A combination of the above/No) at baseline, 5 and 10 weeks 10. Device use measured using Device Monitoring Questions (as control variables) at 5 and 10 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactSandra Tamm
Outcome results
None listed