Clinically sufficient classification accuracy and key predictors of treatment failure in a randomized controlled trial of Internet-delivered Cognitive Behavior Therapy for Insomnia.
Ontology highlight
ABSTRACT: Background
In Adaptive Treatment Strategies, each patient's outcome is predicted early in treatment, and treatment is adapted for those at risk of failure. It is unclear what minimum accuracy is needed for a classifier to be clinically useful. This study aimed to establish a empirically supported benchmark accuracy for an Adaptive Treatment Strategy and explore the relative value of input predictors.Method
Predictions from 200 patients receiving Internet-delivered cognitive-behavioral therapy in an RCT was analyzed. Correlation and logistic regression was used to explore all included predictors and the predictive capacity of different models.Results
The classifier had a Balanced accuracy of 67 %. Eleven out of the 21 predictors correlated significantly with Failure. A model using all predictors explained 56 % of the outcome variance, and simpler models between 16 and 47 %. Important predictors were patient rated stress, treatment credibility, depression change, and insomnia symptoms at week 3 as well as clinician rated attitudes towards homework and sleep medication.Conclusions
The accuracy (67 %) found in this study sets a minimum benchmark for when prediction accuracy could be clinically useful. Key predictive factors were mainly related to insomnia, depression or treatment involvement. Simpler predictive models showed some promise and should be developed further, possibly using machine learning methods.
SUBMITTER: Forsell E
PROVIDER: S-EPMC9253627 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Background:Cognitive-behavioral therapy for insomnia (CBTi) is considered the standard treatment. The internet has proven to be a useful and successful tool of providing CBTi. However, few studies have investigated the possible effect of unguided internet-delivered CBTi (ICBTi) on comorbid psychological symptoms and fatigue. Methods:Based on a randomized controlled trial, we investigated whether unguided ICBTi had an effect on comorbid psychological symptoms. Adults with insomnia (n?=?181; 67% women; mean age 44.9?years [SD 13.0]) were randomized to ICBTi (n?=?95) or to an online patient education condition (n?=?86) for a nine-week period. Results:The results from mixed linear modelling yielded medium to large between-group effect sizes from pre- to post-treatment for symptoms of anxiety or depression (d?=?-0.57; 95% CI?=?0.79-0.35) and fatigue (d?=?0.92; 95% CI?=?1.22-0.62). The ICBTi group was reassessed at a 6-month non-randomized follow-up, and the completing participants had on the average a significant increase (from the post-assessment) on symptoms of anxiety or depression, while the reduction in symptoms of fatigue (on post-assessment) was maintained. However, due to high dropout attrition and no control group data, caution should be made regarding the long-term effects. In conclusion, the present findings show that unguided ICBTi positively influence comorbid symptoms in the short-term, thereby emphasizing the clinical relevance of unguided ICBTi. Trial registration:ClinicalTrials.gov identifier: NCT02261272.
| S-EPMC6096334 | biostudies-literature
Project description:Our aim was to compare the effects of Internet-delivered cognitive therapy (CT) and behavior therapy (BT) against a waitlist (WL) condition to better understand their unique contribution in the treatment of insomnia. Two hundred and nineteen participants with insomnia disorder were randomized to CT (n = 72), BT (n = 73), or WL (n = 74). The treatment arms consisted of 10 weekly internet-delivered modules with 15 min of telephone support per week. At pre, post, and follow-up, participants completed measures of insomnia severity, sleep diaries, functional impairment, anxiety, depression, quality of life, adverse events, satisfaction and perception of content, workload, and activity in treatment. Measures of completed exercises, modules, therapist support, and platform logins were also measured at posttreatment. Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups. Both treatment groups had significantly larger proportion of treatment remitters (CT: 35.8%, BT: 40%, WL: 2.7%) and responders (CT: 74.6%, BT 58.6%, WL: 10.8%) compared to the WL at posttreatment. There were no significant differences between the two therapy groups in terms of outcomes, except for sleep onset latency in favor of BT (6 min difference at posttreatment) and adverse events in favor of CT (CT 14.1% vs BT 43.2%). This study indicates that both Internet-delivered CT and BT are effective as stand-alone therapies for insomnia disorder. Results highlight the need for examining which therapy and subcomponents that are necessary for change. NCT02984670.
| S-EPMC7017953 | biostudies-literature
Project description:BACKGROUND:Previous attempts to identify predictors of treatment outcomes in body dysmorphic disorder (BDD) have yielded inconsistent findings. One way to increase precision and clinical utility could be to use machine learning methods, which can incorporate multiple non-linear associations in prediction models. METHODS:This study used a random forests machine learning approach to test if it is possible to reliably predict remission from BDD in a sample of 88 individuals that had received internet-delivered cognitive behavioral therapy for BDD. The random forest models were compared to traditional logistic regression analyses. RESULTS:Random forests correctly identified 78% of participants as remitters or non-remitters at post-treatment. The accuracy of prediction was lower in subsequent follow-ups (68, 66 and 61% correctly classified at 3-, 12- and 24-month follow-ups, respectively). Depressive symptoms, treatment credibility, working alliance, and initial severity of BDD were among the most important predictors at the beginning of treatment. By contrast, the logistic regression models did not identify consistent and strong predictors of remission from BDD. CONCLUSIONS:The results provide initial support for the clinical utility of machine learning approaches in the prediction of outcomes of patients with BDD. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT02010619.
| S-EPMC7238519 | biostudies-literature
Project description:Insomnia and depression is a common and debilitating comorbidity, and treatment is usually given mainly for depression. Guided Internet-based cognitive behavioral therapy for insomnia (ICBT-i) was, in a recent study on which this report is based, found superior to a treatment for depression (ICBT-d) for this patient group, but many patients did not reach remission. Aims:To identify facilitating and hindering factors for patients in ICBT-i and ICBT-d and formulate hypotheses for future research. Method:Qualitative telephone interviews at the time of the 6-month follow-up. Thirty-five interviews were done and analyzed with a grounded theory approach. Based on the qualitative results, an iterative method-triangulation including quantitative and semi-qualitative was performed. Results:The interviews were coded into 738 sentences, condensed into 47 categories and finally 11 themes. Four areas were investigated further with method triangulation: Opinions about treatment, adherence, hindering symptoms and acceptance. Patients in ICBT-i were more positive regarding the treatment than patients in ICBT-d. Using treatment components was positively associated with outcome in both groups. Symptoms of insomnia, depression and other comorbidities were perceived as more hindering for ICBT-d than for ICBT-i. Acceptance of diagnose-related problems as well as negative emotions and cognitions was positively associated with outcome for ICBT-i. Proposed future research hypotheses:1) A combination of CBT for insomnia and CBT for depression is more effective than only one of the treatments. 2) Additional therapist support increases outcomes for patients with more comorbidities. 3) Acceptance is a mechanism of change in CBT-i.
| S-EPMC6096295 | biostudies-literature
Project description:BackgroundInsomnia is of major public health importance. While cognitive behavioral therapy is beneficial, in-person treatment is often unavailable. We assessed the effectiveness of internet-delivered cognitive behavioral therapy for insomnia.ObjectivesThe primary objectives were to determine whether online cognitive behavioral therapy for insomnia could improve sleep efficiency and reduce the severity of insomnia in adults. Secondary outcomes included sleep quality, total sleep time, time in bed, sleep onset latency, wake time after sleep onset, and number of nocturnal awakenings.Data sourcesWe searched PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, PsycInfo, Cochrane Library, Embase, and the Web of Science for randomized trials.MethodsStudies were eligible if they were randomized controlled trials in adults that reported application of cognitive behavioral therapy for insomnia via internet delivery. Mean differences in improvement in sleep measures were calculated using the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis.ResultsWe found 15 trials, all utilizing a pretest-posttest randomized control group design. Sleep efficiency was 72% at baseline and improved by 7.2% (95% CI: 5.1%, 9.3%; p<0.001) with internet-delivered cognitive behavioral therapy versus control. Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0.017) compared to control. Total sleep time averaged 5.7 hours at baseline and increased by 20 minutes with internet-delivered therapy versus control (95% CI: 9, 31; p = 0.004). The severity of depression decreased by 2.3 points (95% CI: -2.9, -1.7; p = 0.013) in individuals who received internet-delivered cognitive behavioral therapy compared to control. Improvements in sleep efficiency, the insomnia severity index and depression scores with internet-delivered cognitive behavioral therapy were maintained from 4 to 48 weeks after post-treatment assessment. There were no statistically significant differences between sleep efficiency, total sleep time, and insomnia severity index for internet-delivered versus in-person therapy with a trained therapist.ConclusionIn conclusion, internet-delivered cognitive behavioral therapy is effective in improving sleep in adults with insomnia. Efforts should be made to educate the public and expand access to this therapy. Registration Number, Prospero: CRD42015017622.
| S-EPMC4750912 | biostudies-literature
Project description:BackgroundPatients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.ObjectiveThis randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.MethodsWe included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.ResultsResults showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.ConclusionsIn patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.Trial registrationClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.
| S-EPMC9107050 | biostudies-literature
Project description:Background:Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge. Internet-delivered CBT-I (iCBT-I) has been shown efficacious in otherwise healthy adults. We tested the efficacy of iCBT-I in breast cancer survivors with clinically significant sleep disturbance. Methods:Women from a national sample of Danish breast cancer survivors who experienced clinically significant sleep disturbance were randomly allocated to iCBT-I or waitlist control (55:45). The fully automated iCBT-I program consisted of six cores. Online measures of insomnia severity, sleep quality, and fatigue were collected at baseline, postintervention (nine weeks), and follow-up (15 weeks). Online sleep diaries were completed over two-week periods pre- and postintervention. Intention-to-treat analyses (time × group interactions) were conducted with mixed linear models and corrected for multiple outcomes. All statistical tests were two-sided. Results:A total of 255 women were randomly allocated to iCBT-I (n = 133) or waitlist control (n = 122). Statistically significant (P ≤ .02) time × group interactions were found for all sleep-related outcomes from pre- to postintervention. Effect sizes (Cohen's d) ranged from 0.33 (95% confidence interval [CI] = 0.06 to 0.61) for wake after sleep onset to 1.17 (95% CI = 0.87 to 1.47) for insomnia severity. Improvements were maintained for outcomes measured at follow-up (d = 0.66-1.10). Conclusions:iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue. This low-cost treatment could be incorporated in cancer rehabilitation programs.
| S-EPMC6093474 | biostudies-literature
Project description:ImportanceAtopic dermatitis is a common and debilitating skin condition characterized by intense itching and chronic inflammation. Research on behavioral treatments with high accessibility is needed.ObjectiveTo investigate the efficacy of a highly scalable internet-delivered cognitive behavior therapy (CBT) for adults with atopic dermatitis.Design, setting, and participantsThis randomized clinical trial from a medical university in Stockholm, Sweden, included 102 adults with atopic dermatitis, recruited from across Sweden, who received 12 weeks of internet-delivered CBT (March 29, 2017, to February 16, 2018). The first participant provided screening data on November 27, 2016, and the last 1-year follow-up assessment was conducted on June 28, 2019.InterventionsParticipants were randomized in a 1:1 ratio to 12 weeks of therapist-guided internet-delivered CBT (n = 51) or a control condition (n = 51) that gave instructions about standard care.Main outcomes and measuresThe primary outcome was the between-group difference in mean reduction of atopic dermatitis symptoms as measured by the Patient-Oriented Eczema Measure and modeled intention to treat during the 12-week treatment period.ResultsA total of 102 participants (mean [SD] age, 37 [11] years; 83 [81%] female) were recruited and randomized. The primary analysis indicated that participants receiving internet-delivered CBT, relative to the controls, had a significantly larger mean weekly reduction in symptoms of atopic dermatitis as measured with the Patient-Oriented Eczema Measure (B = 0.32; 95% CI, 0.14-0.49; P < .001), with a moderate to large, controlled effect size after treatment (d = 0.75; 95% CI, 0.32-1.16). Secondary analyses indicated that internet-delivered CBT also produced significantly larger reductions in itch intensity, perceived stress, sleep problems, and depression. Gains were sustained at 12 months of follow-up. Treatment satisfaction was high, and therapists spent a mean (SD) of 39.7 (34.7) minutes per treated patient providing internet-delivered CBT.Conclusions and relevanceInternet-delivered CBT appears to be efficacious for reducing symptoms of atopic dermatitis, despite requiring minimal therapist resources. Thus, internet-delivered CBT has the potential to increase access to effective adjunct behavioral treatment for patients with this common skin condition.Trial registrationClinicalTrials.gov Identifier: NCT03051958.
| S-EPMC8135053 | biostudies-literature
Project description:ImportanceBlack women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population.ObjectiveTo compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms.Design, setting, and participantsIn this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women's Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study.InterventionsParticipants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep.Main outcomes and measuresThe primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE.ResultsA total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: -10.0 points; 95% CI, -11.2 to -8.7; SHUTi-BWHS: -9.3 points; 95% CI, -10.4 to -8.2) than those randomized to receive PE (-3.6 points; 95% CI, -4.5 to -2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (-10.4 points [95% CI, -11.4 to -9.4] vs -6.2 points [95% CI, -8.6 to -3.7]).Conclusions and relevanceIn this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep.Trial registrationClinicalTrials.gov Identifier: NCT03613519.
| S-EPMC9021979 | biostudies-literature
Project description:BACKGROUND:Depression is a highly prevalent mental health issue that exacts significant economic, societal, personal, and interpersonal costs. Innovative internet-delivered interventions have been designed to increase accessibility to and cost-effectiveness of treatments. These treatments have mainly targeted mild to moderate levels of depression. The increased risk associated with severe depression, particularly of suicidal ideation often results in this population being excluded from research studies. As a result, the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) in more severely depressed cohorts is less researched. OBJECTIVE:The aim of this study is to examine the effect of iCBT on symptoms of severe depression, comorbid symptoms of anxiety, and levels of work and social functioning. METHODS:Retrospective consent was provided by participants with elevated scores (>28 severe depression symptoms) on the Beck Depression Inventory (BDI-II) who accessed an iCBT intervention (Space from Depression) with support for up to 8 weeks. Data were collected at baseline, posttreatment, and 3-month follow-up on the primary outcome (BDI-II), and secondary outcomes (the Generalized Anxiety Disorder-7 and the Work and Social Adjustment Scale). RESULTS:A significant change was observed on all measures between pre- and postmeasurement and maintained at 3-month follow-up. Clinical improvement was observed for participants on the BDI-II from pre- to postmeasurement, and suicidal ideation also reduced from pre- to postmeasurement. CONCLUSIONS:Users of Space from Depression with symptoms of severe depression were found to have decreased symptoms of depression and anxiety and increased levels of work and social functioning. The intervention also demonstrated its potential to decrease suicidal ideation. Further investigation is required to determine why some individuals improve, and others do not. iCBT may have the potential to be used as an adjunct treatment for severe depression symptoms, but participants may require further treatment if they receive iCBT as a standalone intervention. Although promising, further research incorporating control groups is needed to support the utility of Space from Depression for use in or as an adjunct to treatment for severe depression.
| S-EPMC6231851 | biostudies-other