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Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

ABSTRACT: Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016-2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic. Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition. Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic. NCT02988375.

SUBMITTER: Cheng P

PROVIDER: S-EPMC7798633 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

Cheng Philip P Casement Melynda D MD Kalmbach David A DA Castelan Andrea Cuamatzi AC Drake Christopher L CL

Sleep 20210401 4

<h4>Study objectives</h4>Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic.<h4>Methods</h4>COVID impact, insomnia, general- and COVID-related ...[more]

PMID: 33249492

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Project description:ImportanceAlthough digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.ObjectiveTo evaluate the clinical effectiveness, engagement, durability, and adaptability of dCBT-I.Design, setting, and participantsThis retrospective cohort study was conducted using longitudinal data collected via a mobile app named Good Sleep 365 between November 14, 2018, and February 28, 2022. Three therapeutic modes (ie, dCBT-I, medication, and their combination) were compared at month 1, month 3, and month 6 (primary). Inverse probability of treatment weighting (IPTW) using propensity scores was applied to enable homogeneous comparisons between the 3 groups.ExposuresTreatment with dCBT-I, medication therapy, or combination therapy according to prescriptions.Main outcomes and measuresThe Pittsburgh Sleep Quality Index (PSQI) score and its essential subitems were used as the primary outcomes. Effectiveness on comorbid somnolence, anxiety, depression, and somatic symptoms were used as secondary outcomes. Cohen d effect size, P value, and standardized mean difference (SMD) were used to measure differences in treatment outcomes. Changes in outcomes and response rates (≥3 points change in PSQI score) were also reported.ResultsA total of 4052 patients (mean [SD] age, 44.29 [12.01] years; 3028 [74.7%] female participants) were selected for dCBT-I (n = 418), medication (n = 862), and their combination (n = 2772). Compared with the change in PSQI score at 6 months for participants receiving medication alone (from a mean [SD] of 12.85 [3.49] to 8.92 [4.03]), both dCBT-I (from a mean [SD] of 13.51 [3.03] to 7.15 [3.25]; Cohen d, -0.50; 95% CI, -0.62 to -0.38; P < .001; SMD = 0.484) and combination therapy (from a mean [SD] of 12.92 [3.49] to 6.98 [3.43]; Cohen d, 0.50; 95% CI, 0.42 to 0.58; P < .001; SMD = 0.518) were associated with significant reductions; dCBT-I had a comparable effect as combination therapy (Cohen d, 0.05; 95% CI, -0.05 to 0.15; P = .66; SMD = 0.05), but showed unstable durability. Outcomes of dCBT-I improved steadily and rapidly during the first 3 months, and then fluctuated. The response rates with dCBT-I and combination therapy were higher than with medication. Changes in secondary outcomes indicated statistically significant benefits from dCBT-I and combination therapy. The results of subgroup analysis were consistent with the main findings, demonstrating the superiority of dCBT-I vs medication therapy in various subpopulations.Conclusions and relevanceIn this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits for insomnia. Future studies are needed to analyze its clinical effectiveness and reliability in distinct subpopulations.

Project description:Abstract Introduction Rates of sleep disturbance and sleep medication use have increased during the COVID-19 pandemic, at a time when face-to-face delivery of behavioral insomnia treatments is severely limited. To support research during the pandemic, the FDA released guidelines promoting the use of “alternative methods” to conduct trials in a virtual or decentralized manner. Currently, few data exist regarding the impact of virtual trial enrollment during a pandemic. This abstract presents data from a decentralized, open-label, single-arm real-world clinical trial of the Somryst prescription digital therapeutic for insomnia, which provides insight on who seeks care for insomnia using virtual research methods. Methods In alignment with FDA guidance, the DREAM trial began enrolling patients in March, 2020 with an expected final sample size of 350 adults (Clinical Trial # NCT04325464). This abstract presents data from participants seeking enrollment into the trial via an online screening. Demographic and sleep variables were collected to confirm eligibility. Results Of 1,063 respondents, the majority were female (62%) and the most common age brackets were ages 30–39 (22%); 40–49 (20%); and 50–59 (20%). Most respondents (63.8%) did not report being under the care of a healthcare provider for their insomnia. Respondents reported sleep problems for an average of 12.9 years; sleep problems 5 nights/week; and sleeping an average of 5.4 hours/night. Geographic diversity was high with respondents from 45 states and Washington DC. Of those passing initial screening (N=270), 5.5% reported having another diagnosed sleep disorder, 14.4% reported a comorbid psychological condition, 58.9% reported taking a medication for insomnia, and 30.7% reported taking a medication for depression. Using the Insomnia Severity Index, 16.7% had subthreshold/mild insomnia (score 8–14), 60.0% had moderate insomnia (score 15–21), and 23.7% had severe insomnia (score > 21). Conclusion Respondents to this decentralized trial reported moderate-severe, long-lasting insomnia with high rates of medication use for sleep and depression. Results demonstrate that virtual trials can quickly draw a highly geographically diverse research population, overcoming logistical challenges inherent in a pandemic and resulting in recruiting appropriate, but more geographically diverse, samples than those typically observed in randomized trials of cognitive behavioral therapy for insomnia (CBT-I). Support (if any):

Project description:BACKGROUND:Insomnia in adolescents is common, persistent, and associated with poor mental health including anxiety and depression. Insomnia in adolescents attending child mental health services is seldom directly treated, and the effects of digital cognitive behavioral therapy (CBT) for insomnia (CBTi) on the mental health of adolescents with significant mental health problems are unknown. OBJECTIVE:This open study aimed to assess the feasibility of adding supported Web-based CBT for insomnia to the usual care of young people aged 14 to 17 years attending specialist child and adolescent mental health services (CAMHS). METHODS:A total of 39 adolescents with insomnia aged 14 to 17 years attending specialist CAMHS were assessed and offered digital CBTi. The digital intervention was Sleepio, an evidence-based, self-directed, fully automated CBTi that has proven effective in multiple randomized controlled trials with adults. Self-report assessments of sleep (Sleep Condition Indicator [SCI], Insomnia Severity Scale, and Web- or app-based sleep diaries), anxiety (Revised Child Anxiety and Depression Scale [RCADS]), and depression (Mood and Feelings Questionnaire [MFQ]) were completed at baseline and post intervention. Postuse interviews assessed satisfaction with digital CBTi. RESULTS:Average baseline sleep efficiency was very poor (53%), with participants spending an average of 9.6 hours in bed but only 5.1 hours asleep. All participants scored less than 17 on the SCI, with 92% (36/39) participants scoring 15 or greater on the Insomnia Severity Scale, suggesting clinical insomnia. Of the 39 participants, 36 (92%) scored 27 or greater on the MFQ for major depression and 20 (51%) had clinically elevated symptoms of anxiety. The majority of participants (38/49, 78%) were not having any treatment for their insomnia, with the remaining 25% (12/49) receiving medication. Sleepio was acceptable, with 77% (30/39) of the participants activating their account and 54% (21/39) completing the program. Satisfaction was high, with 84% (16/19) of the participants finding Sleepio helpful, 95% (18/19) indicating that they would recommend it to a friend, and 37% (7/19) expressing a definite preference for a digital intervention. Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety (RCADS: P=.005). CONCLUSIONS:Our study has a number of methodological limitations, particularly the small sample size, absence of a comparison group and no follow-up assessment. Nonetheless, our findings are encouraging and suggest that digital CBTi for young people with mental health problems might offer an acceptable and an effective way to improve both sleep and mental health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/11324.

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Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

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Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

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