Sampling bias in an internet treatment trial for depression.
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ABSTRACT:
SUBMITTER: Donkin L
PROVIDER: S-EPMC3565809 | biostudies-other | 2012
REPOSITORIES: biostudies-other
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Project description:ObjectiveComputerized cognitive-bias modification (CBM) protocols are rapidly evolving in experimental medicine yet might best be combined with Internet-based cognitive behavioral therapy (iCBT). No research to date has evaluated the combined approach in depression. The current randomized controlled trial aimed to evaluate both the independent effects of a CBM protocol targeting imagery and interpretation bias (CBM-I) and the combined effects of CBM-I followed by iCBT.MethodPatients diagnosed with a major depressive episode were randomized to an 11-week intervention (1 week/CBM-I + 10 weeks/iCBT; n = 38) that was delivered via the Internet with no face-to-face patient contact or to a wait-list control (WLC; n = 31).ResultsIntent-to-treat marginal models using restricted maximum likelihood estimation demonstrated significant reductions in primary measures of depressive symptoms and distress corresponding to medium-large effect sizes (Cohen's d = 0.62-2.40) following CBM-I and the combined (CBM-I + iCBT) intervention. Analyses demonstrated that the change in interpretation bias at least partially mediated the reduction in depression symptoms following CBM-I. Treatment superiority over the WLC was also evident on all outcome measures at both time points (Hedges gs = .59-.98). Significant reductions were also observed following the combined intervention on secondary measures associated with depression: disability, anxiety, and repetitive negative thinking (Cohen's d = 1.51-2.23). Twenty-seven percent of patients evidenced clinically significant change following CBM-I, and this proportion increased to 65% following the combined intervention.ConclusionsThe current study provides encouraging results of the integration of Internet-based technologies into an efficacious and acceptable form of treatment delivery. (PsycINFO Database Record (c) 2013 APA, all rights reserved).
| S-EPMC3780629 | biostudies-literature
Project description:BackgroundInternet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided.QuestionWould guidance from a technician be as effective as guidance from a clinician?MethodRandomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program.ConclusionsBoth clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12609000559213.
| S-EPMC2882336 | biostudies-literature
Project description:Theoretical models and empirical research point to negatively biased attention as a maintaining factor in depression. Although preliminary studies suggest experimentally modifying attentional biases (i.e., attentional bias modification; ABM) reduces depression symptoms and depression risk, relatively few rigorous studies with clinical samples have been completed. This clinical trial examines the impact of ABM on a sample of adults (N?=?123) with elevated depression severity who also exhibit at least modest levels of negatively biased attention prior to treatment. Participants will be randomly assigned to either active ABM, placebo ABM, or an assessment-only control condition. Individuals assigned to ABM will complete 5 trainings per week (2 in-clinic, 3 brief trainings at-home) during a four-week period. Throughout this four-week period, participants will complete weekly assessments of symptom severity and putative treatment mediators measured across different levels of analysis (e.g., eye tracking, behavioral measures, and functional Magnetic Resonance Imaging). This article details the rationale and design of the clinical trial, including methodological issues that required more extensive consideration. Our findings may not only point to an easily-accessible, efficacious treatment for depression but may also provide a meaningful test of whether a theoretically important construct, negatively biased attention, maintains depression.
| S-EPMC6431548 | biostudies-literature
Project description:Study objectivesTo compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression.DesignA 9-w randomized controlled trial with 6- and 12-mo follow-up.SettingInternet Psychiatry Clinic, Stockholm, Sweden.ParticipantsForty-three adults in whom comorbid insomnia and depression were diagnosed, recruited via media and assessed by psychiatrists.InterventionsGuided Internet-delivered cognitive behavior therapy (ICBT) for either insomnia or depression.Measurements and resultsPrimary outcome measures were symptom self-rating scales (Insomnia Severity Index [ISI] and the Montgomery Åsberg Depression Rating Scale [MADRS-S]), assessed before and after treatment with follow-up after 6 and 12 mo. The participants' use of sleep medication and need for further treatment after completion of ICBT was also investigated. The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment (P = 0.05), and equally effective in reducing depression severity. Group differences in insomnia severity were maintained during the 12-mo follow-up period. Post treatment, participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment (P < 0.001) and used less sleep medication (P < 0.05) than participants receiving treatment for depression. The need for depression treatment was similar in both groups.ConclusionsIn this study, Internet-delivered treatment with cognitive behavior therapy (ICBT) for insomnia was more effective than ICBT for depression for patients with both diagnoses. This indicates, in line with previous research, that insomnia when comorbid with depression is not merely a symptom of depression, but needs specific treatment.Trial registrationThe trial was registered at Clinicaltrials.gov, registration ID: NCT01256099.
| S-EPMC4288608 | biostudies-literature
Project description:BackgroundDepression is a major contributor to the burden of disease in the adolescent population. Internet-based interventions can increase access to treatment.AimsTo evaluate the efficacy of internet-based cognitive-behavioural therapy (iCBT), including therapist chat communication, in treatment of adolescent depression.MethodSeventy adolescents, 15-19 years of age and presenting with depressive symptoms, were randomised to iCBT or attention control. The primary outcome was the Beck Depression Inventory II (BDI-II).ResultsSignificant reductions in depressive symptoms were found, favouring iCBT over the control condition (F(1,67) = 6.18, P < 0.05). The between-group effect size was Cohen's d = 0.71 (95% CI 0.22-1.19). A significantly higher proportion of iCBT participants (42.4%) than controls (13.5%) showed a 50% decrease in BDI-II score post-treatment (P < 0.01). The improvement for the iCBT group was maintained at 6 months.ConclusionsThe intervention appears to effectively reduce symptoms of depression in adolescents and may be helpful in overcoming barriers to care among young people.Declaration of interestN.T. and G.A. designed the programme. N.T. authored the treatment material. The web platform used for treatment is owned by Linköping University and run on a non-for-profit basis. None of the authors receives any income from the programme.
| S-EPMC6034465 | biostudies-literature
Project description:BackgroundInternet-based interventions promise to enhance the accessibility of mental health care for a greater number of people and in more remote places. Their effectiveness has been shown for the prevention and treatment of various mental disorders. However, their potential when delivered as add-on to conventional treatment (ie, blended care) is less clear.ObjectiveThe aim of this study is to study the effectiveness of an internet intervention (ASCENSO) implemented in addition to face-to-face treatment as usual (TAU) for depression.MethodsA 2-arm, parallel-group, randomized controlled trial was conducted in an outpatient private mental health care center in Chile. In all, 167 adults, diagnosed with major depressive disorder, without severe comorbidities, and with internet access, were included. Eighty-four participants were assigned to the intervention group and received medical and psychological TAU from the mental health center plus access to the ASCENSO online platform. The control group (n=83) received only TAU. The ASCENSO platform includes psycho-educational information, depressive symptom monitoring and feedback, and managing emergencies based on the principles of cognitive behavioral therapy. Emergency management was mental health provider-assisted. TAU includes access to primary care physicians and psychiatrists, to a brief individual psychotherapy, and to medication when needed. The baseline questionnaires were administered in person, and 6- and 9-months assessments were conducted online. Depression symptoms and quality of life were measured by self-administered questionnaires, and treatment adherence was determined via the Mental Health Center's internal records. The usage of ASCENSO was assessed by server logs. Reduction on depressive symptomatology was considered as the primary outcome of the intervention and quality of life as a secondary outcome.ResultsOf the 84 participants in the intervention group, 5 participants (6%) never accessed the online platform. Of the remaining 79 participants who accessed ASCENSO, 1 (1%, 1/79) did not answer any of the symptom questionnaire, and most participants (72/79, 91%) answered the monitoring questionnaires irregularly. The ASCENSO intervention implemented in addition to face-to-face care did not improve the outcome of the usual care delivered at the mental health center, either in terms of reduction of depressive symptoms (F2,6087= 0.48; P=.62) or in the improvement of quality of life (EQ-5D-3L: F2,7678=0.24; P=.79 and EQ-VAS: F2,6670= 0.13; P=.88). In contrast, for the primary (F2,850=78.25; P<.001) and secondary outcomes (EQ-5D-3L: F2,1067=37.87; EQ-VAS: F2,4390= 51.69; P<.001) in both groups, there was an improvement from baseline to 6 months (P<.001), but there was no change at 9 months. In addition, no effects on adherence to or use of TAU were found. Finally, the dropout rate for the face-to-face treatment component was 54% (45/84) for the intervention group versus 39% (32/83) for the control group (P=.07).ConclusionsThe fact that the adjunctive access to ASCENSO did not improve outcome could be due to both the rather high effectiveness of TAU and to patients' limited use of the online platform.Trial registrationClinicalTrials.gov NCT03093467; https://clinicaltrials.gov/ct2/show/NCT03093467.
| S-EPMC8726028 | biostudies-literature
Project description:BackgroundStudies on guided internet-delivered treatment have demonstrated promising results for patients with depressive disorder.ObjectiveThe aim of this study was to provide an overview of this research area and identify potential gaps in the research.MethodsIn this scoping review, web-based databases were used to identify research papers published between 2010 and 2022 where guided internet-delivered treatment was administered to participants with depressive disorders, a standardized rating scale of depressive symptoms was used as the primary outcome measure, and the treatment was compared with a control condition.ResultsA total of 111 studies were included, and an overview of the studies was provided. Several gaps in the research were identified regarding the design of the studies, treatments delivered, participant representation, and treatment completion.ConclusionsThis review provides a comprehensive overview of the research area, and several research gaps were identified. The use of other designs and active control conditions is recommended. Future studies should provide access to treatment manuals, and more replications should be conducted. Researchers should aim to include underrepresented populations and provide reports of comorbidities. Definitions of adequate dosage, reports of completion rates, and reasons for treatment dropout are recommended for future studies.
| S-EPMC9579933 | biostudies-literature
Project description:Aim:To examine the efficacy of transdiagnostic internet-delivered cognitive behavioural therapy (iCBT), mindfulness-enhanced iCBT, and stand-alone online mindfulness training compared with a usual care control group (TAU) for clinical anxiety and depression. Method:Individuals (N = 158) with a DSM-5 diagnosis of a depressive and/or anxiety disorder were randomised to one of the three clinician-guided online interventions, or TAU over a 14-week intervention period. The primary outcomes were self-reported depression (PHQ-9) and anxiety (GAD-7) severity at post-treatment. Secondary outcomes included adherence rates, functional impairment (WHODAS-II), general distress (K-10), and diagnostic status at the 3-month follow-up (intervention groups). Results:All three programs achieved significant and large reductions in symptoms of depression (g = 0.89-1.53), anxiety (g = 1.04-1.40), and distress (g = 1.25-1.76); and medium to large reductions in functional impairment (g = 0.53-0.98) from baseline to post-treatment and 3-month follow-up. Intention-to-treat linear mixed models showed that all three online programs were superior to usual care at reducing symptoms of depression (g = 0.89-1.18) and anxiety (g = 1.00-1.23). Conclusion:Transdiagnostic iCBT, mindfulness-enhanced iCBT and online mindfulness training are more efficacious for treating depression and anxiety disorders than usual care, and represent an accessible treatment option for these disorders.
| S-EPMC7044661 | biostudies-literature
Project description:BackgroundDepression and anxiety are common, disabling and chronic. Self-guided internet-delivered treatments are popular, but few people complete them. New strategies are required to realise their potential.AimsTo evaluate the effect of automated emails on the effectiveness, safety, and acceptability of a new automated transdiagnostic self-guided internet-delivered treatment, the Wellbeing Course, for people with depression and anxiety.MethodA randomised controlled trial was conducted through the website: www.ecentreclinic.org. Two hundred and fifty seven people with elevated symptoms were randomly allocated to the 8 week course either with or without automated emails, or to a waitlist control group. Primary outcome measures were the Patient Health Questionnaire 9-Item (PHQ-9) and the Generalized Anxiety Disorder 7-Item (GAD-7).ResultsParticipants in the treatment groups had lower PHQ-9 and GAD-7 scores at post-treatment than controls. Automated emails increased rates of course completion (58% vs. 35%), and improved outcomes in a subsample with elevated symptoms.ConclusionsThe new self-guided course was beneficial, and automated emails facilitated outcomes. Further attention to strategies that facilitate adherence, learning, and safety will help realise the potential of self-guided interventions.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610001058066.
| S-EPMC3701078 | biostudies-literature
Project description:In-person lifestyle interventions for obesity treatment yield significant improvements in depression. These improvements may be attributed to the excellent weight losses produced by in-person interventions. In contrast, Internet programs yield more modest weight losses, and their effect on depression is unknown. This study is the first to examine whether Internet-delivered obesity treatment impacts depressive symptoms.Participants (N = 136) were randomized to either a community campaign plus Internet behavioral weight loss (IBWL) or community campaign alone (Control). IBWL did not include online social support components. A measure of depressive symptoms was administered, and weight was objectively assessed.Of the total sample, 24% met the clinical cutoff for elevated depression risk at baseline. IBWL participants lost more weight during treatment (P = 0.005) and experienced significantly greater improvements in depressive symptoms (P = 0.02). Among participants who met the clinical cutoff for elevated risk for depression at baseline, those assigned to IBWL had greater improvements in depressive symptoms during treatment compared to Control (P = 0.033). Consequently, at post-treatment, a smaller percentage of IBWL participants were at elevated risk for depression.This study is the first to show that Internet-delivered obesity treatment improves depression risk and depressive symptoms in individuals with overweight or obesity.
| S-EPMC5373949 | biostudies-other