Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States.
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SUBMITTER: Beukes EW
PROVIDER: S-EPMC8635963 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Patients often report that living with a condition such as tinnitus can be debilitating, worrying, and frustrating. Efficient ways to foster management strategies for individuals with tinnitus and promoting tinnitus self-efficacy are needed. Internet-based cognitive behavioral therapy (ICBT) for tinnitus shows promise as an evidence-based intervention in Europe, but is not available in the United States. The aim of this pilot study was to evaluate the feasibility of an ICBT intervention for tinnitus in the United States. Method This study reports the Phase 1 trial intended to support implementation of a larger randomized clinical trial (RCT) comparing ICBT to a weekly monitoring group. As a pilot study, a single-group pretest-posttest design was used to determine outcome potential, recruitment strategy, retention, and adherence rates of ICBT for tinnitus. The primary outcome was a change in tinnitus distress. Secondary outcome measures included measures of anxiety, depression, insomnia, tinnitus cognitions, hearing-related difficulties, and quality of life. Results Of the 42 screened participants, nine did not meet the inclusion criteria and six withdrew. There were 27 participants who completed the intervention, with a mean age of 55.48 (± 9.9) years. Feasibility was established, as a large pretest-posttest effect size of d = 1.6 was found for tinnitus severity. Large pretest-posttest effect sizes were also found for tinnitus cognitions and hearing-related effects, and a medium effect was found for insomnia and quality of life. Treatment adherence varied with a retention rate of 85% (n = 23) at post-intervention assessment and 67% (n = 18) for the follow-up assessment. Conclusions This pilot study supported the feasibility of ICBT for tinnitus in the United States. Ways of improving intervention retention and recruitment rates need to be explored in future ICBT studies. Protocol refinements that were identified will be implemented prior to further RCTs to investigate the efficacy of ICBT for tinnitus in the United States. Supplemental Material https://doi.org/10.23641/asha.15501135.
| S-EPMC8642102 | biostudies-literature
Project description:Tinnitus service provision in the United Kingdom has been investigated from the healthcare provider's perspective demonstrating considerable regional variation particularly regarding availability of psychological treatments. An audiological-based tinnitus service, however, was reportedly available for all tinnitus patients in the UK. The aim of the current study was to define and evaluate nationwide tinnitus healthcare services from the patients' viewpoint.Secondary analyses were performed on data from a 33-item questionnaire provided by the British Tinnitus Association. The questionnaire had been distributed via email and social media.Responses from 937 participants who had or had previously experienced tinnitus were analysed. All but one person had at some time consulted their GP. About one in five received medication in primary care. The majority were referred to secondary care, generally an ENT surgeon or audiovestibular physician; some were referred directly to audiological services. In secondary care the majority underwent audiometric testing and over half underwent MRI scanning. Drugs were prescribed less frequently in secondary care. About one third of patients were referred onwards from diagnostic services in secondary care to receive therapeutic interventions for tinnitus. Therapy was generally delivered by an audiologist or hearing therapist. Just under two fifths of people discharged from secondary care returned to their GP, with most returning within one year. Over a third of this group were re-referred to secondary care. Few patients saw a psychologist (2.6%) though some psychological treatments were delivered by appropriately trained audiologists. Negative counselling from healthcare professionals in both primary and secondary care settings was reported.Although the UK has developed a national service for patients with tinnitus many people find it difficult to access, being blocked at the primary care level or after secondary care diagnostic services. Many of those discharged from secondary care return to their GP within a short space of time and are re-referred to secondary care creating an unsatisfactory and expensive revolving-door pattern of healthcare. Despite psychological treatment modalities having the best evidence base for successful tinnitus management, only a minority of tinnitus patients ever get to meet a psychologist.
| S-EPMC5809968 | biostudies-other
Project description:BackgroundTinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States.ObjectiveThe aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention.MethodsA 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life.ResultsInternet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3.ConclusionsThis study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers.Trial registrationClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.
| S-EPMC8887633 | biostudies-literature
Project description:ObjectivesThis study investigated the long-term outcomes 1-year after undertaking an Internet-based cognitive behavioural therapy (ICBT) for tinnitus distress in a US population. Secondary aims were to identify the effects on additional difficulties associate with tinnitus and any unwanted events related to ICBT for tinnitus.MethodsA repeated-measures design with 4 time points was used. Participants previously undertaking two randomized ICBT efficacy trials for tinnitus in the US were invited to participate. Of the 200 invited, 132 (66 %) completed the 1-year follow-up questionnaire. The primary outcome was a change in tinnitus distress from baseline at one year post-intervention, as assessed by the Tinnitus Functional Index. Secondary assessment measures were included for anxiety, depression, insomnia, hearing disability, hyperacusis, tinnitus cognitions and health-related quality of life.ResultsUndertaking ICBT for tinnitus led to significant improvements 1-year post-intervention for tinnitus severity, with a large effect size (d = 1.06; CI: 0.80 to 1.32). Medium effects were found for anxiety (d = 0.54; CI: 0.29 to 0.79), depression (d = 0.46; CI: 0.21 to 0.70), insomnia (d = 0.47; CI: 0.22 to 0.72), and tinnitus cognitions (d = 0.43, CI: 0.18 to 0.68). Small effect sizes were found for hearing disability, hyperacusis and health-related quality of life. Adverse events related to the intervention were only reported by 1 participant.ConclusionsThe benefits of audiologist-guided ICBT for tinnitus and tinnitus-related difficulties were maintained 1-year post-intervention with very few adverse events reported. Ways of disseminate evidence-based easily accessible interventions to the general population with bothersome tinnitus should be sought.
| S-EPMC9637888 | biostudies-literature
Project description:Internet-based cognitive behavioral therapy (iCBT) programs have the potential to improve access to mental healthcare, but they are not viewed as acceptable nor widely utilized by the general public. This study tested whether two acceptance-facilitating interventions improved acceptability and uptake-related behavior for therapist assisted and self-guided iCBT. Participants were randomly assigned to read a treatment rationale for iCBT (vs. a brief definition) and to receive a small financial incentive (or not) for seeking more information about evidence-based iCBT programs. Participants (N = 662) were a diverse group recruited from a University participant pool and the surrounding community. Participants completed standardized measures of attitudes toward and outcome expectancy for iCBT and a single question about willingness to use it and were given the opportunity to get information about accessing evidence-based iCBT programs. A series of MANCOVAs showed small, positive effects of the treatment rationale on attitudes and outcome expectancy for both self-guided and therapist-assisted iCBT, but not for willingness to use it. A hierarchical logistic regression model found no effect of the treatment rationale or financial incentive on whether participants sought additional information about how to access iCBT, although psychopathology symptoms and identifying as White or multiracial were positively associated with information-seeking. Inconsistent with past research, participants rated therapist-assisted and self-guided iCBT as equally acceptable. Participants recruited from the community reported greater willingness to use iCBT than University students. These results underscore the urgent need for further research toward improving the acceptability and uptake of iCBT so that it may better fulfill its potential to fill the gap in unmet mental health need.
| S-EPMC8521972 | biostudies-literature
Project description:Background: Informal caregivers are individuals who provide care for ill, frail, or otherwise dependent family members, siblings, or friends. Due to the caregiving demands, informal caregivers are known to experience negative mental health symptoms, such as stress or anxiety. Interventions based on Internet-based Cognitive Behavioral Therapy (ICBT) principles have been previously found to be effective for different populations and could also be considered as a plausible support option for informal caregivers. However, findings regarding effectiveness alone might not be sufficient for informing about the overall feasibility of the intervention. Objective: The aim of this process evaluation study was to evaluate the feasibility of a previously developed ICBT intervention for informal caregivers in Lithuania. More specifically, we evaluated the suitability of the intervention in relation to its content and delivery mode. Methods: Two studies were conducted. Study 1 consisted of participant evaluations of an 8-week, 8-module long therapist supported ICBT intervention. Evaluations for the Study 1 were retrieved from previously unused data, obtained from pilot testing of the intervention in which 63 informal caregivers took part. The evaluations contained of qualitative data (participant comments), as well as quantitative data (evaluations of each of the sessions). The Study 2 was an online stakeholder focus-group discussion conducted via Zoom. Eight stakeholders took part in the discussion, among whom there were social workers, medical professionals as well as individuals with caregiving experience themselves. Data were analyzed using descriptive statistics, thematic analysis, and data coding. Results: Results of the Study 1 showed that most of the pilot randomized controlled trial participants evaluated content and format of the intervention positively. These results were complemented by the findings in the Study 2, in which stakeholders evaluated the intervention as suitable and promising. In addition, stakeholders made certain suggestions for improving the intervention's usability for the informal caregivers. This included improving the instructions, providing with more guidance, and considering personalization options. Conclusion: The process evaluation helped to evaluate the feasibility of the ICBT intervention for informal caregivers in Lithuania from the two perspectives: users and stakeholders. Our findings suggest that the intervention is suitable for the target population.
| S-EPMC8632733 | biostudies-literature
Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) for tinnitus is an evidence-based intervention. The components of ICBT for tinnitus have, however, not been dismantled and thus the effectiveness of the different therapeutic components is unknown. It is, furthermore, not known if heterogeneous tinnitus subgroups respond differently to ICBT.AimsThis dismantling study aimed to explore the contribution of applied relaxation within ICBT for reducing tinnitus distress and comorbidities associated with tinnitus. A secondary aim was to assess whether outcomes varied for three tinnitus subgroups, namely those with significant tinnitus severity, those with low tinnitus severity, and those with significant depression.MethodsA parallel randomized controlled trial design (n = 126) was used to compare audiologist-guided applied relaxation with the full ICBT intervention. Recruitment was online and via the intervention platform. Assessments were completed at four-time points including a 2-month follow-up period. The primary outcome was tinnitus severity as measured by the Tinnitus Functional Index. Secondary outcomes were included for anxiety, depression, insomnia, negative tinnitus cognitions, health-related quality of life, hearing disability, and hyperacusis. Treatment engagement variables including the number of logins, number of modules opened, and the number of messages sent. Both an intention-to-treat analysis and completer's only analysis were undertaken.ResultsEngagement was low which compromised results as the full intervention was undertaken by few participants. Both the ICBT and applied relaxation resulted in large reduction of tinnitus severity (within-group effect sizes d = 0.87 and 0.68, respectively for completers only analysis), which were maintained, or further improved at follow-up. These reductions in tinnitus distress were greater for the ICBT group, with a small effect size differences (between-group d = 0.15 in favor of ICBT for completers only analysis). Tinnitus distress decreased the most at post-intervention for those with significant depression at baseline. Both ICBT and applied relaxation contributed to significant reductions on most secondary outcome measures, with no group differences, except for a greater reduction of hyperacusis in the ICBT group.ConclusionDue to poor compliance partly attributed to the COVID-19 pandemic results were compromised. Further studies employing strategies to improve compliance and engagement are required. The intervention's effectiveness increased with initial level of tinnitus distress; those with the highest scores at intake experienced the most substantial changes on the outcome measures. This may suggest tailoring of interventions according to tinnitus severity. Larger samples are needed to confirm this.
| S-EPMC8141772 | biostudies-literature
Project description:Cognitive behavioral therapy encourages acquisition, practice, and use of a range of specific coping strategies to enhance perceptions of self-control and self-efficacy for patients with tinnitus.
| S-EPMC6263445 | biostudies-literature
Project description:Background A significant proportion of individuals with distressing tinnitus also report insomnia. Limited, but emerging, evidence suggests that tinnitus-related insomnia cannot be explained only by the presence of tinnitus and that sleep-related cognitive–behavioral processes may play a key role in exacerbating tinnitus-related insomnia. Objectives This study aimed to assess whether sleep-related cognitions and behaviors believed to maintain insomnia disorder are present in individuals with tinnitus-related insomnia. Methods This between-groups study recruited 180 participants online for four groups: tinnitus-related insomnia (N = 49), insomnia disorder without tinnitus (N = 34), tinnitus sufferers who are good sleepers (N = 38), and controls (N = 59). They completed questionnaires assessing insomnia severity, sleep-related cognitions and behaviors, sleep quality, anxiety, and depression. People with tinnitus completed a measure of tinnitus severity and rated the loudness of their tinnitus on a subjective measure. Results Linear regression demonstrated that group significantly predicted sleep related thoughts and behaviors, and sleep quality. Pairwise comparisons showed that the tinnitus-related insomnia group had significantly greater insomnia-related thoughts and behaviors and significantly worse sleep quality than tinnitus-good sleepers. No differences were seen between the tinnitus-related insomnia and the insomnia groups. The tinnitus-related insomnia group had significantly higher depression, anxiety, and tinnitus distress than tinnitus-good sleepers. Conclusion Findings suggest that tinnitus-related insomnia may be maintained by cognitive–behavioral processes similar to those found in insomnia disorder. Such processes are more important than tinnitus severity when understanding sleep disturbance. People with tinnitus-related insomnia may benefit from treatments such as cognitive–behavioral therapy for insomnia.
| S-EPMC10064054 | biostudies-literature
Project description:PurposeInternet-based cognitive behavioral therapy (ICBT) has been found to be effective for tinnitus management, although there is limited understanding about who will benefit the most from ICBT. Traditional statistical models have largely failed to identify the nonlinear associations and hence find strong predictors of success with ICBT. This study aimed at examining the use of an artificial neural network (ANN) and support vector machine (SVM) to identify variables associated with treatment success in ICBT for tinnitus.MethodThe study involved a secondary analysis of data from 228 individuals who had completed ICBT in previous intervention studies. A 13-point reduction in Tinnitus Functional Index (TFI) was defined as a successful outcome. There were 33 predictor variables, including demographic, tinnitus, hearing-related and treatment-related variables, and clinical factors (anxiety, depression, insomnia, hyperacusis, hearing disability, cognitive function, and life satisfaction). Predictive models using ANN and SVM were developed and evaluated for classification accuracy. SHapley Additive exPlanations (SHAP) analysis was used to identify the relative predictor variable importance using the best predictive model for a successful treatment outcome.ResultsThe best predictive model was achieved with the ANN with an average area under the receiver operating characteristic value of 0.73 ± 0.03. The SHAP analysis revealed that having a higher education level and a greater baseline tinnitus severity were the most critical factors that influence treatment outcome positively.ConclusionsPredictive models such as ANN and SVM help predict ICBT treatment outcomes and identify predictors of outcome. However, further work is needed to examine predictors that were not considered in this study as well as to improve the predictive power of these models.Supplemental materialhttps://doi.org/10.23641/asha.21266487.
| S-EPMC9907438 | biostudies-literature