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

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  • November 29, 2016
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This intensive masterclass in Copenhagen, Denmark, is designed for those who wish to  provide specialised care for patients experiencing troublesome tinnitus and hyperacusis. Only randomized controlled trials that used validated questionnaire measures of symptoms (i.e., measures of tinnitus distress, anxiety, depression) were included. Cognitive behavioural therapy (CBT) uses relaxation, cognitive restructuring of the thoughts and exposure to exacerbating situations in order to promote habituation and may benefit tinnitus patients, as may the treatment of associated psychological conditions. I have worked with people in other areas of the UK and from as far away as New Zealand and Australia. Around five million people in the UK alone suffer with tinnitus in some pint in their lives. If ICBT by tinnitus suffering in the UK is possible, it can cover a space for those who have not had access to appropriate services of tinnitus. The main outcome was measured using the Hallam tinnitus questionnaire.

It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt. A study to determine whether iCBT could be a suitable intervention is, therefore, of value. The aim of this study is to further our knowledge of the feasibility and effectiveness of iCBT for tinnitus management in the UK. We also explored if either type of treatment for cochlear implant users needed any modifications to make them more suitable for this group of tinnitus sufferers. This will be an internet-based study run in the UK. This intervention study will be implemented as a two-armed RCT, with a 1-year follow-up, to evaluate the effectiveness of iCBT for tinnitus distress. An effectiveness trial has been selected to increase the extent to which the study results can be generalised, and will be used to identify for which subgroups of tinnitus sufferers this is a suitable intervention.

Many people have found that a combination of Hypnotherapy, CBT and Mindfulness improves the quality of their lives beyond their expectations. The objective is to test the superiority of the intervention, with the hypothesis that the treatment group will perform better than the WCI group. These groups will be followed prospectively for 1 year, to establish the long-term effectiveness of the intervention programme. There will be two study groups. The Test Group will receive the 8-week duration iCBT treatment following baseline measurements and allocation (after T0). The WCI Control Group will be monitored during the active treatment phase by means of the Tinnitus Handicap Inventory—Screening version (THI-S),25 but will have no other contact or involvement in the study during this period. Because the diagnosis of misophonia was only established in 2001, it is true that the vast majority of family doctors have never heard of the condition.

A clinical evaluation prior to partaking in the study is desirable to rule out the presence of a serious auditory pathology or associated psychological problems, which may be related to having tinnitus.26 If there are any concerns, a letter will be provided to the participants to give to their general practitioner for further tinnitus management. Recruitment will be UK-wide, using as many different forms as possible to achieve adequate participant enrolment. Information about the study will be advertised at tinnitus and hearing-related support groups and charities, in their newsletters and drop-in centres. It will further be advertised in audiology departments and by using social media. Talks to professionals, such as ENT consultants and Audiologists, will also be given to introduce the study and aid recruitment. Those interested can obtain information and register interest on the study website. Sample size estimation was calculated using Power and Sample Size Programme, V.3.1.2, and based on achieving a clinically relevant change of 13 points (SD=24.7) in the main outcome measure to be used for this study, the TFI.27 This indicated 30 participants were required per group—with an allocation ratio of 1:1—to achieve a two-sided significance level of 0.05 and effect size of 0.8.

As these calculations are based on a fairly new outcome measure and there may be dropouts, an additional 40 participants will be added to ensure that there is enough valid data to draw conclusions from. Using a unit cost for clinical psychologists of £75 per hour of patient contact (Curtis, 2009), the total cost of providing either CBT or applied relaxation would reach £1,125 per person treated in 2009 prices. Support and guidance is given and the aim is to promote awareness and productivity. Participants will be randomly assigned to either the control or experimental group with a 1:1 allocation with the use of a computer-generated randomisation schedule (http://www.randomizer.org/) by an independent researcher. To prevent an unequal distribution among groups, participants will be prestratified on the basis of age (≤60 or >60 years) and tinnitus severity (TFI≤50 or >50). Furthermore, block randomisation, with blocks of four, will be applied to ensure equal group sizes within each criteria stratification. The intervention to be followed is built on an iCBT self-help programme for reducing tinnitus distress as developed by Andersson et al.19 It incorporates a combination of a cognitive rational28 and learning theory approach.29 The original intervention was largely text based.

Sometimes it can help to remember that after loud sound exposure it can help to take it a bit easy around sound for awhile. This will ensure the intervention is visually stimulating, engaging, and responsive to participants’ progress. The intervention consists of fixed and optional modules, covered over a period of 8 weeks, as shown in table 1. The modules contain a mixture of information, videos, quizzes, diagrams, suggested techniques to apply to daily life, worksheets to keep track of progress, solutions for common problems, and downloadable information. Data for model 1 (Panic Online versus information control) were based on the guideline meta-analysis of KLEIN2006 and RICHARDS2006A. This therapeutic alliance will allow for feedback and assistance if participants have any difficulties, and has shown better outcomes than internet interventions without this communication.30 The clinician will contact the participants who have not completed their weekly progress worksheets to ensure that they are assisted as required. Digital therapeutics are health or social care interventions delivered either wholly or significantly through a smartphone or a laptop.

As tinnitus therapy is largely delivered by the audiology community in the UK, an experienced audiological scientist, registered with the Health Professions Council, will undertake the role of supporting the participants; this will help to maintain consistency with the standard approach. Support will, however, be provided by a psychologist, with experience in iCBT interventions, and a protocol for dealing with different situations will be used. The assessment battery will consist of a screening eligibility questionnaire and relevant self-reported outcome measures that are related to areas which may be affected by tinnitus. Outcome measures for tinnitus severity, hearing handicap, insomnia, cognitive functioning, hyperacusis, anxiety, depression and life satisfaction were, therefore, selected. Careful consideration was given to ensure each questionnaire was as brief as possible and had good psychometric properties, as seen in table 2. Also, the outcomes that were selected had to be aligned with the International Classification of Functioning, Disability and Health (ICF)31 framework in the domains of activity limitation and participation restriction. Eligibility screening: A range of demographic, tinnitus-specific and health-related questions will be used to determine demographic variability and study eligibility.

Open-ended questions asking about positive and negative experiences related to having tinnitus will also be included in the questionnaire. As there is a strong relationship between tinnitus and hearing difficulties,7 the Hearing Handicap Inventory for Adults—Screening version (HHIA-S)34 will be administered to quantify perceived hearing handicap. Relaxation techniques: a series of physical exercises that may help you relax and control your breathing. As sleep disturbances are commonly associated with tinnitus,35 the Insomnia Severity Index (ISI)36 will be included. This questionnaire assesses the nature, severity, and impact of insomnia by assessing sleep duration, sleep quality, the negative impact on daily functioning, and psychological well-being. As having tinnitus may disrupt cognitive functioning,37 the Cognitive Failures Questionnaire (CFQ)38 will be included, which has been designed to assess a patient’s proneness to committing cognitive slips and errors in the completion of everyday tasks, such as failures in perception, memory, and motor functions. As there is a high comorbidity of hyperacusis (a reduced tolerance for everyday sounds)39 in those with tinnitus,40 the Hyperacusis Questionnaire41 will be administered.

Although further work on the structure of this questionnaire is required to establish its reliability for measuring hyperacusis in the tinnitus research population, the scores obtained will be useful to compare preintervention and postintervention changes. As anxiety and depression are common comorbid conditions in individuals with tinnitus,6 the Patient Health Questionnaire (PHQ-9),42 to measure depression severity, and the Generalised Anxiety Disorder 7-item (GAD-7) scale,43 to assess anxiety severity, will be administered. To include a measure of quality of life, the Satisfaction with Life Scales44 will be used for assessing global life satisfaction. For the purpose of this study, it was felt that the questions in this measure were more appropriate than those relating to longer quality of life measures, which include areas of mobility and self-care that are not directly targeted by this study. The format of the questionnaire delivery will remain consistent in the study’s online questionnaires. Not all questionnaires to be used have been validated for internet use. Previous research has found comparable results in terms of psychometric properties between computer and paper questionnaire delivery, with high test–retest reliability and completion rate on the internet.46 ,47 See table 3 for the schedule of outcome measure delivery.

These processes will be monitored during the intervention by reflecting on the study procedures and participants’ experiences. ? All materials will be piloted prior to running the study. Both professionals and those with tinnitus will test all aspects of the platform. A Likert scale questionnaire will be administered, asking specific questions related to the suitability, usability, content and experiences with the intervention and questionnaires, together with open-ended questions. The aim will be to identify any hindrances regarding use of the platform and possible barriers to participation. If any major changes are required, the ethical committee and trial body will be notified.

Further feasibility measures will include the recruitment rates, retention of participants, compliance and acceptability of the intervention by participants. The feasibility of having a professionally trained Audiologist running the intervention under supervision instead of a psychologist will also be evaluated. All data will be collected online. Baseline data will be collected at pretreatment (−T1), prior to allocation. During the active phase of the intervention, the responses to the 10 questions on the THI-S25 will be collected on a weekly basis. Data will then be collected at post-treatment (T1) and after the control group completes the intervention (T2). To determine long-term effectiveness of the intervention, data will again be collected 12 months (Tx) after the start of the intervention at the close out, and this will end the study.

The specific outcome measures for each collection point are shown in table 3. To improve rates at follow-up, an email will be sent to encourage participants to complete the questionnaires, with a maximum of three reminders. If they do not wish to further participate in the study, the reasons for their withdrawal will be recorded, where provided, by means of a post-treatment satisfaction questionnaire. All participants will receive a non-traceable unique reference code to keep their identities blinded during the result analysis. All files used will be password protected. The researchers, statisticians and internal data monitoring committee (DMC) will have access to the final data set. The DMC includes researchers who are independent to this study, without competing interests.

They will ensure accurate analysis and result interpretation.

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