Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial.

BACKGROUND: Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. METHODS: A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. DISCUSSION: It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. TRIAL REGISTRATION: ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.

Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial.

BACKGROUND: Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many countries, cultural compatibility. Smartphone-based treatment is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia. METHODS: A parallel-group randomized, waitlist-controlled trial was conducted with 320 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention (week 6) follow-up, and week 12 follow-up. The waitlist group received treatment after the week 6 follow-up. RESULTS: Intention to treat analysis was conducted with multilevel modeling. In all but one model, the interaction between treatment condition and time at week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression [Center for Epidemiologic Studies Depression Scale (CES-D): Cohen's d = 0.86, 95% CI (-10.11 to -5.37)], insomnia [Insomnia Severity Index (ISI): Cohen's d = 1.00, 95% CI (-5.93 to -3.53)], and anxiety [Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A): Cohen's d = 0.83, 95% CI (-3.75 to -1.96)]. They also had better sleep quality [Pittsburgh Sleep Quality Index (PSQI): Cohen's d = 0.91, 95% CI (-3.34 to -1.83)]. No differences across any measures were found at week 12, after the waitlist control group received the treatment. CONCLUSION: proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04228146. Retrospectively registered on 14 January 2020. http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT04228146.

In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic.

STUDY OBJECTIVES: Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design. METHODS: A cohort of 63 Veterans Affairs (VA) mental health providers delivered CBT-I to 180 veterans as part of an evidence-based psychotherapy training program and captured de-identified treatment outcome data through a data portal. The main patient outcomes were change in the Insomnia Severity Index (ISI) total score from the initial clinical assessment session to the last treatment session, response rate (% with ISI change > 7 from assessment to last session), and remission rate (% with ISI < 8 at the last session). We tested the noninferiority of telehealth only compared with at least 1 in-person session. RESULTS: Fifty-six percent of veterans seen for an evaluation completed CBT-I treatment during the structured training program phase and completed an initial and final ISI. Among these veterans, ISI scores decreased by an average of 9.9 points from before to after treatment (P < .001), 66% experienced a clinically meaningful treatment response, and 43% experienced insomnia symptom remission. Benefits were similar whether the veteran received some in-person care or received CBT-I entirely via telehealth. CONCLUSIONS: Findings suggest, regardless of treatment modality, CBT-I remained highly effective during the early months of the pandemic, which was a challenging time for both clinical providers and veterans in need of insomnia treatment. CITATION: Martin JL, DeViva J, McCarthy E, et al. In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. J Clin Sleep Med. 2023;19(7):1211-1217.

Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia.

Background and Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I). Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018. Results: A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by =>7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score <8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (-53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P=0.389) and hospital outpatient visits (-13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P=0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P=0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index (P= 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient. Conclusion: In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.

Public interest and awareness regarding general health, sleep quality and mental wellbeing during the early COVID-19 pandemic period: An exploration using Google trends.

The internet network continues to be a major source of health-related information. Our research provides insights into the online health-seeking behaviors of the general population, and evaluates the potential relationship between the COVID-19 pandemic and public interest and awareness of general sleep health, mental health and wellbeing. Google Trends' weekly relative search volumes (RSVs) were examined during 2020 for searches specifically related to COVID-19 symptoms, and for searches related to general health, sleep and wellbeing, in the United Kingdom, the United States of America, France, Italy and Japan. To obtain insight into the association between the initiation of public restrictions and online search trends, we assessed a six-week period; the 'early pandemic period' (EPP) (01 March 2020 - 11 April 2020). To provide a meaningful pre-pandemic comparison, a similar period during 2019 (03 March - 13 April 2019) was compared for RSV and median difference analysis. The EPP was associated with increased online searches related to COVID-19 symptoms, as compared with those related to more general sleep health, mental health and wellbeing. The latter search terms frequently showed a decrease or minimal change in RSV during the EPP compared with the equivalent period in 2019. This finding illustrates the potential link between the COVID-19 pandemic and online search behavior and corroborates existing findings regarding internet searches during this period. Proactive communication by healthcare professionals during future pandemics and as an ongoing measure could help prevent public neglect of general health and wellbeing symptoms, and encourage reporting and early intervention.

Efficacy of simplified-cognitive behavioral therapy for insomnia(S-CBTI) among female COVID-19 patients with insomnia symptom in Wuhan mobile cabin hospital.

BACKGROUND: The outbreak of Coronavirus Disease-2019 (COVID-19) caused great psychological distress often with comorbid insomnia. Insomnia is common in patients with COVID-19 admitted to mobile cabin hospitals. Insomnia may lead to immune dysfunction, a condition not conducive to recovery from COVID-19. The use of sedative-hypnotic drugs is limited by their inhibitory effect on the respiratory system. A paucity of research is available regarding psychotherapy interventions to improve insomnia symptoms among  patients with COVID-19. In the general population, sleep problems are more common in women than in men; insomnia in women patients requires special attention. The aim of this study was to develop simplified-cognitive behavioral therapy for insomnia (S-CBTI) for patients with COVID-19 and comorbid insomnia symptoms and to verify its effectiveness through a self-control trial. A second aim was to compare the effectiveness of S-CBTI between acute and chronic insomnia among women with COVID-19 and comorbid insomnia symptoms in Wuhan Jianghan Cabin Hospital. METHODS: S-CBTI consisted of education on COVID-19 and sleep hygiene, stimulus control, sleep restriction, and self-suggestion relaxation training over a period of two consecutive weeks. Of 67 women, 66 completed psychological intervention and baseline and post-intervention assessments. There were 31 women with acute insomnia and 35 with chronic insomnia. The Insomnia Severity Index (ISI) score and self-compiled sleep data were assessed at baseline and post-intervention, and subjective sleep evaluations were assessed at days 4, 7, 12, and 14. RESULTS: The ISI score, sleep latency, night sleep time, and sleep efficiency were statistically significantlly improved from baseline to post-intervention by paired T-test. After the intervention, the mean ISI score of the acute insomnia group was lower than that of the chronic insomnia group. The reduction of the ISI score and the improvement of sleep time from baseline to post-intervention in the acute insomnia group were greater than those in the chronic insomnia group. Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant. CONCLUSIONS: S-CBTI can improve the insomnia symptoms of women with COVID-19 in mobile cabin hospitals, especially for stress-related acute insomnia.

Modularized iCBT­I self-learn training for university staff-prevention and early intervention in the SARS-CoV-2 crisis: A pilot study.

Background: Insomnia is a widespread disease in adults and has a high prevalence rate. As sleep disturbances are a risk factor concerning mental and physical health, prevention and early intervention are necessary. Thus, the aim of this study was to implement a self-learning prevention and early intervention training for university staff members. We adapted an established cognitive behavioral therapy for insomnia (CBT-I) intervention as an online version for use during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) crisis. Methods: Development and adaptation procedure of the internet-based CBT­I (iCBT-I) prevention and early intervention training is described. Sessions and topics are shown in detail. The Online Sleep Prevention and Treatment Acceptance questionnaire (OSTA) and the Online Sleep Prevention and Treatment Feedback questionnaire (OSTF) were used to assess acceptance. Sleep problems of university staff members were assessed using the Pittsburgh Sleep Questionnaire (PSQI). Results: The online-adapted version consisted of seven modules. Contents of sessions and topics were implemented based on video clips. Drawings were added to information regarding sleep and sleep hygiene as well as addressing stress and cognitions. In all, 15 individuals participated in this pilot study. The new iCBT­I self-learning prevention training was well accepted. In addition, participants scored the online version as helpful based on the OSTA. Prior to online training, 89% of the participants reported impaired sleep quality or insomnia symptoms, and 56% had a PSQI score over 10. After training 78% of participants showed reduced sleep problems according to PSQI and 56% reached clinically significant enhancement. In addition, after training 44% were healthy sleepers. Discussion: This is the first iCBT­I prevention and early intervention training for university staff members. The training by participants was very well accepted and they scored the videos as very helpful. Sleep problems decreased after online training. However, further studies with larger samples and more sleep-related assessment strategies, e.g., actigraphy and sleep log, are necessary.

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.

Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.