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Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms.

ABSTRACT: BACKGROUND:Insomnia is effectively treated with online Cognitive Behavioral Therapy for Insomnia (CBT-I). Previous research has suggested the effects might not be limited to sleep and insomnia severity, but also apply to depressive symptoms. Results, however, are mixed. METHODS:In this randomized controlled trial we investigated the effects of guided online CBT-I on depression and insomnia in people suffering from symptoms of both. Participants (n = 104) with clinical insomnia and at least subclinical depression levels were randomized to (1) guided online CBT-I and sleep diary monitoring (i-Sleep) or (2) control group (sleep diary monitoring only). The primary outcome was the severity of depressive symptoms (Patient Health Questionnaire-9 without sleep item; PHQ-WS). Secondary outcomes were insomnia severity, sleep diary parameters, fatigue, daytime consequences of insomnia, anxiety, and perseverative thinking. RESULTS:At post-test, participants in the i-Sleep condition reported significantly less depressive symptoms (PHQ-WS) compared with participants in the sleep-diary condition (d = 0.76). Large significant effects were also observed for insomnia severity (d = 2.36), most sleep diary parameters, daytime consequences of insomnia, anxiety, and perseverative thinking. Effects were maintained at 3 and 6 month follow-up. We did not find significant post-test effects on fatigue or total sleep time. CONCLUSIONS:Findings indicate that guided online CBT-I is not only effective for insomnia complaints but also for depressive symptoms. The effects are large and comparable with those of depression therapy. CLINICAL TRIAL REGISTRATION NUMBER:NTR6049 (Netherlands Trial Register).

SUBMITTER: van der Zweerde T

PROVIDER: S-EPMC6331685 | biostudies-other | 2019 Feb

REPOSITORIES: biostudies-other

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Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms.

van der Zweerde T T van Straten A A Effting M M Kyle S D SD Lancee J J

Psychological medicine 20180511 3

<h4>Background</h4>Insomnia is effectively treated with online Cognitive Behavioral Therapy for Insomnia (CBT-I). Previous research has suggested the effects might not be limited to sleep and insomnia severity, but also apply to depressive symptoms. Results, however, are mixed.<h4>Methods</h4>In this randomized controlled trial we investigated the effects of guided online CBT-I on depression and insomnia in people suffering from symptoms of both. Participants (n = 104) with clinical insomnia and ...[more]

PMID: 29747706

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Project description:BackgroundInsomnia symptoms are a common form of sleep difficulty among people with type 2 diabetes (T2D) affecting sleep quality and health outcomes. Several interventional approaches have been used to improve sleep outcomes in people with T2D. Nonpharmacological approaches, such as cognitive behavioral therapy for insomnia (CBT-I), show promising results regarding safety and sustainability of improvements, although CBT-I has not been examined in people with T2D. Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes.ObjectiveThe objective of this study is to establish a protocol for a pilot randomized controlled trial (RCT) to examine the effect of 6 sessions of CBT-I on insomnia severity (primary outcome), sleep variability, and other health-related outcomes in individuals with T2D and insomnia symptoms.MethodsThis RCT will use random mixed block size randomization with stratification to assign 28 participants with T2D and insomnia symptoms to either a CBT-I group or a health education group. Outcomes including insomnia severity; sleep variability; diabetes self-care behavior (DSCB); glycemic control (A1c); glucose level; sleep quality; daytime sleepiness; and symptoms of depression, anxiety, and pain will be gathered before and after the 6-week intervention. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will be used to examine the effect of the CBT-I intervention on change score means for insomnia severity, sleep variability, DSCB, A1c, fatigue, sleep quality, daytime sleepiness, and severity of depression, anxiety, and pain. For all analyses, alpha level will be set at .05.ResultsThis study recruitment began in February 2019 and was completed in September 2019.ConclusionsThe intervention, including 6 sessions of CBT-I, will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes-related health outcomes in people with T2D and those with insomnia symptoms when compared with control.Trial registrationClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996.International registered report identifier (irrid)DERR1-10.2196/14647.

Project description:Abstract:Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n?=?10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n?=?30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time. Trial registration:NCT#03493958; registered 1 June 2018.

Project description:Background and aims Given the widespread use of cannabis, and the concomitant risks associated with the drug, there is a need to increase the availability of interventions designed to reduce risky cannabis use. One promising intervention in the addictions employs personalized normative feedback to motivate change. Methods A two-arm randomized controlled trial (RCT) was conducted in which participants who used cannabis in a risky fashion were randomly assigned to one of two groups – those who received an online personalized feedback report in addition to educational materials about risky cannabis use and those who just received the online educational materials. Follow-up assessment occurred at three- and six-months post-randomization. Outcome variables included: number of days cannabis was used in the past 30, risky cannabis use (ASSIST score of four or more), and participant estimates of the proportion of cannabis users among those of the same age and gender. Results A total of 744 participants with risky cannabis use were recruited for the trial using online advertisements. There were no significant differences between intervention and educational materials only groups at three- and six-month follow-ups for the outcome variables, number of days used cannabis in the last 30 (p = 0.927) and proportion of participants engaging in risky cannabis use (p = 0.557). At three and six month follow-ups, participants who received the feedback intervention were more likely than those in the educational materials group to estimate that a larger proportion of people their age and gender did not use cannabis in the last year (p = 0.028). Discussion and conclusion While there was some evidence that the personalized feedback intervention modified normative perceptions about cannabis use, there did not appear to be support for the prediction that the intervention reduced cannabis consumption. Highlights • Personalized feedback intervention for risky cannabis use impacted normative misperceptions compared to educational control• Cannabis use did not appear to change as a result of providing individuals with a personalized feedback intervention

Project description:Depression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Therefore, we need effective and widely accessible strategies to prevent the onset of the very first depressive symptoms. Mental health apps could prove a valuable solution for this desideratum. Although preliminary research has indicated that such apps can be useful in treating depression, no study has attempted to test their utility in preventing depressive symptoms. The aim of this exploratory study is to contrast the efficacy of a smartphone app in reducing cognitive vulnerability and mild depressive symptoms, as risk factors for the onset of depression, against a wait-list condition. More specifically, we aim to test an app designed to (1) decrease general cognitive vulnerability and (2) promote engagement in protective, adaptive activities, while (3) counteracting (through gamification and customization) the tendency of premature dropout from intervention.Romanian-speaking adults (18 years and older) with access to a computer and the Internet and who own a smartphone are included in the study. Two parallel randomized clinical trials are conducted: in the first one, 50 participants free of depressive symptoms (i.e., who obtain scores ?4 on the Patient Health Questionnaire, PHQ-9) will be included, while in the second one 50 participants with minimal depressive symptoms (i.e., who obtain PHQ-9 scores between 5 and 9) will be included. Participants undergoing therapy, presenting with substance abuse problems, psychotic symptoms, and organic brain disorders, or serious legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active intervention will autonomously use the smartphone app for 4 weeks, while the others will be given access to the app after 4 weeks from randomization. The primary outcomes are (1) cognitive vulnerability factors as defined within the cognitive behavioral therapy (CBT) paradigm (i.e., dysfunctional cognitions, irrational beliefs, and negative automatic thoughts) (for the first trial), and (2) level of depressive symptomatology (for the second trial). The app includes self-help materials and exercises based on CBT for depression, presented in a tailored manner and incorporating gamification elements aimed at boosting motivation to use the app.This study protocol is the first to capitalize on the ubiquity of smartphones to large-scale dissemination of CBT-based strategies aimed at preventing depression in non-clinical populations.ClinicalTrials.gov: NCT02783118 . Registered on 26 May 2016.

Project description:ImportancePatients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.ObjectiveTo evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only.Design, setting, and participantsThis randomized clinical trial was conducted in primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver. Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018. Outcomes were assessed for a 15-month period, comprising a 3-month intervention interval and a 12-month follow-up period.InterventionsPatients were randomized to receive usual depression care (UDC; n?=?230) or MMB plus UDC (n?=?230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support.Main outcomes and measuresPrimary outcomes were reduction in residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores ?15); and rates of remission (PHQ-9 scores <5). Secondary outcomes included depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey).ResultsAmong 460 randomized participants (mean [SD] age, 48.30 [14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months. Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P?<?.02). A significantly greater proportion of patients achieved remission in the MMB plus UDC group compared with the UDC only group (PHQ-9 score, <5: ? [SE], 0.38 [0.14], P?=?.008), and rates of depressive relapse were significantly lower in the MMB plus UDC group compared with the UDC only group (hazard ratio, 0.61; 95% CI, 0.39-0.95; P?<?.03). Compared with the UDC only group, the MMB plus UDC group had decreased depression-free days (mean [SD], 281.14 [164.99] days vs 247.54 [158.32] days; difference, -33.60 [154.14] days; t?=?-2.33; P?=?.02), decreased anxiety (mean [SE] General Anxiety Disorder-7 Item Scale score, 1.21 [0.42], P?=?.004), and improved mental functioning (mean [SE] 12-Item Short Form Survey score, -5.10 [1.37], P?<?.001), but there was no statistically significant difference in physical functioning.Conclusions and relevanceUse of MMB plus UDC resulted in significant improvement in depression and functional outcomes compared with UDC only. The MMB web-based treatment may offer a scalable approach for the management of residual depressive symptoms.Trial registrationClinicalTrials.gov identifier: NCT02190968.

Dataset Information

Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms.

Publications

Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms.

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