Dataset Information

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

ABSTRACT:

Importance

Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.

Objective

To investigate the efficacy of a smartphone-based Chinese culture-adapted DCBT-I application (app) for insomnia compared with sleep education using the same app.

Design, setting, and participants

This was a single-blinded, randomized clinical trial conducted from March 2021 to January 2022. Screening and randomization were conducted at Peking University First Hospital. Follow-up visits were performed online or in the same hospital. After assessing for eligibility, eligible participants were enrolled and allocated (1:1) to DCBT-I or sleep education groups. Data were analyzed from January to February 2022.

Interventions

A Chinese smartphone-based app with the same interface was used in both DCBT-I and sleep education groups over 6 weeks, with 1-, 3-, and 6-month follow-ups.

Main outcomes and measures

The primary outcome was Insomnia Severity Index (ISI) scores with the intention-to-treat principle. Secondary and exploratory outcomes included sleep diary measures; self-reported scales assessing dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures.

Results

Of 82 participants (mean [SD] age, 49.67 [14.49] years; 61 [74.4%] females), with 41 randomized to sleep education and 41 randomized to DCBT-I; 77 participants completed the 6-week intervention (39 participants in the sleep education group and 38 participants in the DCBT-I group; full analysis data set) and 73 completed the 6-month follow-up (per protocol data set). Mean (SD) ISI scores in the DCBT-I group were significantly lower than those in the sleep education group after the 6-week intervention (12.7 [4.8] points vs 14.9 [5.0] points; Cohen d = 0.458; P = .048) and at the 3-month follow-up (12.1 [5.4] points vs 14.8 [5.5] points; Cohen d = 0.489; P = .04). There were significant improvements from before to after the intervention for both the sleep education and DCBT-I groups, with large effect sizes(sleep education: d = 1.13; DCBT-I: d = 1.71). Some of the sleep diary measures and self-reported scales showed more improvements in the DCBT-I group than sleep education group, such as total sleep time (mean [SD]: 3 months, 403.9 [57.6] minutes vs 363.2 [72.3] minutes; 6 months, 420.3 [58.0] minutes vs 389.7 [59.4] minutes) and sleep efficiency (mean [SD]: 3 months, 87.4% [8.3%] vs 76.7% [12.1%]; 6 months, 87.5% [8.2%] vs 78.1% [10.9%]).

Conclusions and relevance

In this randomized clinical trial, the smartphone-based Chinese culture-adapted DCBT-I improved insomnia severity compared with sleep education. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness in the Chinese population.

Trial registration

ClinicalTrials.gov Identifier: NCT04779372.

SUBMITTER: Zhang C

PROVIDER: S-EPMC10043748 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

Zhang Cheng C Liu Yuxuan Y Guo Xiaoming X Liu Yanan Y Shen Yane Y Ma Jing J

JAMA network open 20230301 3

<h4>Importance</h4>Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.<h4>Objective</h4>To investigate the efficacy of a smartphone-based Chinese culture-adapted DCBT-I application (app) for insomnia compared with sleep education using the same app.<h4>Design, setting, and participants</h4>This was a single-blinded, randomized clinica ...[more]

PMID: 36972049

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Project description:BackgroundThe overall prevalence of cigarette smokers in China is very high, and China's total cigarette consumption makes up more than 40% of the world's consumption. In view of the lack of smoking cessation services and social support in China and the effectiveness of mobile phone apps for quitting smoking in other countries, we carried out a smartphone app-based smoking cessation trial in China.ObjectiveThis study aimed to evaluate the efficacy of a cognitive behavioral therapy (CBT)-based smoking cessation smartphone app among smokers seeking treatment in China.MethodsWe conducted a randomized controlled, web-based pilot clinical trial in China between February 23 and June 27, 2021. Eligible participants were randomly assigned to the smoking cessation app intervention group or the control group in a ratio of 1:1. The intervention group received the CBT smoking cessation intervention using a smartphone app, and the control group received a "thank you" message. The intervention was 4 weeks long, and the patients were followed up for 4 weeks. The primary outcome was self-reported continuous smoking abstinence at week 4 after the quit date. The secondary outcomes included self-reported 7-day point prevalence of smoking abstinence; reduction of the number of cigarettes smoked per day at weeks 1, 2, 3, and 4; and program acceptability.ResultsA total of 973 people were recruited to quit smoking, of whom 262 completed basic information, 56 were excluded, and 206 were randomized and included in the final analysis. There were 189 (91.7%) men and 17 (8.3%) women, with an average age of 34.46 (SD 7.53) years and an average daily smoking rate of 15.93 (SD 7.10) cigarettes/day. We found 30 (29.7%) of the 101 participants in the intervention group and 7 (6.7%) of the 105 participants in the control group reported continuous smoking cessation after the quit date at week 4 (odds ratio 5.92, 95% CI 3.78-9.26; P<.001). The 7-day point prevalence abstinence rate of the intervention group varied from 42.6% (43/101) to 46.5% (47/101) after 1, 2, 3, and 4 weeks, while the control group varied from 18.1% (19/105) to 26.7% (28/105). Compared to the control group, continued smokers consumed 1.5-3.0 fewer cigarettes per day in the intervention group. The overall program got positive user feedback with a high satisfaction rate (66/87, 76%) and an average Mobile Application Rating Scale user version score of 3.46.ConclusionsOur pilot study provided preliminary evidence that the CBT-based smoking cessation smartphone app led to improved smoking quit rates versus control in Chinese smokers. The study demonstrated the CBT-based smartphone app may be an effective and feasible digital treatment model to help smokers quit, which may improve smoking cessation service quality and accessibility in China.Trial registrationClinicalTrials.gov NCT04421170; https://clinicaltrials.gov/study/NCT04421170.International registered report identifier (irrid)RR2-10.1136/bmjopen-2020-041985.

Project description:BackgroundDigital interventions delivering Cognitive Behavioral Therapy for insomnia (Digital CBTi) may increase utilization of effective care for a common and serious condition. A low-intensity implementation strategy may facilitate digital CBTi use in healthcare settings. This pilot study assessed the feasibility of implementing a digital CBTi in Veterans Health Administration (VA) primary care through iterative modifications to a low-intensity implementation strategy, while evaluating clinical outcomes of a specific digital CBTi program.MethodsA self-directed digital CBTi was implemented in the primary care clinics of a single VA facility using a cohort trial design that iteratively modified an implementation strategy over three 8-month phases. The phase 1 implementation strategy included (1) provider education; (2) point-of-care information via pamphlets; and (3) provider referral to digital CBTi through phone calls or messages. Phases 2 and 3 maintained these activities, while (1) adding a clinic-based coach who performed initial patient education and follow-up support contacts, (2) providing additional recruitment pathways, and (3) integrating the referral mechanism into provider workflow. Implementation outcomes included provider adoption, patient adoption, and acceptability. Clinical outcomes (insomnia severity, depression severity, and sedative hypnotic use) were compared among enrollees at baseline and 10 weeks.ResultsAcross all phases 66 providers (48.9%) made 153 referrals, representing 0.38% of unique clinic patients. Of referrals, 77 (50.3%) enrolled in the study, 45 (29.4%) engaged in the program, and 24 (15.7%) completed it. Provider and patient adoption did not differ meaningfully across phases. Among enrollees, digital CBTi was acceptable and the Insomnia Severity Index decreased by 4.3 points (t = 6.41, p < 0.001) and 13 (18.6%) reached remission. The mean number of weakly sedative-hypnotic doses decreased by 2.2 (35.5%) (t = 2.39, p < 0.02).ConclusionsDigital CBTi implementation in VA primary care is feasible using low-intensity implementation strategy, resulting in improved clinical outcomes for users. However, iterative implementation strategy modifications did not improve adoption.The trial was registered at clinicaltrials.gov (NCT03151083).

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:ObjectiveTo evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.MethodsRandomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05.ResultsBetween May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group.ConclusionCognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy.Clinical trial registrationClinicalTrials.gov, NCT01846585.

Dataset Information

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

Similar Datasets

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