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Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Tinnitus is one of the most distressing hearing-related symptoms. Innovative ways of managing tinnitus distress and the related healthcare burden of treating tinnitus are required. An internet-based cognitive behavioural therapy (iCBT) intervention has been developed in Sweden to improve access to evidence-based tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus, in the UK. It, furthermore, aims to establish whether there are subgroups of tinnitus sufferers for whom this iCBT intervention may be more suitable. METHODS AND ANALYSIS:A two-armed randomised control trial--with a 1-year follow-up design--will be used to evaluate the effectiveness of iCBT on tinnitus distress. A delayed treatment design using a weekly check-in control group will be used. 70 participants will be randomly assigned to each group by an independent researcher by using a computer-generated randomisation schedule, and after being prestratified for age and tinnitus severity. They will undergo the iCBT e-health intervention online together with audiological therapeutic support. The main outcome measure is the Tinnitus Functional Index. Process evaluation of the intervention will also be conducted. Data analysis will be in accordance with Consolidated Standards of Reporting Trials guidelines. ETHICS AND DISSEMINATION:Ethical approval has been granted. If this intervention proves effective, it may be possible that at least some tinnitus sufferers can be managed though an iCBT e-learning treatment programme. This would be cost effective and potentially will free up services for those with more severe problems that need face-to-face treatment. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov; NCT02370810, date 05/03/2015.

SUBMITTER: Beukes EW

PROVIDER: S-EPMC4593165 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial.

Beukes Eldré W EW Manchaiah Vinaya V Allen Peter M PM Baguley David M DM Andersson Gerhard G

BMJ open 20150923 9

<h4>Introduction</h4>Tinnitus is one of the most distressing hearing-related symptoms. Innovative ways of managing tinnitus distress and the related healthcare burden of treating tinnitus are required. An internet-based cognitive behavioural therapy (iCBT) intervention has been developed in Sweden to improve access to evidence-based tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus, in the UK. It, furthermo ...[more]

PMID: 26399571

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Project description:ObjectivesThe current study examined predictors of outcomes of internet-based cognitive-behavioural therapy (ICBT) for individuals with tinnitus.DesignSecondary analysis of intervention studies.SettingInternet-based guided tinnitus intervention provided in the UK.Participants228 individuals who underwent ICBT.InterventionsICBT.Primary and secondary outcome measuresThe key predictor variables included demographic, tinnitus, hearing-related and treatment-related variables as well as clinical factors (eg, anxiety, depression, insomnia), which can have an impact on the treatment outcome. A 13-point reduction in Tinnitus Functional Index (TFI) scores has been defined as a successful outcome.ResultsOf the 228 subjects who were included in the study, 65% had a successful ICBT outcome. As per the univariate analysis, participants with a master's degree or above had the highest odds of having a larger reduction in tinnitus severity (OR 3.47; 95% CI 1.32 to 12.51), compared with the participants who had education only up to high school or less. Additionally, the baseline tinnitus severity was found to be a significant variable (OR 2.65; 95% CI 1.50 to 4.67) contributing to a successful outcome with the intervention. Both linear and logistic regression models have identified education level and baseline tinnitus severity to be significant predictor variables contributing to a reduction in tinnitus severity post-ICBT. As per the linear regression model, participants who had received disability allowance had shown a 25.3-point lower TFI reduction compared with those who did not experience a decrease in their workload due to tinnitus after adjusting for baseline tinnitus severity and their education level.ConclusionsPredictors of intervention outcome can be used as a means of triaging patients to the most suited form of treatment to achieve optimal outcomes and to make healthcare savings. Future studies should consider including a heterogeneous group of participants as well as other predictor variables not included in the current study.ClinicalTrial.gov Registration: NCT02370810 (completed); NCT02665975 (completed).

Project description:With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.ClinicalTrials.gov: NCT01961479, 9 October 2013.

Project description:ObjectivesTo evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy.DesignA 12 week single blind parallel group randomised controlled trial.SettingAcademic medical centre.Participants94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial.InterventionsParticipants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks.Main outcome measuresThe primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial.ResultsBDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high.ConclusionsCBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide.Trial registration ClinicalTrials.gov ID: NCT02010619.

Dataset Information

Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial.

Publications

Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial.

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