A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders.
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ABSTRACT:
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]
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Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.ObjectiveThis 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.MethodsThis 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.ResultsOf 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.ConclusionsAdolescents 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 registrationClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.
| S-EPMC7414416 | biostudies-literature
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.
| S-EPMC7055748 | biostudies-literature
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.
| S-EPMC6485105 | biostudies-literature
Project description:Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed.
| S-EPMC4272761 | biostudies-literature
Project description:Computerized treatments have been shown to be effective in young people with anxiety disorders. However, there has been limited investigation into the experiences of adolescents in undertaking this treatment. This qualitative study explored adolescents’ experiences of being treated for an anxiety disorder, using an online intervention with therapist support, as part of a randomised controlled trial. Individual semi-structured interviews were conducted with thirteen adolescents aged between 13 and 17 years, who had received the online intervention. Data were analysed using reflexive thematic analysis. Two cross-cutting themes were identified: (i) Usability of the program, and (ii) Putting techniques into practice. Although the convenience of online sessions was recognised as positive, many of the adolescents expressed a preference for face-to-face sessions. The length of sessions and the large amount of reading involved was highlighted by most participants. The transdiagnostic nature of the content meant some elements of the programme were seen as less relevant. While many participants appreciated the ‘fun’ aspect of the program, others felt that certain aspects of the program were not suitable for their age group. Exposure, psychoeducation and cognitive restructuring were generally received positively, whereas responses to the use of relaxation and rewards were much more mixed. Our findings highlight the potential utility for online treatments delivered with therapist support. However, they also highlight how issues with both the format and treatment components can impact the acceptability of a program. As such, further work is warranted to improve the acceptability of online treatments for adolescents with anxiety disorders. Supplementary Information The online version contains supplementary material available at 10.1007/s00787-021-01903-6.
| S-EPMC8572655 | biostudies-literature
Project description:BackgroundSocial anxiety disorder (SAD) is a common mental disorder in adolescents and young adults. Early intervention and support could help prevent the development of full-blown SAD. Considering that adolescents with social anxiety symptoms do not prefer face-to-face sessions due to their fear of communicating with therapists, internet-based cognitive behavioral therapy (ICBT) was implemented.ObjectiveThis study aimed to examine the effectiveness of complete self-help ICBT for subthreshold SAD in high school and college students with no history of mental disorders.MethodsA multicenter randomized controlled trial designed to demonstrate the objective was conducted from December 2022 to October 2023. Participants were students enrolled at 6 universities and 1 high school. The intervention was a complete self-help ICBT and consisted of 10 text-based sessions that taught cognitive behavioral therapy techniques for social anxiety in youths and young adults. The comparison was a no-treatment condition (control group), which was randomly assigned in a 1:1 ratio by a computer program. A total of 2 psychological scales were used to assess the severity of social anxiety, and 1 psychological scale each was used to measure symptoms of depression, general anxiety, and quality of life.ResultsIn total, 77 students were enrolled as study participants. Through the randomization procedure, 38 participants were included in the intervention group, and 39 patients were included in the control group. Results from the analysis of covariance with depression as covariates showed that the participants in the intervention group had significantly reduced symptoms of social anxiety, depression, and general anxiety compared to the control group. The response rate was 61% (19/31) in the intervention group and 24% (9/38) in the control group: odds ratio (OR) 4.97 (95% CI 1.61-16.53; P=.003) in the Fisher exact test. The recovery rate was 68% (21/31) in the intervention group and 34% (13/38) in the control group: OR 3.95 (95% CI 1.32-12.56; P=.008). The OR for the remission ratio was 2.01 (95% CI 0.64-6.60; P=.20) and for the risk of worsening was 0.23 (95% CI 0.002-1.33; P=.10), but no significant difference was observed.ConclusionsThe results of this randomized controlled trial show that fully unguided ICBT improves subthreshold SAD in adolescents and young adults. Interpretation of the effectiveness in preventing SAD that meets the diagnostic criteria is limited by sample size and the follow-up period. Future studies should include more extended observations and larger sample sizes in high-risk populations.Trial registrationUMIN-CTR UMIN000050064; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057035.
| S-EPMC11301114 | biostudies-literature
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.
| S-EPMC4418823 | biostudies-literature
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.
| S-EPMC6492068 | biostudies-literature
Project description:Examine the efficacy of a personalized, modular cognitive-behavioral therapy (CBT) protocol among early adolescents with high-functioning autism spectrum disorders (ASDs) and co-occurring anxiety relative to treatment as usual (TAU).Thirty-one children (11-16 years) with ASD and clinically significant anxiety were randomly assigned to receive 16 weekly CBT sessions or an equivalent duration of TAU. Participants were assessed by blinded raters at screening, posttreatment, and 1-month follow-up.Youth randomized to CBT demonstrated superior improvement across primary outcomes relative to those receiving TAU. Eleven of 16 adolescents randomized to CBT were treatment responders, versus 4 of 15 in the TAU condition. Gains were maintained at 1-month follow-up for CBT responders.These data extend findings of the promising effects of CBT in anxious youth with ASD to early adolescents.
| S-EPMC4346416 | biostudies-literature
Project description:BackgroundCognitive 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.ObjectiveThis study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care.MethodsIn 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).ResultsMore 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).ConclusionsA 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 registrationClinicalTrials.gov NCT03186872; https://clinicaltrials.gov/ct2/show/NCT03186872.
| S-EPMC6470461 | biostudies-literature