Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Chun HY
PROVIDER: S-EPMC7382539 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
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Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial.
Chun Ho-Yan Yvonne HY Carson Alan J AJ Tsanas Athanasios A Dennis Martin S MS Mead Gillian E GE Calabria Clementina C Whiteley William N WN
Stroke 20200624 8
<h4>Background and purpose</h4>Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a randomized controlled trial workflow that enabled all trial procedures to be carried out remotely. In addition, we explored the feasibility of wrist-worn actigraphy sensor as a way of meas ...[more]
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Project description:Dental anxiety affects approximately 9% of children and is associated with poor oral health, pain, and psychosocial problems. The objective of this study was to investigate the efficacy of cognitive behavioral therapy (CBT) for children with dental anxiety in specialist pediatric dentistry. The study used a parallel-group superiority randomized controlled trial design. The primary outcome measure was the behavioral avoidance test; assessors were blind to treatment allocation. Participants were 8 boys and 22 girls 7 to 18 y old (mean ± SD, 10 ± 3.1). Children fulfilling the diagnostic criteria for dental anxiety were randomized to CBT (n = 13) or treatment as usual (n = 17), such as various sedation methods. Psychologists provided 10 h of CBT based on a treatment manual. Treatments were conducted in a naturalistic real-world clinical setting. Assessments were conducted before the treatment, 3 mo after the start of treatment, and at 1-y follow-up. The analyses of the primary outcome measure by repeated-measures analysis of variance and independent t test showed that children receiving CBT made superior, statistically significant improvements at follow-up (16.8 ± 2.4) compared with treatment as usual (11.4 ± 3.1, P < 0.01). A large between-group effect size (Cohen's d = 1.9) was found. Following treatment, 73% of those in the CBT group managed all stages of the dental procedures included in the behavioral avoidance test compared with 13% in the treatment-as-usual group. Furthermore, 91% in the CBT group compared with 25% in the treatment-as-usual group no longer met the diagnostic criteria for dental anxiety at the 1-y follow-up according to the secondary outcome measure. Measures of dental anxiety and self-efficacy showed larger improvements in the CBT group compared with controls. We conclude that CBT is an efficacious treatment for children and adolescents with dental anxiety and should be made accessible in pediatric dentistry (ClinicalTrials.gov: NCT01798355). Knowledge transfer statement: The results of this study can be used by decision makers and clinicians when planning to implement evidence-based treatment in pediatric dentistry and give children and adolescents access to methods for treating dental anxiety. The results can also be used by parents of children with dental anxiety when asking dentists to cooperate with psychologists using cognitive behavioral therapy.
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Project description:BackgroundEmotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Virtual reality-assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently lacks cultural sensitivity and can be improved by adapting it to the cultural context of service users. During previous participatory research, we co-designed a culturally adapted cognitive behavioral therapy (CBT) manual and 2 virtual reality (VR) environments to function as a complement to therapy (VR-CBT) for Inuit who would like to access psychotherapy. Emotion regulation skill building will occur in virtual environments that have interactive components such as heart rate biofeedback.ObjectiveWe describe a protocol for a proof-of-concept 2-arm randomized controlled trial (RCT) with Inuit (n=40) in Québec. The primary aims of this research are to investigate the feasibility, benefits, and challenges of the culturally adapted VR-CBT intervention versus an established VR self-management that is available commercially. We will also investigate self-rated mental well-being and objective psychophysiological measures. Finally, we will use proof-of-concept data to identify suitable primary outcome measures, conduct power calculations in a larger trial for efficacy, and collect information about preferences for on-site or at-home treatment.MethodsTrial participants will be randomly assigned to an active condition or active control condition in a 1:1 ratio. Inuit aged 14 to 60 years will receive a culturally adapted and therapist-guided VR-CBT with biofeedback or a VR relaxation program with nonpersonalized guided components over a 10-week period. We will collect pre- and posttreatment measures of emotion regulation and biweekly assessments over the treatment and at 3-month follow-up. The primary outcome will be measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and well-being via rating scales (eg, anxiety or depressive symptoms).ResultsAs this is the prospective registration of an RCT protocol, we do not yet report any results from the trial. Funding was confirmed in January 2020, and recruitment is expected to start in March 2023 and is set to finish in August 2025. The expected results are to be published in spring 2026.ConclusionsThe proposed study responds to the community's desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Québec. We will test feasibility and acceptance by comparing a culturally adapted, on-site psychotherapy with a commercial self-management program while incorporating novel technology and measurement in the area of Indigenous health. We also aim to fulfill the needs for RCT evidence of culturally adapted psychotherapies that are lacking in Canada.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 21831510; https://www.isrctn.com/ISRCTN21831510.International registered report identifier (irrid)PRR1-10.2196/40236.
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Project description:BackgroundChildren with autism spectrum disorders often present with comorbid anxiety disorders that cause significant functional impairment. This study tested a modular cognitive behavioral therapy (CBT) program for children with this profile. A standard CBT program was augmented with multiple treatment components designed to accommodate or remediate the social and adaptive skill deficits of children with ASD that could pose barriers to anxiety reduction.MethodForty children (7-11 years old) were randomly assigned to 16 sessions of CBT or a 3-month waitlist (36 completed treatment or waitlist). Therapists worked with individual families. The CBT model emphasized behavioral experimentation, parent-training, and school consultation. Independent evaluators blind to treatment condition conducted structured diagnostic interviews and parents and children completed anxiety symptom checklists at baseline and posttreatment/postwaitlist.ResultsIn intent-to-treat analyses, 78.5% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 8.7% of the waitlist group. CBT also outperformed the waitlist on diagnostic outcomes and parent reports of child anxiety, but not children's self-reports. Treatment gains were maintained at 3-month follow-up.ConclusionsThe CBT manual employed in this study is one of the first adaptations of an evidence-based treatment for children with autism spectrum disorders. Remission of anxiety disorders appears to be an achievable goal among high-functioning children with autism.
| S-EPMC4231198 | biostudies-literature
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Project description:The purpose of this study was to examine the efficacy of cognitive behavioral therapy (CBT) for anxiety-related disorders based on randomized placebo-controlled trials. We included 41 studies that randomly assigned patients (N = 2,843) with acute stress disorder, generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) to CBT or a psychological or pill placebo condition. Findings demonstrated moderate placebo-controlled effects of CBT on target disorder symptoms (Hedges' g = 0.56), and small to moderate effects on other anxiety symptoms (Hedges' g = 0.38), depression (Hedges' g = 0.31), and quality of life (Hedges' g = 0.30). Response rates in CBT compared to placebo were associated with an odds ratio of 2.97. Effects on the target disorder were significantly stronger for completer samples than intent-to-treat samples, and for individuals compared to group CBT in SAD and PTSD studies. Large effect sizes were found for OCD, GAD, and acute stress disorder, and small to moderate effect sizes were found for PTSD, SAD, and PD. In PTSD studies, dropout rates were greater in CBT (29.0%) compared to placebo (17.2%), but no difference in dropout was found across other disorders. Interventions primarily using exposure strategies had larger effect sizes than those using cognitive or cognitive and behavioral techniques, though this difference did not reach significance. Findings demonstrate that CBT is a moderately efficacious treatment for anxiety disorders when compared to placebo. More effective treatments are especially needed for PTSD, SAD, and PD.
| S-EPMC5992015 | biostudies-literature
Project description:BackgroundPsychiatric inpatients often have limited access to psychotherapeutic education or skills for managing anxiety, a common transdiagnostic concern in severe and acute mental illness. COVID-19-related restrictions further limited access to therapy groups on inpatient psychiatric units. App-based interventions may improve access, but evidence supporting the feasibility of their use, acceptability, and effectiveness in psychiatric inpatient settings is limited. MindShift CBT is a free app based on cognitive behavioral therapy principles with evidence for alleviating anxiety symptoms in the outpatient setting.ObjectiveWe aimed to recruit 24 participants from an acute general psychiatric inpatient ward to a 1-month randomized control study assessing the feasibility and acceptability of providing patients with severe and acute mental illness access to the MindShift CBT app for help with managing anxiety symptoms.MethodsRecruitment, data collection, analysis, and interpretation were completed collaboratively by clinician and peer researchers. Inpatients were randomized to two conditions: treatment as usual (TAU) versus TAU plus use of the MindShift CBT app over 6 days. We collected demographic and quantitative data on acceptability and usability of the intervention. Symptoms of depression, anxiety, and psychological distress were measured in pre- and poststudy surveys for preliminary signals of efficacy. We conducted individual semistructured interviews with participants in the MindShift CBT app group at the end of their trial period, which were interpreted using a standardized protocol for thematic analysis.ResultsOver 4 weeks, 33 inpatients were referred to the study, 24 consented to participate, 20 were randomized, and 11 completed the study. Of the 9 randomized participants who did not complete the study, 7 were withdrawn because they were discharged or transferred prior to study completion, with a similar distribution among both conditions. Among the enrolled patients, 65% (13/20) were admitted for a psychotic disorder and no patient was admitted primarily for an anxiety disorder. The average length of stay was 20 days (SD 4.4; range 3-21) and 35% (7/20) of patients were involuntarily admitted to hospital. Small sample sizes limited accurate interpretation of the efficacy data. Themes emerging from qualitative interviews included acceptability and usability of the app, and patient agency associated with voluntary participation in research while admitted to hospital.ConclusionsOur study benefitted from collaboration between peer and clinician researchers. Due to rapid patient turnover in the acute inpatient setting, additional flexibility in recruitment and enrollment is needed to determine the efficacy of using app-based psychotherapy on an acute psychiatric ward. Despite the limited sample size, our study suggests that similar interventions may be feasible and acceptable for acutely unwell inpatients. Further study is needed to compare the efficacy of psychotherapeutic apps with existing standards of care in this setting.Trial registrationClinicalTrials.gov NCT04841603; https://clinicaltrials.gov/ct2/show/NCT04841603.
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Project description:BackgroundSocial anxiety (SA), a prevalent comorbid condition in psychotic disorders with a negative impact on functioning, requires adequate intervention relatively early. Using a randomized controlled trial, we tested the efficacy of a group cognitive-behavioral therapy intervention for SA (CBT-SA) that we developed for youth who experienced the first episode of psychosis (FEP). For our primary outcome, we hypothesized that compared to the active control of group cognitive remediation (CR), the CBT-SA group would show a reduction in SA that would be maintained at 3- and 6-month follow-ups. For secondary outcomes, it was hypothesized that the CBT-SA group would show a reduction of positive and negative symptoms and improvements in recovery and functioning.MethodNinety-six patients with an FEP and SA, recruited from five different FEP programs in the Montreal area, were randomized to 13 weekly group sessions of either CBT-SA or CR intervention.ResultsLinear mixed models revealed that multiple measures of SA significantly reduced over time, but with no significant group differences. Positive and negative symptoms, as well as functioning improved over time, with negative symptoms and functioning exhibiting a greater reduction in the CBT-SA group.ConclusionsWhile SA decreased over time with both interventions, a positive effect of the CBT-SA intervention on measures of negative symptoms, functioning, and self-reported recovery at follow-up suggests that our intervention had a positive effect that extended beyond symptoms specific to SA.ClinicalTrials.gov identifier: NCT02294409.
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