Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Based on progress achieved so far, the current proposal focuses on further exploring the psychosocial determinants of shift work disorder (SWD) with 120 participants (Phase 1) and testing (Phase 2) with 40 participants an adapted version of BT‐I to this population (20 participants in treatment group, 20 participants in waiting condition (4 weeks) before receiving CBT‐I). The protocol used for Phase 1 is passive, observational and multifactorial. No random distribution is possible for this part of the study since there is no experimental manipulation. The design includes two factors. The first factor is the work schedule, containing two levels, either continuous or fragmented. The second factor is sleep disorder and consists of two levels, either the presence of shift work disorder (SWD) or good sleepers. Thus, a factorial design is developed generating the following four groups: (a) shift workers with a continuous schedule with SDW; (b) shift workers with continuous schedule good sleepers; (c) shift workers with a fragmented schedule with SWD; and (d) shift workers with fragmented schedule good sleepers. Participants who express interest following the publicity of the study are contacted by telephone for a 15‐minute telephone interview to determine eligibility. Thereafter, eligible persons are invited to the sleep laboratory for evaluation in Phase 1. Two individual diagnostic interviews are then conducted by two different investigators: one for sleep disorders' screening and one for psychopathologies screening. The participants also answer a series of online questionnaires on health, depression, anxiety and sleep. The researchers then take participants measurements (weight, height) and check blood pressure while lying and sitting. For two weeks, participants wear an actigraph and fill out an online sleep diary. At the end of these two weeks, a meeting is held with the research coordinator to resume participants sl CONDITION: Shift work disorder ; Mental and Behavioural Disorders SECONDARY OUTCOME: ; 1. Participant's eligibility is assessed with a 15 minutes’ telephone questionnaire at baseline.; 2. Work schedule and the reasons for working at night are measured with a questionnaire called Your Work Schedule at baseline; 3. Presence of current or past psychological disorders are assessed with the MINI (Mini International Neuropsychiatric Interview), a semi‐structured interview conducted at baseline; 4. Presence of sleep disorders, their history, sleep patterns, precipitating and maintenance factors, temporal relationship between the onset of night work and sleep difficulties, information on the schedule and number of working hours are assessed with an adaptation of the Structured Insomnia Interview, a semi‐structured interview conducted at baseline and 2 weeks after treatment; 5. Vital functions and physiological parameters are measured at baseline and after the treatment as follows: participants are weighed and measured to derive the Body Mass Index. Blood pressure and heart rate are recorded while sitting, standing and lying down with a Life Style digital device.; 6. Physiological activation is measured with three different questionnaires at baseline, in the waiting condition 2 weeks before treatment, 2 weeks after treatment and 6 months after treatment:; 6.1. The medical history questionnaire (completed at baseline only) targets medical conditions, current and past medication use, physical activity level, meal times, cigarette and alcohol consumption; 6.2. The Chronotype questionnaire measures whether a person is the morning type (best vigilance in the morning) versus the evening type (best vigilance in the evening); 6.3. The Activation Predisposition Scale measures the intensity of somatic and cognitive activation symptoms.; 7. Cognitive activation is measured with three different questionnaires at baseline, in the waiting condition 2 weeks before treatment, 2 weeks after treatment and 6 months after treatment. The Dysfunctional beliefs and attitudes about sleep questionnaire assesses beliefs and attitudes related to sleep and insomnia (misattribution or amplification of the causes of insomnia, concerns about sleep, unrealistic expectations about sleep, false beliefs about the consequences of insomnia). The Cognitive scale of the Activation Predisposition Scale measures the intensity of cognitive activation symptoms. The Glasgow Content of Thoughts Inventory (GCTI) assessed the frequency of intrusive thoughts at sleep.; 8. Stimulus control (information on sleep pattern) are measured with initial interview (at baseline and 2 weeks after treatment), and with sleep diary and actigraph during 2 weeks at baseline, in the waiting condition 2 weeks before receiving treatment, during the whole treatment (8 to 10 weeks), 2 weeks after treatment and 2 weeks, 6 months follow‐up after the treatment.; 9. Emotions variables are measured with three different questionnaires at baseline, in the waiting condition 2 weeks before treatment, 2 weeks after the treatment and 6 months after treatment:; 9.1. The Beck‐II Depression Inventory assesses the severity of depressive symptoms; 9.2. The situational anxiety and anxiety trait inventory assesses the state of anxiety that refers to situational anxiety and the anxiety trait that considers anxiety as a personality trait; 9.3. The Diagnostic Inventory for Depression (DID) questionnaire assesses the relationship between work schedule and depression symptoms, the severity of depressive symptoms, the psychosocial rupture following the depressive state and subjective quality of life; 10. Sleep facilitators are measured with four different questionnaires at baseline, in the waiting condition 2 weeks before treatment, 2 weeks after treatment and 6 months after treatment:; 10.1. The job satisfaction scale (completed at baseline only) from the Standard Shift‐Work Index assesses the level of job satisfaction; 10.2. The territorial space questionnaire (completed at baseline only) gets information on civic address, the name and address of the workplace and the type of housing; 10.3. The dyadic adjustment scale measures the level of distress and satisfaction of the couple; 10.4. The questionnaire for evaluating healthy lifestyles assesses eating habits, physical activity, alcohol and tobacco consumption, stress management and professional life; INCLUSION CRITERIA: 1. Over 18 years old 2. Working during night shift at least five nights out of 14 days for at least three months in Quebec hospitals and their research centres, health and social services centres, long‐term care residential centres, and residences for the elderly 3. Night work between 24:00 and 8:00 (± 1 hour) PRIMARY OUTCOME: ; 1. The following sleep variables are calculated for each sleep period (main, 24‐hour, naps and night): total wakefulness time (total waking time from bedtime to bedtime), sleep latency, total sleep time (TST; bedtime to bedtime sleep time) and sleep efficiency (ratio of TST to total bedtime) with the actigraph (Respironic). The actigraph is worn like a watch and records the movement continuously using a microprocessor. Actigraph is worn for 2 weeks at baseline, in the waiting condition 2 weeks before receiving treatment, during the whole treatment (8 to 10 weeks), 2 weeks after treatment and 2 weeks, 6 months follow‐up after the treatment.; 2. The following sleep variables are calculated for each sleep period (main, 24‐hour, naps and night): total wakefulness time (total waking time from bedtime to bedtime), sleep latency, total sleep time (TST; bedtime to bedtime sleep time) and sleep efficiency (ratio of TST to total bedtime) with an online sleep diary. The sleepiness questions contained in the sleep diary are taken from the Stanford Sleepiness Scale. When the participant wakes up, he or she answers online questions about his or her sleep. Sleep diary is completed during 2 weeks at baseline, in the waiting condition 2 weeks before receiving treatment, during the whole treatment (8 to 10 weeks length), 2 weeks after treatment and during 2 weeks, 6 months follow‐up after treatment.; 3. Sleep quality, latency, duration and effectiveness as well as diurnal consequences are measured with Pittsburgh Sleep Quality Index (IQSP). IQSP is completed online at baseline, in the waiting condition 2 weeks before receiving treatment, 2 weeks after treatment and 6 months follow‐up after treatment.; 4. The degree of sleepiness is assessed by the Epworth's Sleepiness Scale completed online at baseline, in the waiting condition 2 weeks before receiving treatment, 2 weeks after treatment and 6 months follow‐up after treatment.; 5. The severity of insomnia is assessed by Insomnia Severity Index ‐ day/night is completed online at baseline, in the waiting condition 2 weeks before receiving treatment, 2 weeks after treatment and 6 months follow‐up after treatment.;
Epistemonikos ID: a92b36dc0442e0762562ef2df027908db01a9330
First added on: Aug 24, 2024