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...

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Main Authors: Eldre W. Beukes, Gerhard Andersson, Vinaya Manchaiah
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-11-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.771646/full
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author Eldre W. Beukes
Eldre W. Beukes
Eldre W. Beukes
Gerhard Andersson
Gerhard Andersson
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
author_facet Eldre W. Beukes
Eldre W. Beukes
Eldre W. Beukes
Gerhard Andersson
Gerhard Andersson
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
author_sort Eldre W. Beukes
collection DOAJ
description 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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spelling doaj.art-2fa90e706f444cd5b6f870abcbc50d8d2022-12-21T21:21:08ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-11-01810.3389/fmed.2021.771646771646Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United StatesEldre W. Beukes0Eldre W. Beukes1Eldre W. Beukes2Gerhard Andersson3Gerhard Andersson4Vinaya Manchaiah5Vinaya Manchaiah6Vinaya Manchaiah7Vinaya Manchaiah8Department of Speech and Hearing Sciences, Lamar University, Beaumont, TX, United StatesVision and Hearing Sciences Research Centre, School of Psychology and Sport Sciences, Anglia Ruskin University, Cambridge, United KingdomVirtual Hearing Lab, a Collaborative Initiative Between Lamar University, Beaumont, TX, United States, and the University of Pretoria, Pretoria, South AfricaDepartment of Behavioral Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, SwedenDivision of Psychiatry, Department of Clinical Neuroscience, Karolinska Institute, Stockholm, SwedenDepartment of Speech and Hearing Sciences, Lamar University, Beaumont, TX, United StatesVirtual Hearing Lab, a Collaborative Initiative Between Lamar University, Beaumont, TX, United States, and the University of Pretoria, Pretoria, South AfricaDepartment of Speech-Language Pathology and Audiology, University of Pretoria, Pretoria, South AfricaDepartment of Speech and Hearing, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, IndiaIntroduction: 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.https://www.frontiersin.org/articles/10.3389/fmed.2021.771646/fullprocess evaluationclinical trialinternet-interventionstinnituscognitive behavioral therapydigital therapeutics
spellingShingle Eldre W. Beukes
Eldre W. Beukes
Eldre W. Beukes
Gerhard Andersson
Gerhard Andersson
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
Vinaya Manchaiah
Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
Frontiers in Medicine
process evaluation
clinical trial
internet-interventions
tinnitus
cognitive behavioral therapy
digital therapeutics
title Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
title_full Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
title_fullStr Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
title_full_unstemmed Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
title_short Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States
title_sort patient uptake experiences and process evaluation of a randomized controlled trial of internet based cognitive behavioral therapy for tinnitus in the united states
topic process evaluation
clinical trial
internet-interventions
tinnitus
cognitive behavioral therapy
digital therapeutics
url https://www.frontiersin.org/articles/10.3389/fmed.2021.771646/full
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