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An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: O'Connor K

PROVIDER: S-EPMC7414416 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial.

O'Connor Kathleen K Bagnell Alexa A McGrath Patrick P Wozney Lori L Radomski Ashley A Rosychuk Rhonda J RJ Curtis Sarah S Jabbour Mona M Fitzpatrick Eleanor E Johnson David W DW Ohinmaa Arto A Joyce Anthony A Newton Amanda A

JMIR mental health 20200724 7

<h4>Background</h4>Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.<h4>Objective</h4>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: Too ...[more]

PMID: 32706720

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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:BackgroundCaregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services.ObjectiveIn this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers.MethodsIn total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life.ResultsModerate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=-0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention's platform and the choice of content.ConclusionsThis is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life.Trial registrationClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724.

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: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.

Project description:BackgroundDepression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.

Project description:BackgroundDental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking.ObjectiveThis randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment.MethodsWe enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires.ResultsAll participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes-dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)-as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events.ConclusionsICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents.Trial registrationClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079.

Project description:ObjectivesObsessive-compulsive disorder (OCD) in childhood and adolescence often leads to significant impairment in various areas of life and has a high risk of becoming chronic. Cognitive behavioral therapy (CBT) is the recommended first-line treatment, but it is too rarely implemented in accordance with guidelines and is often not available close to the patient's home. Importantly, internet-based CBT could help to reduce this gap in care. Having previously successfully demonstrated the feasibility of an internet-based CBT approach, we aimed to assess its effectiveness in a waiting list controlled randomized trial.MethodsChildren and adolescents aged 6-18 years with a principal diagnosis of OCD received 14 sessions of therapist-delivered CBT via videoconference distributed over 16 weeks. After inclusion, participants were randomly assigned to either the treatment or waiting list group. Participants in the treatment group began treatment immediately after baseline diagnostics, and participants in the waiting list group began treatment after a 16-week waiting period. The primary outcome was a pre-post comparison of OCD symptoms as measured with the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Additionally, remission was an important outcome measure. Follow-up assessments were conducted for all measures 16 and 32 weeks after completion of treatment.ResultsA total of 60 children and adolescents were included into the analyses. Over the course of the treatment, OCD symptoms according to the CY-BOCS significantly decreased in the treatment group compared to the waiting-list control group. Cohen's d between groups was 1.63. After the patients in the waiting list group also received the treatment, the OCD symptoms decreased significantly in this group as well. This improvement of symptoms increased over the course of the follow-up assessments. Remission rate peaked at the 32-week follow-up, with 68% in the treatment group and 79% in the waiting list group. Importantly, patient satisfaction with treatment was high to very high.ConclusionIn our study, OCD symptoms decreased significantly and remission rate was high after internet-based CBT. Those effects were comparable to those found in studies of face-to-face treatment. Although further evidence is needed, these are early indications that our approach may be a viable way to provide access to adequate treatment for children and adolescents affected by OCD.Clinical trial registration[www.ClinicalTrials.gov], identifier [NCT05037344].

Dataset Information

An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial.

Publications

An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial.

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