Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2021
INTERVENTION: 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 be conducted by the ePRO system with stratification according to sex (male, female), age (25‐44, 45‐65), depression severity (PHQ‐9 scores: =15, =16) and insomnia severity (ISI scores =19, =20). dCBT‐I will be delivered using the Sleepio® programme (www.sleepio.com and associated Sleepio® app). Sleep hygiene education (SHE) will be provided to those in the control group as a minimal treatment control and delivered via a dedicated webpage. Participants will be assessed at baseline and 5 and 10 weeks post‐randomisation. The primary outcome will be assessed using the Facial Expression Recognition Task (FERT). Faces with seven different expressions (happiness, fear, anger, disgust, sadness, surprise, neutral) are displayed on a screen and participants are required to indicate the expression on the face by selecting a corresponding button. The task takes approximately 15‐20 min to complete and assesses the following dependent variables: Emotion Accuracy, Emotion Misclassifications, and Emotion Reaction time. Emotion Accuracy for sad and happy faces is the primary variable of interest, but accuracy, misclassification, and reaction times will be reported for all expressions. CONDITION: Investigating emotional processing in patients with insomnia co‐occurring with low mood. ; Mental and Behavioural Disorders ; Insomnia co‐occurring with low mood PRIMARY OUTCOME: 1. Emotion accuracy, emotion misclassifications, and emotion reaction time measured using the Facial Expression Recognition Task (FERT) at baseline, 5 and 10 weeks SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 60382d404e0b61640e54b01a56863156492e441a
First added on: Aug 25, 2024