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A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders.

ABSTRACT: BACKGROUND:Anxiety disorders are highly prevalent in adolescence, but access to health care services is limited and only few receive professional help. Internet-based cognitive behavioral therapy (ICBT) has been proposed to increase accessibility and reduce costs of treatment. OBJECTIVE:The study evaluated the efficacy of a Danish version of the guided ICBT program ChilledOut Online, developed at the Centre for Emotional Health, Macquarie University, Australia. METHOD:At the Centre for Psychological Treatment of Children and Adolescents, Aarhus University, Denmark, a randomized controlled trial was conducted with 70 adolescents (13-17 years) with anxiety disorders according to DSM-IV. Participants were randomly assigned to a 14-weeks therapist-guided ICBT or to a waitlist condition. Outcomes were evaluated post-treatment and at 3- and 12-month follow-up. RESULTS:At post-treatment, the ICBT group significantly outperformed the waitlist condition with moderate to large between-group effect sizes on diagnostic severity and anxiety symptoms rated by clinicians, and by adolescents and their parents. Forty percent of adolescents in ICBT were free of their primary diagnosis compared to 16% in the waitlist condition. Treatment gains were maintained at 3- and 12-month follow-up. CONCLUSION:Results of the study provide support for the efficacy of guided ICBT for adolescents with anxiety disorders. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02535403.

SUBMITTER: Stjerneklar S

PROVIDER: S-EPMC6750608 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders.

Stjerneklar Silke S Hougaard Esben E McLellan Lauren F LF Thastum Mikael M

PloS one 20190918 9

<h4>Background</h4>Anxiety disorders are highly prevalent in adolescence, but access to health care services is limited and only few receive professional help. Internet-based cognitive behavioral therapy (ICBT) has been proposed to increase accessibility and reduce costs of treatment.<h4>Objective</h4>The study evaluated the efficacy of a Danish version of the guided ICBT program ChilledOut Online, developed at the Centre for Emotional Health, Macquarie University, Australia.<h4>Method</h4>At th ...[more]

PMID: 31532802

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Project description:BACKGROUND:Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. OBJECTIVE:This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. METHODS:This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. RESULTS:Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. CONCLUSIONS:Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. TRIAL REGISTRATION:ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

Project description:BACKGROUND:Internet-based cognitive behavioral therapy (iCBT) increases treatment access for adolescents with anxiety; however, completion rates of iCBT programs are typically low. Understanding adolescents' experiences with iCBT, what program features and changes in anxiety (minimal clinically important difference [MCID]) are important to them, may help explain and improve iCBT program use and impact. OBJECTIVE:Within a randomized controlled trial comparing a six-session iCBT program for adolescent anxiety, Being Real, Easing Anxiety: Tools Helping Electronically (Breathe), with anxiety-based resource webpages, we aimed to (1) describe intervention use among adolescents allocated to Breathe or webpages and those who completed postintervention assessments (Breathe or webpage respondents); (2) describe and compare user experiences between groups; and (3) calculate an MCID for anxiety and explore relationships between iCBT use, experiences, and treatment response among Breathe respondents. METHODS:Enrolled adolescents with self-reported anxiety, aged 13 to 19 years, were randomly allocated to Breathe or webpages. Self-reported demographics and anxiety symptoms (Multidimensional Anxiety Scale for Children-2nd edition [MASC-2]) were collected preintervention. Automatically-captured Breathe or webpage use and self-reported symptoms and experiences (User Experience Questionnaire for Internet-based Interventions) were collected postintervention. Breathe respondents also reported their perceived change in anxiety (Global Rating of Change Scale [GRCS]) following program use. Descriptive statistics summarized usage and experience outcomes, and independent samples t tests and correlations examined relationships between them. The MCID was calculated using the mean MASC-2 change score among Breathe respondents reporting somewhat better anxiety on the GRCS. RESULTS:Adolescents were mostly female (382/536, 71.3%), aged 16.6 years (SD 1.7), with very elevated anxiety (mean 92.2, SD 18.1). Intervention use was low for adolescents allocated to Breathe (mean 2.2 sessions, SD 2.3; n=258) or webpages (mean 2.1 visits, SD 2.7; n=278), but was higher for Breathe (median 6.0, range 1-6; 81/258) and webpage respondents (median 2.0, range 1-9; 148/278). Total user experience was significantly more positive for Breathe than webpage respondents (P<.001). Breathe respondents reported program design and delivery factors that may have challenged (eg, time constraints and program support) or facilitated (eg, demonstration videos, self-management activities) program use. The MCID was a mean MASC-2 change score of 13.8 (SD 18.1). Using the MCID, a positive treatment response was generated for 43% (35/81) of Breathe respondents. Treatment response was not correlated with respondents' experiences or use of Breathe (P=.32 to P=.88). CONCLUSIONS:Respondents reported positive experiences and changes in their anxiety with Breathe; however, their reports were not correlated with program use. Breathe respondents identified program design and delivery factors that help explain their experiences and use of iCBT and inform program improvements. Future studies can apply our measures to compare user experiences between internet-based interventions, interpret treatment outcomes and improve treatment decision making for adolescents with anxiety. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02970734 https://clinicaltrials.gov/ct2/show/NCT02970734.

Project description:BackgroundAnxiety disorders affect a quarter of the population during their lifetime, and typically emerge in childhood or adolescence. Anxiety disorders disrupt young people's social, emotional and academic development and in the absence of treatment, often follow a chronic course. Although effective treatments, such as Cognitive Behaviour Therapy (CBT), exist, only a small proportion of adolescents with anxiety disorders who need treatment receive them. Barriers to treatment provision include the fact that CBT typically requires 14-16 sessions by a highly qualified therapist and services are stretched - resulting in lengthy waiting lists and limited access to treatment. This highlights the importance of developing new ways of providing effective treatments for adolescent anxiety disorders. This study aims to assess the feasibility of a future, large-scale trial. This will give a clear indication of the likely success of running a randomised controlled trial to compare a new, brief cognitive therapy treatment to an existing CBT group therapy for adolescents with anxiety disorders.Methods/designThe study will examine whether a definitive trial can be conducted on the basis of a feasibility RCT using a number of well-defined criteria. The feasibility RCT is a single-centre, randomised control trial. Forty-eight Young people (age 11-17.5 years) attending a university research clinic, who meet the diagnostic criteria for a DSM-5 anxiety disorder, will be randomly allocated to receive either (1) Adolescent Cognitive Therapy for Anxiety (ACTA), which involves six 60-90-min sessions and a booster session or (2) group CBT, which involves eight 2-h sessions and a booster session. As part of the feasibility indicators, patient outcomes, expectations and experiences, as well as health economic factors, will be assessed before, at the end of treatment and at a 3-month follow-up.DiscussionThe successful delivery of a future, definitive trial has the potential to bring direct benefits to young people and their families, adolescent mental health service providers, as well as benefits to adult mental health services and society more broadly by disrupting the negative trajectory commonly associated with adolescent anxiety disorders.Trial registrationISRCTN, ID: ISRCTN86123204 . Retrospectively registered on 23 November 2017.

Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.

Project description:BackgroundAmple studies have shown the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) for anxiety disorders. These studies recruited their participants mainly from the community and, to a lesser extent, from within routine care services. Little is known about whether different recruitment strategies lead to different treatment effects.ObjectiveThis meta-analysis compared clinical results obtained in trials with recruitment from the community versus results obtained in trials with clinical service recruitment and explored factors that may mediate differences in treatment outcome.MethodsWe included randomized controlled trials in which the clinical effects of iCBT for anxiety disorders were compared with a control condition (waitlist controls or face-to-face cognitive behavioral therapy). We classified trials as open recruitment trials (recruitment from the community) or clinical service recruitment trials (recruitment through outpatient clinics). Pooled effect sizes based on measures examining anxiety symptoms, depressive symptoms, and quality of life were computed for each type of trial. Subgroup analyses examined whether clinical results from open recruitment trials differed from those obtained in clinical service recruitment trials. Additional analyses explored which demographic, clinical, and treatment-related factors contributed to differences in effect sizes of open recruitment versus clinical service recruitment trials.ResultsWe included 42 studies with 53 comparisons (43 open recruitment comparisons and 10 clinical recruitment comparisons). Analyses of anxiety measures revealed, first, that iCBT open recruitment studies with waitlist control comparators showed a significantly higher effect size for decrease in anxiety symptoms than did those with clinical recruitment (Q=10.09; P=.001). This association between recruitment method and effect size was no longer significant in a multivariate metaregression with treatment adherence and exclusion of patients with depressive symptoms entered as additional predictors of effect size. Second, effect size for decrease in anxiety symptoms did not differ significantly between clinical recruitment and open recruitment studies with face-to-face cognitive behavioral therapy comparators. The effects of open recruitment trials and clinical recruitment trials did not differ significantly for the secondary outcomes, compared with face-to-face cognitive behavioral therapy and waitlist controls.ConclusionsiCBT was effective in samples recruited in clinical practice, but effect sizes were smaller than those found in trials with an open recruitment method for studies with waitlist control comparators. Hence, for patients with anxiety disorders in routine care, the impact of iCBT may not be as positive as for study participants recruited from the community. The difference between open recruitment trials and clinical service recruitment trials might be partly explained by patients' greater therapy adherence in open recruitment trials and the stricter exclusion of patients with severe depressive symptoms in these studies. Since most trials in this meta-analysis applied an open recruitment method, more studies with routine care populations are needed to further validate these findings.

Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is the gold standard treatment for adult anxiety disorders but is often not readily available in a scalable manner in many clinical settings. OBJECTIVE:This study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care. METHODS:In an open trial, patients who screened positive for anxiety (General Anxiety Disorder-7 [GAD7] score ?5) were offered the digital cognitive behavioral program (active group, n=593). Primary outcomes included anxiety, quality of life (QoL), and ambulatory medical use over 6 months. Intent-to-treat (ITT) and modified intent-to-treat (mITT) analyses were completed. Subsequently, we compared the outcomes of participants with those of a matched control group receiving primary care as usual (CAU; n=316). RESULTS:More than half of the patients downloaded the cognitive behavioral mobile app program and about 60% of these were considered engaged, which was defined as completion of ?3 techniques. The active group demonstrated medium size effects on reducing anxiety symptoms (effect size d=0.44; P<.001) and improving mental health QoL (d=0.49; P<.001) and showed significantly improved physical health QoL (d=0.39; P=.002) and a decreased likelihood of high utilization of outpatient medical care (odds ratio=0.49; P<.001). The active group did not significantly outperform the CAU group in anxiety reduction or QoL improvement (d=0.20; P=.07). However, intent-to-treat analysis showed that the active group had a significantly lower likelihood of high utilization of outpatient medical care than the enhanced CAU group (P<.0001; odds ratio=0.09). CONCLUSIONS:A coach-facilitated digital cognitive behavioral program prescribed in primary care is feasible and acceptable. Primary care patients prescribed a digital cognitive behavioral program for anxiety experienced significant improvements in anxiety symptoms, QoL, and reduced medical utilization. This effect was observed even among patients with chronic medical conditions and behavioral health comorbidities. Although the primary outcomes in the active group did not improve significantly more than the CAU group, health care utilization declined, and some secondary outcomes improved in participants who engaged in the program compared to the CAU group. TRIAL REGISTRATION:ClinicalTrials.gov NCT03186872; https://clinicaltrials.gov/ct2/show/NCT03186872.

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A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders.

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A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders.

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