scholarly journals 0470 A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia in Pregnant Women

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A180-A180
Author(s):  
D A Kalmbach ◽  
A Cuamatzi-Castelan ◽  
C V Tonnu ◽  
T Roth ◽  
R Sangha ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Sleep Duration ◽  
Behavioral Therapy ◽  
Depression Scale ◽  
Emotional Dysregulation ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Randomized Controlled

Abstract Introduction Over half of pregnant women experience clinical insomnia, which is linked to perinatal depression and cognitive-emotional dysregulation. Despite high rates of prenatal insomnia and known maternal consequences, efficacious insomnia treatment options for this population are woefully scant. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy digital CBTI via mobile health app in pregnant women with insomnia. Methods Single-site RCT. Ninety-one pregnant women (29.03±4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. Blinded assessments were performed before treatment, after treatment (during pregnancy), and 6 weeks after childbirth. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale’s Cognitive factor (PSAS-C) served as study outcomes. Results From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p<.001) and PSQI (-2.98 points, p<.001) and increases in nightly sleep duration by 32 minutes. Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 minutes per night (p=.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed. Conclusion Digital CBTI improves sleep quality and increases sleep duration during pregnancy and after childbirth. Digitally delivered interventions have potential to improve the health of new and expectant mothers, but CBTI likely needs to be tailored for perinatal patients to optimize outcomes. Support This study was funded by the American Academy of Sleep Medicine (198-FP-18, PI: Kalmbach).

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial

10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

Background Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care. Objective This randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth. Methods This nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale. Results We included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=−1.97, P=.049, Cohen d=0.28, 95% CI –0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03). Conclusions Fear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. Trial Registration ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)

scholarly journals Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna L. MacKinnon ◽  
Joshua W. Madsen ◽  
Ashley Dhillon ◽  
Elizabeth Keys ◽  
Gerald F. Giesbrecht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Sleep Problems ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
The Impact ◽  
In Pregnancy

Abstract Background Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). Methods A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). Discussion CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. Trial registration ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

scholarly journals Anonymous online cognitive behavioral therapy for sleep disorders in shift workers—a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lukas Retzer ◽  
Monika Feil ◽  
Richard Reindl ◽  
Kneginja Richter ◽  
Robert Lehmann ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Intervention Group ◽  
Online Intervention ◽  
Waiting List ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Shift Workers ◽  
Face To Face ◽  
Randomized Controlled

Abstract Background Many shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anonymous online cognitive behavioral therapy for insomnia (CBT-I) program. After successful completion of a feasibility study, we now start this prospective, randomized, controlled superiority trial to compare outcomes of two parallel groups, namely an intervention group and a waiting-list control-group. Additionally, we will compare these outcomes to those of a face-to-face CBT-I outpatient sample. Methods Collaborating companies will offer our anonymous online intervention to their shift-working employees. Company physicians and counseling services will screen those interested for inclusion and exclusion criteria. Participants will receive access to our online service, where they will complete psychometric assessment and receive random assignment to either the intervention group or the waiting-list control group. Participants and providers will be aware of the group assignment. We aim to allocate at least N = 60 participants to the trial. The intervention consists of psychoeducation, sleep restriction, stimulus control, relaxation techniques, and individual feedback delivered via four e-mail contacts. During the intervention, as well as during the waiting period, participants will fill out weekly sleep diaries. Immediately after completion of the program, the post-intervention assessment takes place. Participants in the control group will be able to participate in the program after all study assessments. To recruit an additional sample, collaborating outpatient sleep clinics will provide six sessions of standard face-to-face CBT-I to an ad hoc sample of shift working patients. We expect both the online and the face-to-face CBT-I interventions to have beneficial effects compared to the control group on the following primary outcomes: self-reported symptoms of depression and insomnia, sleep quality, and daytime sleepiness. Conclusions The online intervention allows shift workers to follow a CBT-I program independently of their working schedule and location. Forthcoming results might contribute to further improvement of prevention and therapy of sleep issues in shift workers. Trial registration German Clinical Trials Register DRKS DRKS00017777. Registered on 14 January 2020—retrospectively registered.

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: A Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

BACKGROUND Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth (FOB) should be handled in clinical care. OBJECTIVE This randomized controlled trial (RCT) aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care (SC) on the levels of FOB in a sample of pregnant women reporting FOB. METHODS This nonblinded, multicenter RCT with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders (UP) and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their FOB and find new ways of coping with difficult thoughts and emotions. SC was offered in the three different study regions. The primary outcome was self-assessed levels of FOB, measured using the Fear of Birth Scale (FOBS). RESULTS We included 258 pregnant women reporting clinically significant levels of FOB (guided ICBT group, 127; SC group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of FOB did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of FOB (U=3674.00, z=−1.97, P=.049, Cohen d=0.28, 95% CI –0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of FOB over time was found (P=<.001), along with a significant interaction between time and intervention, showing a larger reduction in FOB in the guided ICBT group over time (F1,192.538=4.96, P=.03). CONCLUSIONS FOB decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. CLINICALTRIAL ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)

scholarly journals A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women

2020 ◽  
Vol 72 ◽  
pp. 82-92 ◽  
Author(s):  
David A. Kalmbach ◽  
Philip Cheng ◽  
Louise M. O'Brien ◽  
Leslie M. Swanson ◽  
Roopina Sangha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled

scholarly journals The Effects of Cognitive Behavioral Therapy on Depression and Anxiety among Patients with Thalassemia: a Randomized Controlled Trial

2018 ◽  
Vol 7 (4) ◽  
pp. 219-224 ◽  
Author(s):  
Fateme Mohamadian ◽  
Maryam Bagheri ◽  
Maryam Sadat Hashemi ◽  
Hossein Komeili Sani
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Post Test ◽  
Experimental Group

Introduction: Thalassemia is a chronic hereditary anemia which can be associated with different psychological, emotional, and behavioral problems such as depression and anxiety. This study aimed to evaluate the effects of cognitive behavioral therapy on depression and anxiety of patients with thalassemia. Methods: This was a randomized controlled trial study. A total of 76 patients were randomly allocated to an experimental (n=38) and a control group (n=38). Patients in the experimental group were provided with cognitive behavioral therapy while their counterparts in the control group received routine care services. Depression and anxiety assessments were performed four weeks before the intervention as well as four and six weeks after that. Between-group and within-group comparisons were performed through the independent-sample t-tests and the paired sample t-test, respectively Results: The post-test mean score of anxiety in the experimental group was significantly lower than that for the control group, while there was no significant difference between the groups regarding the post-test mean score of depression. The mean score of depression in both study groups decreased significantly. The rate of decrease in the experimental group was significantly greater than that in the control group. Conclusion: Cognitive behavioral therapy can be used to prevent or alleviate depression and anxiety among patients.

scholarly journals Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial (Preprint)

2018 ◽  
Author(s):  
Daisuke Sato ◽  
Naoki Yoshinaga ◽  
Eiichi Nagai ◽  
Kazue Nagai ◽  
Eiji Shimizu
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Sleep Onset ◽  
Depression Scale ◽  
Sleep Efficiency ◽  
Cognitive Behavioral ◽  
University Hospital ◽  
Sleep Onset Latency ◽  
Onset Latency ◽  
Randomized Controlled

BACKGROUND In reality, pharmacotherapy still remains the most common treatment for insomnia. OBJECTIVE This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics. METHODS We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up). RESULTS The adjusted mean reduction (−6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study. CONCLUSIONS These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).

scholarly journals Effectiveness of Conventional Cognitive-Behavioral Therapy and Its Computerized Version on Reduction in Pain Intensity, Depression, Anger, and Anxiety in Children with Cancer: A Randomized, Controlled Trial

2020 ◽  
Vol 14 (4) ◽  
Author(s):  
Vajihe Hamedi ◽  
Najmeh Hamid ◽  
Kioumars Beshlideh ◽  
Sayed Ali Marashi ◽  
Seyed Esmaeil Hashemi Sheikh Shabani
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Pain Intensity ◽  
Behavioral Therapy ◽  
Negative Emotions ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Psychological Interventions ◽  
Negative Effects ◽  
Children With Cancer ◽  
Randomized Controlled

Background: Experiencing painful procedures during life is inevitable. Poor pain management is associated with negative effects on the quality of life, remaining for a long time after the experience. Long-term negative effects of pain possess a significant cost burden on society. Nowadays, computers are globally available, and computerized psychological interventions can reduce negative emotions. Objectives: The present study aimed at examining the effectiveness of conventional cognitive-behavioral therapy (CBT) and its computerized version on reduction in pain intensity, depression, anger, and anxiety in children with cancer. Methods: The present randomized, controlled, clinical trial was performed on three groups of conventional CBT, computerized CBT (cCBT), and control. Children with cancer, referring to Shafa Hospital of Ahvaz, Iran, constituted the study samples. A total of 15 children aged 9 - 12 years were assigned to each group by using the lottery method. All three groups received routine medical treatments during the study, but the two intervention groups also received psychological interventions as a complementary treatment. The control group received routine medical treatment and underwent cCBT intervention after the study. The data-i e, pre- and post-tests, were collected by a masters’ student in clinical psychology that was blind to the study objectives. Data were analyzed by MANCOVA, ANOVA, and t-tests of differential scores. Results: The findings of the study indicated that both interventions could reduce negative emotions associated with cancer (i. e, pain, anger, anxiety, and depression) in children compared with the control group (P < 0.0001). In addition, there were no significant differences between the two intervention groups (P < 0.01). It means both interventions were useful to reduce pain and enhance adjustment. Conclusions: The cCBT can be utilized in case of no access to psychologists and psychological services.

scholarly journals SUN-569 The Normalization of Sleep Duratioin as a Factor of Glyhemoglobin Reducing

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Irina Dzherieva ◽  
Natalya Volkova ◽  
Maria Komurdzhyntcs ◽  
Ilia Davidenko ◽  
Lilia Ganenko ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Sleep Apnea ◽  
Cognitive Behavioral Therapy ◽  
Sleep Duration ◽  
Diabetes Mellitus Type 2 ◽  
Behavioral Therapy ◽  
Depression Scale ◽  
Diabetes Mellitus Type ◽  
Cognitive Behavioral

Abstract Sleep deprivation is an important risk factor of the metabolic disorder. According to the systematic review published in the Circulation there are a lot of data from epidemiological, clinical and experimental researches which confirm this fact. The goal of our research was to assess the level of glycohemoglibin after the normalization of sleep duration. 24 patients with diabetes mellitus type2 (19 females and 7 males, average age 58.7 ±1.3 yer) were included in the research. Diabetes mellitus type 2 duration was 9.5 years. Criteria excluded were myocardial infarction, stroke, sleep apnea, oncological diseases and depression. To exclude depression we used the questionnaires: Center for Epidemiological Studies Depression Scale and The Hospital Anxiety And Depression Scale. To exclude sleep apnea we used questionnaire STOP-Bang score. The sleep duration was assessed by the patients self-reports. Glycohemoglibin was determined by Immunoinhibition Method Cobas 6000, Roche Diagnostics. The sleep duration was corrected by cognitive behavioral therapy. For statistic assess of the results we used the method Wilcoxon F. Results: At the beginning of the treatment the level of glyhemoglobin was 7.8% and the sleep duration was 6.4 hours.The included patients were treated by cognitive behavioral therapy for 6 months without changing other kinds of therapy. The sleep duration significantly(P=-0.35) enlarged until 7.5±0.2 hours and the level of glyhemoglobin was lowered by 0.4% significantly (P=0.47). The improving of sleep duration can successfully reduce the level of glyhemoglobin in diabetes mellitus type 2 without any intervention at glycemia and could contribute to the prevention of diabetes complications.

scholarly journals Anonymous Online Cognitive Behavioral Therapy for Sleep Disorders in Shift Workers – A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Lukas Retzer ◽  
Monika Feil ◽  
Richard Reindl ◽  
Kneginja Richter ◽  
Robert Lehmann ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Intervention Group ◽  
Online Intervention ◽  
Waiting List ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Shift Workers ◽  
Face To Face ◽  
Randomized Controlled

Abstract Background: Many shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anonymous online cognitive behavioral therapy for insomnia (CBT-I) program. After successful completion of a feasibility study, we now start this prospective, randomized, controlled superiority trial to compare outcomes of two parallel groups, namely an intervention group and a waiting-list control-group. Additionally, we will compare these outcomes to those of a face-to-face CBT-I outpatient sample.Methods: Collaborating companies will offer our anonymous online intervention to their shift-working employees. Company physicians and counseling services will screen those interested for inclusion and exclusion criteria. Participants will receive access to our online service, where they will complete psychometric assessment and receive random assignment to either the intervention group or the waiting-list control group. Participants and providers will be aware of the group assignment. We aim to allocate at least N = 60 participants to the trial. The intervention consists of psychoeducation, sleep restriction, stimulus control, relaxation techniques, and individual feedback delivered via four e-mail contacts. During the intervention, as well as during the waiting period, participants will fill out weekly sleep diaries. Immediately after completion of the program, the post-intervention assessment takes place. Participants in the control group will be able to participate in the program after all study assessments. To recruit an additional sample, collaborating outpatient sleep clinics will provide six sessions of standard face-to-face CBT-I to an ad-hoc sample of shift working patients. We expect both the online and the face-to-face CBT-I interventions to have beneficial effects compared to the control group on the following primary outcomes: self-reported symptoms of depression and insomnia, sleep quality, and daytime sleepiness. Conclusions: The online intervention allows shift workers to follow a CBT-I program independently of their working schedule and location. Forthcoming results might contribute to further improvement of prevention and therapy of sleep issues in shift workers.

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