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The Generalizability of Randomized Controlled Trials of Self-Guided Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms: Systematic Review and Meta-Regression Analysis.

ABSTRACT: BACKGROUND:Self-guided internet-based cognitive behavioral therapies (iCBTs) for depressive symptoms may substantially increase accessibility to mental health treatment. Despite this, questions remain as to the generalizability of the research on self-guided iCBT. OBJECTIVE:We sought to describe the clinical entry criteria used in studies of self-guided iCBT, explore the criteria's effects on study outcomes, and compare the frequency of use of these criteria with their use in studies of face-to-face psychotherapy and antidepressant medications. We hypothesized that self-guided iCBT studies would use more stringent criteria that would bias the sample toward those with a less complex clinical profile, thus inflating treatment outcomes. METHODS:We updated a recently published meta-analysis by conducting a systematic literature search in PubMed, MEDLINE, PsycINFO, and EMBASE. We conducted a meta-regression analysis to test the effect of the different commonly used psychiatric entry criteria on the treatment-control differences. We also compared the frequency with which exclusion criteria were used in the self-guided iCBT studies versus studies of face-to-face psychotherapy and antidepressants from a recently published review. RESULTS:Our search yielded 5 additional studies, which we added to the 16 studies identified by Karyotaki and colleagues in 2017. Few self-guided iCBT studies excluded patients with severe depressive symptoms (6/21, 29%), but self-guided iCBT studies were more likely than antidepressant (14/170, 8.2%) studies to use this criterion. However, self-guided iCBT studies did not use this criterion more frequently than face-to-face psychotherapy studies (6/16, 38%). Beyond this, we found no evidence that self-guided iCBTs used more stringent entry criteria. Strong evidence suggested that they were actually less likely to use most entry criteria, especially exclusions on the basis of substance use or personality pathology. None of the entry criteria used had an effect on outcomes. CONCLUSIONS:A conservative interpretation of our findings is that the patient population sampled in the literature on self-guided iCBT is relatively comparable with that of studies of antidepressants or face-to-face psychotherapy. Alternatively, studies of unguided cognitive behavioral therapy may sample from a more heterogeneous and representative patient population. Until evidence emerges to suggest otherwise, the patient population sampled in self-guided iCBT studies cannot be considered as less complex than the patient population from face-to-face psychotherapy or antidepressant studies.

SUBMITTER: Lorenzo-Luaces L

PROVIDER: S-EPMC6251981 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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The Generalizability of Randomized Controlled Trials of Self-Guided Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms: Systematic Review and Meta-Regression Analysis.

Lorenzo-Luaces Lorenzo L Johns Emily E Keefe John R JR

Journal of medical Internet research 20181109 11

<h4>Background</h4>Self-guided internet-based cognitive behavioral therapies (iCBTs) for depressive symptoms may substantially increase accessibility to mental health treatment. Despite this, questions remain as to the generalizability of the research on self-guided iCBT.<h4>Objective</h4>We sought to describe the clinical entry criteria used in studies of self-guided iCBT, explore the criteria's effects on study outcomes, and compare the frequency of use of these criteria with their use in stud ...[more]

PMID: 30413400

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Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:BackgroundMajor depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder.ObjectiveThe objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder.MethodsThe cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores.ResultsThe analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000.ConclusionsThe Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

Project description:BackgroundTinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States.ObjectiveThe aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention.MethodsA 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life.ResultsInternet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3.ConclusionsThis study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers.Trial registrationClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.

Project description:BACKGROUND:Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. OBJECTIVE:To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. METHODS:A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. RESULTS:Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). CONCLUSIONS:Findings will contribute to the literature on treatment of perfectionism, the effect of treating perfectionism on depression and anxiety, and the efficacy of Internet-based guided self-help interventions. CLINICALTRIAL:ClinicalTrials.gov NCT02756871; https://clinicaltrials.gov/ct2/show/NCT02756871 (Archived by WebCite at http://www.webcitation.org/6lmIlSRAa).

Project description:BackgroundIn patients with cardiovascular disease (CVD), knowledge about the associations among changes in depressive symptoms, self-efficacy, and self-care activities has been requested. This is because such knowledge can be helpful in the design of behavioral interventions aimed to improve self-efficacy, reduce depressive symptoms, and improve performance of self-care activities in CVD patients.ObjectiveWe aim to evaluate if internet-based cognitive behavioral therapy (iCBT) improves self-efficacy and explore the relationships among changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT on these relationships.MethodsThis study received funding in January 2015. Participant recruitment took place between January 2017 and February 2018, and the main findings were published in 2019. This study is a secondary analysis of data collected in a randomized controlled study evaluating the effects of a 9-week iCBT program compared to an online discussion forum (ODF) on depressive symptoms in patients with CVD (N=144). Data were collected at baseline and at the 9-week follow-up. Analysis of covariance was used to evaluate the differences in self-efficacy between the iCBT and ODF groups. Structural equation modeling explored the relationships among changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT on these relationships.ResultsAt follow-up, a significant difference in the increase in self-efficacy favoring iCBT was found (P=.04, Cohen d=0.27). We found an indirect association between changes in depressive symptoms and physical activity (β=-.24, P<.01), with the change in self-efficacy acting as a mediator. iCBT had a direct effect on the changes in depressive symptoms, which in turn influenced the changes in self-efficacy (β=.23, P<.001) and physical activity (β=.12, P<.001).ConclusionsSelf-efficacy was improved by iCBT. However, the influence of iCBT on self-efficacy and physical activity was mostly mediated by improvements in depressive symptoms.Trial registrationClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074.

Project description:BackgroundStudies have shown a high prevalence of depression during pregnancy, and there is also evidence that cognitive behavioral therapy (CBT) is one of the most effective psychosocial interventions. Emerging evidence from randomized controlled trials (RCTs) has shown that technology has been successfully harnessed to provide CBT interventions for other populations. However, very few studies have focused on their use during pregnancy. This approach has become increasingly important in many clinical areas due to the COVID-19 pandemic, and our study aimed to expand the knowledge in this particular clinical area.ObjectiveOur systematic review aimed to bring together the available research-based evidence on digitalized CBT interventions for depression symptoms during pregnancy.MethodsA systematic review of the Web of Science, Cochrane Central Register of Controlled Trials, CINAHL, MEDLINE, Embase, PsycINFO, Scopus, ClinicalTrials.gov, and EBSCO Open Dissertations databases was carried out from the earliest available evidence to October 27, 2021. Only RCT studies published in English were considered. The PRISMA (Preferred Reporting Items of Systematic Reviews and Meta-analyses) guidelines were followed, and the protocol was registered on the Prospective Register of Systematic Reviews. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials.ResultsThe review identified 7 studies from 5 countries (the United States, China, Australia, Norway, and Sweden) published from 2015 to 2021. The sample sizes ranged from 25 to 1342 participants. The interventions used various technological elements, including text, images, videos, games, interactive features, and peer group discussions. They comprised 2 guided and 5 unguided approaches. Using digitalized CBT interventions for depression during pregnancy showed promising efficacy, with guided intervention showing higher effect sizes (Hedges g=1.21) than the unguided interventions (Hedges g=0.14-0.99). The acceptability of the digitalized CBT interventions was highly encouraging, based on user feedback. Attrition rates were low for the guided intervention (4.5%) but high for the unguided interventions (22.1%-46.5%). A high overall risk of bias was present for 6 of the 7 studies.ConclusionsOur search only identified a small number of digitalized CBT interventions for pregnant women, despite the potential of this approach. These showed promising evidence when it came to efficacy and positive outcomes for depression symptoms, and user feedback was positive. However, the overall risk of bias suggests that the efficacy of the interventions needs to be interpreted with caution. Future studies need to consider how to mitigate these sources of biases. Digitalized CBT interventions can provide prompt, effective, evidence-based interventions for pregnant women. This review increases our understanding of the importance of digitalized interventions during pregnancy, including during the COVID-19 pandemic.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020216159; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=216159.

Dataset Information

The Generalizability of Randomized Controlled Trials of Self-Guided Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms: Systematic Review and Meta-Regression Analysis.

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The Generalizability of Randomized Controlled Trials of Self-Guided Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms: Systematic Review and Meta-Regression Analysis.

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