Supporting employees with insomnia and emotional regulation problems

Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Participants are randomly allocated through blocked randomisation with stratification into the SLEEP intervention or a waitlist control group with a 1:1 allocation ratio. The researchers will stratify across different employer sites in the Midlands to ensure weighting approximate to staff size and representation of the larger population. The SLEEP trial is a hybrid digital intervention of cognitive behaviour therapy for insomnia and emotion regulation for a duration of 6 weeks, that includes self‐guided components on sleep psychoeducation, sleep monitoring, cognitive behavioural therapy, and guided sleep restriction therapy with a trained therapist. Content for the self‐guided intervention will be digitised and presented via an online platform, with each component being tailored to maximise the relevance of the treatment as a workplace intervention and the generalisability of the treatment across industries. The bulk of the treatment content is a self‐paced ‘homework’ that participants complete during the week, and supported by online therapists. The core components of the SLEEP intervention will include: 1. Psychoeducation of sleep science 2. Stimulus control therapy 3. Sleep restriction therapy 4. Cognitive therapy for addressing insomnia‐related cognitions and behaviour 5. Emotion regulation skills training (non‐judgmental awareness, acceptance and tolerance, effective self‐support, analysis and modification, physical activity) 6. Goal‐setting (action planning, goal‐setting) CONDITION: Insomnia, anxiety and depression ; Mental and Behavioural Disorders ; Nonorganic insomnia, Anxiety disorder, unspecified, Depressive episode, unspecified PRIMARY OUTCOME: ; 1. Insomnia measured using the Insomnia Severity Index at baseline, post‐intervention (8 weeks) and follow‐up (12 weeks); 2. Anxiety measured using the General Anxiety Disorder‐7 at baseline, post‐intervention (8 weeks) and follow‐up (12 weeks); 3. Depression measured using the Patient Health Questionnaire‐9 at baseline, post‐intervention (8 weeks) and follow‐up (12 weeks); INCLUSION CRITERIA: 1. Able to give informed consent 2. English‐speaking 3. In employment (including being on furlough) 4. Insomnia Severity Index score: x >8 5. General Anxiety Disorder‐7 score: x >5 or Patient Health Questionnaire‐9 score: x >5 6. =18 years of age SECONDARY OUTCOME: ; 1. Sleep quality parameters measured using Camntech MotionWatch actigraphy trackers at week 1 (pre‐intervention) and week 8 (post‐intervention); 2. Job productivity measured using the Work Productivity and Activity Impairment: General Health v2.0 at baseline, post‐intervention (8 weeks) and follow up (12 weeks); 3. Job satisfaction measured using the Indiana Job Satisfaction Scale at baseline, post‐intervention (8 weeks) and follow up (12 weeks); 4. Well‐being measured using the Warwick‐Edinburgh Mental Health Well‐being Scale at baseline, post‐intervention (8 weeks) and follow up (12 weeks); 5. Quality of life measured using the EuroQOL EQ‐5D‐5L questionnaire at baseline, post‐intervention (8 weeks) and follow up (12 weeks); 6. User experience behaviour of platform usage collected as the number of log‐ins and counts of activities completed on the platform over the 8‐week intervention period. These will be downloaded by the research team directly from the platform at the end of each week.;
Epistemonikos ID: 209f066a3d74b5af3cedc62150841f7484644ca9
First added on: Oct 16, 2021