Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy.
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ABSTRACT: Study objectives
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.Methods
Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.Results
Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was -2.8 (95% CI: -4.8 to -0.8; p = 0.007, Cohen's d = 0.7), and -4.6 at week 9 (95% CI -6.6 to -2.7; p < 0.001), Cohen's d = 1.2.Conclusions
At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.
SUBMITTER: Kallestad H
PROVIDER: S-EPMC8664599 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:STUDY OBJECTIVES:Insomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period. METHODS:Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up. RESULTS:At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition. CONCLUSION:dCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention. CLINICAL TRIAL:Sleep to Prevent Evolving Affective Disorders; NCT02988375.
| S-EPMC6783888 | biostudies-literature
Project description:ObjectiveDespite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. 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 internet-based digital CBTI in pregnant women with insomnia.MethodsSingle-site RCT. A total of 91 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. 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, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.ResultsFrom pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.ConclusionsDigital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.
| S-EPMC8210706 | biostudies-literature
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.
| S-EPMC6485299 | biostudies-literature
Project description:To compare the efficacy of guided online and individual face-to-face cognitive behavioral treatment for insomnia (CBT-I) to a wait-list condition.A randomized controlled trial comparing three conditions: guided online; face-to-face; wait-list. Posttest measurements were administered to all conditions, along with 3- and 6-mo follow-up assessments to the online and face-to-face conditions. Ninety media-recruited participants meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia were randomly allocated to either guided online CBT-I (n = 30), individual face-to-face CBT-I (n = 30), or wait-list (n = 30).At post-assessment, the online (Cohen d = 1.2) and face-to-face (Cohen d = 2.3) intervention groups showed significantly larger treatment effects than the wait-list group on insomnia severity (insomnia severity index). Large treatment effects were also found for the sleep diary estimates (except for total sleep time), and anxiety and depression measures (for depression only in the face-to-face condition). Face-to-face treatment yielded a statistically larger treatment effect (Cohen d = 0.9) on insomnia severity than the online condition at all time points. In addition, a moderate differential effect size favoring face-to-face treatment emerged at the 3- and 6-mo follow-up on all sleep diary estimates. Face-to-face treatment further outperformed online treatment on depression and anxiety outcomes.These data show superior performance of face-to-face treatment relative to online treatment. Yet, our results also suggest that online treatment may offer a potentially cost-effective alternative to and complement face-to-face treatment.Clinicaltrials.gov, NCT01955850.A commentary on this article appears in this issue on page 13.
| S-EPMC4678352 | biostudies-literature
Project description:Sleep disturbance is common in the working population, often associated with work stress, health complaints and impaired work performance. This study evaluated a group intervention at work, based on cognitive behavioral therapy (CBT) for insomnia, and the moderating effects of burnout scores at baseline.This is a randomized controlled intervention with a waiting list control group. Participants were employees working at least 75% of full time, reporting self-perceived regular sleep problems. Data were collected at baseline, post-intervention and at a 3-month follow-up through diaries, wrist-actigraphy and questionnaires including the Insomnia Severity Index (ISI) and the Shirom-Melamed Burnout Questionnaire (SMBQ). Fifty-one participants (63% women) completed data collections.A multilevel mixed model showed no significant differences between groups for sleep over time, while there was a significant effect on insomnia symptoms when excluding participants working shifts (N?=?11) from the analysis (p?=?0.044). Moreover, a moderating effect of baseline-levels of burnout scores was observed on insomnia symptoms (p?=?0.009). A post-hoc analysis showed that individuals in the intervention group with low burnout scores at baseline (SMBQ?<?3.75) displayed significantly reduced ISI scores at follow-up, compared to individuals with high burnout scores at baseline (p?=?0.005).Group CBT for insomnia given at the workplace did not reduce sleep problems looking at the group as a whole, while it was indicated that the intervention reduced insomnia in employees with regular daytime work. The results also suggest that workplace-based group CBT may improve sleep in employees with primary insomnia if not concomitant with high burnout scores.
| S-EPMC5908834 | biostudies-other
Project description:Study objectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this non-inferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: 1) StanCBT-I (6 face-to-face CBT-I sessions; n=59); or 2) StepCBT-I (n=118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n=65), while those with a more severe insomnia received 6 face-to-face CBT-I sessions (n=53). In both cases, patients could receive up to 3 booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that were not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps<.001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.
| S-EPMC8598200 | biostudies-literature
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.
| S-EPMC7078631 | biostudies-literature
Project description:Background: Face-to-face cognitive behavioral therapy (CBT) is one of the most widely used non-pharmacological treatment approaches for insomnia. The aim of this study is to assess the efficacy of face-to-face delivered CBT on health outcomes and to evaluate the effect of CBT components as subgroup variables to explain the efficacy of face-to-face delivered CBT on health outcomes in adults over 18 years old with insomnia. Methods: Relevant randomized controlled trial studies published in the past 22 years were searched through the electronic databases. The Physiotherapy Evidence Database (PEDro) scale was used to assess the quality of the 31 included studies. The mean difference and standard deviation of outcome variables and subgroup variables were analyzed using random effect model, and the heterogeneity among the articles was assessed with the Q-test and I 2. Egger regression analysis was used to assess publication bias. Results: The meta-analysis showed a significant reduction in Insomnia Severity Index [standardized mean difference (SMD) = -2.56, 95% CI -3.81 to -1.30, p < 0.001], Pittsburgh Sleep Quality Index (SMD = -0.96, 95% CI -1.25 to -0.68, p < 0.001), sleep onset latency (SMD = -1.31, 95% CI -2.00 to -0.63, p < 0.001), wakening after sleep onset (SMD = -1.44, 95% CI -2.14 to -0.74, p < 0.001), number of awakenings (SMD = -1.18, 95% CI -2.10 to -0.26, p < 0.05), depression (SMD = -1.14, 95% CI -1.85 to -0.42, p < 0.01), and fatigue (SMD = -2.23, 95% CI -3.87 to -0.58, p < 0.01), and a significant increase in total sleep time (SMD = 0.63, 95% CI 0.28 to 0.98, p < 0.001), sleep efficiency (SMD = 1.61, 95% CI 0.92 to 2.29, p < 0.001), and physical health (SMD = 0.42, 95% CI 0.08 to 0.76, p < 0.05), in the CBT intervention group compared with the control group. There was no significant change in anxiety (SMD = -0.62, 95% CI -1.55 to 0.32, p > 0.05) and mental health (SMD = 1.09, 95% CI -0.59 to 2.77, p > 0.05) in CBT intervention group compared with control group. Group-delivered studies with larger number of intervention sessions and longer duration of single session provided a larger improvement in sleep quality. Conclusion: Face-to-face delivered CBT is effective in increasing total sleep time, sleep efficiency, and physical health, and reducing Insomnia Severity Index scores, Pittsburgh Sleep Quality Index scores, sleep onset latency, wakening after sleep onset, number of awakenings, depression, anxiety, and fatigue in patients with insomnia. Face-to-face delivered CBT is more effective when delivered through a larger number of sessions with longer duration of each session, and when delivered in groups. Face-to-face CBT is recommended to provide treatment to patients with insomnia in clinical settings. Systematic Review Registration: www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020200091, identifier: CRD4202020009.
| S-EPMC8733003 | biostudies-literature
Project description:BACKGROUND:Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE:This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS:A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS:We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. CONCLUSIONS:Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. TRIAL REGISTRATION:University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).
| S-EPMC6231848 | biostudies-other
Project description:Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning.RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS: CBT-I and monitor-only waitlist control.Department of Veterans Affairs (VA) Medical Center.Forty-five adults (31 females: [mean age 37 y (22-59 y)] with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females).Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist.Measures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares.Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine.TRIAL NAME: Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder. URL: http://clinicaltrials.gov/ct2/show/NCT00881647.NCT00881647.
| S-EPMC3900619 | biostudies-literature