Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States

Introduction: An internet-based cognitive behavioral therapy (ICBT) offers a way to increase access to evidence-based tinnitus care. To increase the accessibility of this intervention, the materials were translated into Spanish to reach Spanish as well as English speakers. A clinical trial indicated favorable outcomes of ICBT for tinnitus for the population of the United States. In view of later dissemination, a way to increase the applicability of this intervention is required. Such understanding is best obtained by considering the perspectives and experiences of participants of an intervention. This study aimed to identify the processes that could facilitate or hinder the clinical implementation of ICBT in the United States.Methods: This study evaluated the processes regarding enrolment, allocation, intervention delivery, the outcomes obtained, and the trial implementation. The study sample consisted of 158 participants who were randomly assigned to the experimental and control group.Results: Although the recruitment was sufficient for English speakers, recruiting the Spanish participants and participants belonging to ethnic minority groups was difficult despite using a wide range of recruitment strategies. The allocation processes were effective in successfully randomizing the groups. The intervention was delivered as planned, but not all the participants chose to engage with the materials provided. Compliance for completing the outcome measures was low. The personal and intervention factors were identified as barriers for the implementation whereas the facilitators included the support received, being empowering, the accessibility of the intervention, and its structure.Conclusion: An understanding regarding the factors contributing to the outcomes obtained, the barriers and facilitators of the results, engagement, and compliance were obtained. These insights will be helpful in preparing for the future dissemination of such interventions.Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04004260. Registered on 2 July 2019.

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Internet-based audiologist-guided cognitive behavioral therapy for tinnitus in the United States: A randomized controlled trial (Preprint)

Journal of Medical Internet Research ◽

10.2196/27584 ◽

2021 ◽

Author(s):

Eldre Beukes ◽

Gerhard Andersson ◽

Marc Fagelson ◽

Vinaya Manchaiah

Keyword(s):

United States ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

The United States ◽

Cognitive Behavioral ◽

Randomized Controlled

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Trauma informed interventions: A systematic review

PLoS ONE ◽

10.1371/journal.pone.0252747 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0252747

Author(s):

Hae-Ra Han ◽

Hailey N. Miller ◽

Manka Nkimbeng ◽

Chakra Budhathoki ◽

Tanya Mikhael ◽

...

Keyword(s):

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Health Inequities ◽

The United States ◽

Psychological Outcomes ◽

Cognitive Behavioral ◽

Health Concern ◽

Ptsd Symptoms ◽

Wide Range ◽

Trauma Informed

Background Health inequities remain a public health concern. Chronic adversity such as discrimination or racism as trauma may perpetuate health inequities in marginalized populations. There is a growing body of the literature on trauma informed and culturally competent care as essential elements of promoting health equity, yet no prior review has systematically addressed trauma informed interventions. The purpose of this study was to appraise the types, setting, scope, and delivery of trauma informed interventions and associated outcomes. Methods We performed database searches— PubMed, Embase, CINAHL, SCOPUS and PsycINFO—to identify quantitative studies published in English before June 2019. Thirty-two unique studies with one companion article met the eligibility criteria. Results More than half of the 32 studies were randomized controlled trials (n = 19). Thirteen studies were conducted in the United States. Child abuse, domestic violence, or sexual assault were the most common types of trauma addressed (n = 16). While the interventions were largely focused on reducing symptoms of post-traumatic stress disorder (PTSD) (n = 23), depression (n = 16), or anxiety (n = 10), trauma informed interventions were mostly delivered in an outpatient setting (n = 20) by medical professionals (n = 21). Two most frequently used interventions were eye movement desensitization and reprocessing (n = 6) and cognitive behavioral therapy (n = 5). Intervention fidelity was addressed in 16 studies. Trauma informed interventions significantly reduced PTSD symptoms in 11 of 23 studies. Fifteen studies found improvements in three main psychological outcomes including PTSD symptoms (11 of 23), depression (9 of 16), and anxiety (5 of 10). Cognitive behavioral therapy consistently improved a wide range of outcomes including depression, anxiety, emotional dysregulation, interpersonal problems, and risky behaviors (n = 5). Conclusions There is inconsistent evidence to support trauma informed interventions as an effective approach for psychological outcomes. Future trauma informed intervention should be expanded in scope to address a wide range of trauma types such as racism and discrimination. Additionally, a wider range of trauma outcomes should be studied.

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Cost-effectiveness of digital cognitive behavioral therapy (Sleepio) for insomnia: a Markov simulation model in the United States

SLEEP ◽

10.1093/sleep/zsaa223 ◽

2020 ◽

Author(s):

Michael Darden ◽

Colin A Espie ◽

Jenna R Carl ◽

Alasdair L Henry ◽

Jennifer C Kanady ◽

...

Keyword(s):

United States ◽

Cost Effectiveness ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Cost Effective ◽

The United States ◽

Cognitive Behavioral ◽

Life Years ◽

Insomnia Treatment ◽

Group Cbt

Abstract Study Objectives To examine the cost-effectiveness and potential net monetary benefit (NMB) of a fully automated digital cognitive behavioral therapy (CBT) intervention for insomnia compared with no insomnia treatment in the United States (US). Similar relative comparisons were made for pharmacotherapy and clinician-delivered CBT (individual and group). Methods We simulated a Markov model of 100,000 individuals using parameters calibrated from the literature including direct (treatment) and indirect costs (e.g. insomnia-related healthcare expenditure and lost workplace productivity). Health utility estimates were converted into quality-adjusted life years (QALYs) and one QALY was worth $50,000. Simulated individuals were randomized equally to one of five arms (digital CBT, pharmacotherapy, individual CBT, group CBT, or no insomnia treatment). Sensitivity was assessed by bootstrapping the calibrated parameters. Cost estimates were expressed in 2019 US dollars. Results Digital CBT was cost beneficial when compared with no insomnia treatment and had a positive NMB of $681.06 (per individual over 6 months). Bootstrap sensitivity analysis demonstrated that the NMB was positive in 94.7% of simulations. Relative to other insomnia treatments, digital CBT was the most cost-effective treatment because it generated the smallest incremental cost-effectiveness ratio (−$3,124.73). Conclusions Digital CBT was the most cost-effective insomnia treatment followed by group CBT, pharmacotherapy, and individual CBT. It is financially prudent and beneficial from a societal perspective to utilize automated digital CBT to treat insomnia at a population scale.

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Features, Functionality, and Acceptability of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States

American Journal of Audiology ◽

10.1044/2020_aja-20-00002 ◽

2020 ◽

Vol 29 (3) ◽

pp. 476-490

Author(s):

Vinaya Manchaiah ◽

George Vlaescu ◽

Srinivas Varadaraj ◽

Elizabeth Parks Aronson ◽

Marc A. Fagelson ◽

...

Keyword(s):

United States ◽

Health Care ◽

Cognitive Behavioral Therapy ◽

Health Care Professionals ◽

Behavioral Therapy ◽

The United States ◽

Cognitive Behavioral ◽

Software Safety ◽

Regulatory Aspects ◽

The United Kingdom

Objective Although tinnitus is one of the most commonly reported symptoms in the general population, patients with bothersome tinnitus are challenged by issues related to accessibility of care and intervention options that lack strong evidence to support their use. Therefore, creative ways of delivering evidence-based interventions are necessary. Internet-based cognitive behavioral therapy (ICBT) demonstrates potential as a means of delivering this support but is not currently available in the United States. This article discusses the adaptation of an ICBT intervention, originally used in Sweden, Germany, and the United Kingdom, for delivery in the United States. The aim of this study was to (a) modify the web platform's features to suit a U.S. population, (b) adapt its functionality to comply with regulatory aspects, and (c) evaluate the credibility and acceptability of the ICBT intervention from the perspective of health care professionals and patients with bothersome tinnitus. Materials/Method Initially, the iTerapi ePlatform developed in Sweden was adopted for use in the United States. Functional adaptations followed to ensure that the platform's functional and security features complied with both institutional and governmental regulations and that it was suitable for a U.S. population. Following these adaptations, credibility and acceptance of the materials were evaluated by both health care professionals ( n = 11) and patients with bothersome tinnitus ( n = 8). Results Software safety and compliance regulatory assessments were met. Health care professionals and patients reported favorable acceptance and satisfaction ratings regarding the content, suitability, presentation, usability, and exercises provided in the ICBT platform. Modifications to the features and functionality of the platform were made according to user feedback. Conclusions Ensuring that the ePlatform employed the appropriate features and functionalities for the intended population was essential to developing the Internet-based interventions. The favorable user evaluations indicated that the intervention materials were appropriate for the tinnitus population in the United States.

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Effectiveness of Usual-Care Cognitive-Behavioral Therapy for Adolescents with Depressive Disorders Rated by Parents and Patients

10.21203/rs.3.rs-61613/v1 ◽

2020 ◽

Author(s):

Daniel Walter ◽

Jana Buschsieweke ◽

Lydia Dachs ◽

Hildegard Goletz ◽

Anja Goertz-Dorten ◽

...

Keyword(s):

Cognitive Behavioral Therapy ◽

Depressive Disorders ◽

Behavioral Therapy ◽

Routine Care ◽

Self Report ◽

Cognitive Behavioral ◽

Effect Sizes ◽

Control Group ◽

Parent Rating ◽

Wide Range

Abstract BackgroundDepressive disorders are common in adolescence and are associated with a wide range of negative long-term outcomes. Highly controlled randomized controlled trials (RCT) provide considerable evidence for the efficacy of cognitive-behavioral therapy (CBT) as a treatment for depression, but the effectiveness of CBT under routine care conditions remains unproven.MethodsIn the present observational study, the changes achieved through routine CBT in adolescents with depressive disorders treated in a university outpatient clinic were analyzed, and compared to a historical control group of adolescents with depressive disorders who had received treatment as usual. At the start and end of treatment (pre- and post-assessment), parent and self-ratings of the German versions of the Youth Self-Report (YSR), the Child Behavior Checklist (CBCL) and rating scales for depressive symptoms (FBB-DES, SBB-DES) were assessed. A total of 331 adolescents aged 11–18 years with complete data were assessed for the main analysis.ResultsThe analysis yielded small to large pre-post effect sizes (Cohen’s d) for the total sample (d = 0.33 to d = 0.82) and large effect sizes for adolescents who were rated in the clinical range on each (sub)scale at the start of treatment (d = 0.85 to d = 1.30). When comparing patients in the clinical range with historical controls, medium to large net effect sizes (d = 0.53 to d = 2.09) emerged for the total scores in self- and parent rating. However, a substantial proportion of the sample remained in the clinical range at the end of treatment.ConclusionsThese findings suggest that CBT is effective for adolescents with depressive disorders when administered under routine care conditions, but the results must be interpreted with caution due to the lack of a direct control condition.Trial registrationDRKS, DRKS00021518. Registered 27 April 2020 - Retrospectively registered, http://drks.de

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Efficacy of Online Versus In-Person Cognitive Behavioral Therapy for Insomnia

Proceedings of IMPRS ◽

10.18060/24800 ◽

2020 ◽

Vol 3 ◽

Author(s):

Emily Wilson ◽

Aaron Roberts

Keyword(s):

Cognitive Behavioral Therapy ◽

Clinical Decision Making ◽

Behavioral Therapy ◽

Adult Population ◽

Severity Index ◽

The United States ◽

Cognitive Behavioral ◽

Control Group ◽

Insomnia Severity ◽

Over Time

Background and Hypothesis: Up to 30% of the adult population may suffer from insomnia symptoms. Insomnia not only diminishes the individual’s quality of life, but also has a broad financial impact, costing the United States over $100 billion per year. Systemic barriers limit access to cognitive behavioral therapy for insomnia (CBT-I), the first-line treatment for insomnia. However, newly developed internet CBT-I (iCBT-I) programs, if effective, may reduce this disparity. In this study, we hypothesized that there is no difference in the efficacy of the experimental iCBT-I and the control CBT-I interventions in reducing insomnia severity over time. Project Methods: A projected 120 participants will be recruited for this non-inferiority prospective cohort study. 60 patients will be assigned to each arm of the study (CBT-I and iCBT-I). The control group will attend 6 in-person CBT-I sessions over 6 weeks. The experimental group will complete the iCBT-I program Go! To Sleep over 6 weeks. Participants will complete the Insomnia Severity Index (ISI) before and after treatment, as well as 3, 6, and 12 months after finishing the program. The Kruskal-Wallis statistical test will utilize ISI data to compare efficacy of the interventions over time. Results: Based on previous literature, the projected results of this study align with the hypothesis that there will be no difference in efficacy of the CBT-I and iCBT-I interventions over time. Potential Impact: If indeed there is no difference in effectiveness between the iCBT-I program and in-person CBT-I, this result would have implications in clinical decision-making. Improved access to iCBT-I may reduce prescriptions for addictive pharmacologic treatments, as well as offer an inexpensive, convenient, and effective treatment for insomnia. Future studies could compare efficacy of iCBT-I in patients with co-morbidities, such as anxiety or depression.

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Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke

Stroke ◽

10.1161/strokeaha.120.029042 ◽

2020 ◽

Vol 51 (8) ◽

pp. 2297-2306 ◽

Cited By ~ 1

Author(s):

Ho-Yan Yvonne Chun ◽

Alan J. Carson ◽

Athanasios Tsanas ◽

Martin S. Dennis ◽

Gillian E. Mead ◽

...

Keyword(s):

Clinical Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Stroke Survivors ◽

Unique Identifier ◽

Access To Treatment ◽

Sample Mean ◽

Intervention Delivery

Background and Purpose: 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 measuring objective outcomes in this clinical trial. Methods: We recruited adult community-based stroke patients (n=27) and randomly allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an active comparator (n=13). Results: In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible. All participants completed all TASK-CBT sessions (14/14). Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15). Conclusions: Our preliminary feasibility data from the current study support a larger definitive clinical trial and the use of wrist-worn actigraphy sensor in anxious stroke survivors. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03439813.

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The Effects of Cognitive Behavioral Therapy on Depression and Anxiety among Patients with Thalassemia: a Randomized Controlled Trial

Journal of Caring Sciences ◽

10.15171/jcs.2018.033 ◽

2018 ◽

Vol 7 (4) ◽

pp. 219-224 ◽

Cited By ~ 1

Author(s):

Fateme Mohamadian ◽

Maryam Bagheri ◽

Maryam Sadat Hashemi ◽

Hossein Komeili Sani

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Control Group ◽

Depression And Anxiety ◽

Randomized Controlled ◽

Post Test ◽

Experimental Group

Introduction: Thalassemia is a chronic hereditary anemia which can be associated with different psychological, emotional, and behavioral problems such as depression and anxiety. This study aimed to evaluate the effects of cognitive behavioral therapy on depression and anxiety of patients with thalassemia. Methods: This was a randomized controlled trial study. A total of 76 patients were randomly allocated to an experimental (n=38) and a control group (n=38). Patients in the experimental group were provided with cognitive behavioral therapy while their counterparts in the control group received routine care services. Depression and anxiety assessments were performed four weeks before the intervention as well as four and six weeks after that. Between-group and within-group comparisons were performed through the independent-sample t-tests and the paired sample t-test, respectively Results: The post-test mean score of anxiety in the experimental group was significantly lower than that for the control group, while there was no significant difference between the groups regarding the post-test mean score of depression. The mean score of depression in both study groups decreased significantly. The rate of decrease in the experimental group was significantly greater than that in the control group. Conclusion: Cognitive behavioral therapy can be used to prevent or alleviate depression and anxiety among patients.

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