Randomized effectiveness trial of an Internet, pure self-help, cognitive behavioral intervention for depressive symptoms in young adults.
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ABSTRACT:
SUBMITTER: Clarke G
PROVIDER: S-EPMC2829099 | biostudies-literature | 2009
REPOSITORIES: biostudies-literature
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Randomized effectiveness trial of an Internet, pure self-help, cognitive behavioral intervention for depressive symptoms in young adults.
Clarke Greg G Kelleher Chris C Hornbrook Matt M Debar Lynn L Dickerson John J Gullion Christina C
Cognitive behaviour therapy 20090101 4
This study evaluated an Internet-delivered, cognitive behavioral skills training program versus a treatment-as-usual (TAU) control condition targeting depression symptoms in young adults aged 18 to 24 years. Potential participants were mailed a recruitment brochure; if interested, they accessed the study website to complete an online consent and baseline assessment. Intervention participants could access the website at their own pace and at any time. Reminder postcards were mailed periodically t ...[more]
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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.
| S-EPMC7055858 | biostudies-literature
Project description:Traditionally, evidence-based treatments for depression have focused on negative symptoms. Different authors describe the need to include positive affect as a major target of treatment. Positive psychology aims to fill this gap. Reaching everyone in need is also important, and Internet-based interventions can help in this task. The present study is a secondary analysis derived from a randomized controlled trial aimed to test the efficacy of an Internet-based intervention for patients with depressive symptoms. This intervention consisted of an 8-module Internet-based program that combined four modules based on cognitive-behavioral therapy strategies and four modules based on positive psychology strategies. The main goal of this secondary analysis is to report the data collected after each module from the participants who completed the intervention, explore the changes throughout the intervention process, and examine the changes observed in the different variables before versus after the introduction of the positive psychology component. A total of 103 patients completed the intervention. At pre-, post-intervention, and post-module evaluations, they completed positive and negative affect, depression, and anxiety measures. Negative affect and anxiety decreased significantly during the implementation of the cognitive-behavioral therapy and positive psychology modules. However, depression and positive affect improved only after the introduction of the positive psychology modules. This is the first study to explore, throughout the intervention process (module by module), the incorporation of a positive psychology component in an Internet-based program. Results suggest that positive psychology techniques might have an impact on clinical symptomatology, and they emphasize the need to include these techniques to achieve a more profound change in positive functioning measures. Clinical Trial Registration: NCT02148354 (http://ClinicalTrials.gov/ct2/show/NCT02148354).
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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).
| S-EPMC5124110 | biostudies-literature
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:BackgroundLittle empirical evidence is available to support the effectiveness and cost-effectiveness of internet interventions to increase help-seeking behavior for mental health in young adults.ObjectiveThe aim of this study was to evaluate the cost-effectiveness of a Web-based mental health help-seeking navigation tool (Link) in comparison with usual help-seeking strategies.MethodsA cost-utility analysis alongside the main randomized trial of Link was conducted from the Australian health care sector perspective. Young adults aged 18 to 25 years were randomized to the Link intervention (n=205) or usual care (n=208) with 1- and 3-month follow-ups. The primary outcome of this study was quality-adjusted life years (QALYs) measured by the assessment of quality of life-4D. Costs were calculated based on the self-reported resource use questionnaire and were reported in 2015 Australian dollars. Primary analyses were conducted as intention-to-treat and reported as incremental cost-effectiveness ratios. Completer analyses were conducted in a sensitivity analysis.ResultsSignificantly more QALYs were gained in the intervention group than the control group (0.15 vs 0.14; P<.001). The intervention was associated with significantly lower health professional consultation costs at 1-month follow-up (mean costs Aus $98 vs Aus $162; P<.05). Costs of hospital services were lower at 3 months in the intervention arm (mean costs Aus $47 vs Aus $101); however, there was insufficient sample size to detect a significant difference between the groups. There were no statistically significant differences in the total costs between the 2 arms. Relative to the control group, those who received the intervention experienced 0.01 more QALYs (0.00-0.02) and had lower total health sector costs of Aus -$81 (Aus -$348 to Aus $186) over 3 months. The intervention was found to be more effective and less costly compared with usual help-seeking strategies. The intervention was 100% likely to be cost-effective below a willingness-to-pay value-for-money threshold of Aus $28,033 per QALY. Results were robust in the sensitivity analysis.ConclusionsOur study found that the online youth mental health help-seeking Web service is a cost-effective intervention for young people aged 18 to 25 years compared with usual search strategies. Further research is required to confirm these results.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001223628; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=366731.
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Project description:Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].
| S-EPMC3515424 | biostudies-literature
Project description:IntroductionDepression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting.Methods and analysisThis study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants' all-cause sickness absence as indicated in employer's and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer's records. Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationThe Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience.Trial registration numberISRCTN10877837.
| S-EPMC6858165 | biostudies-literature
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.
| S-EPMC8908191 | biostudies-literature
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.
| S-EPMC8150403 | 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.
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