Within- and between-person associations of time-varying determinants with snacking in older adults: an EMA study.

Promoting healthy snacking is important in addressing malnutrition, overweight and obesity among an ageing population. However, little is known about the factors underlying snacking behaviour in older adults. The present study aimed to explore within- and between-person associations between determinants (i.e. intention, visibility of snacks, social modelling and emotions) and snacking behaviours (i.e. decision to snack, health factor of the snack and portion size) in older adults (60+). Conducting a two-part intensive longitudinal design, data was analysed from 48 healthy older adults consisting of (1) an event-based self-report ecological momentary assessment (EMA) diary every time they had a snack and (2) a time-based EMA questionnaire on their phone 5 times per day. Analysis through generalised linear mixed models indicated that higher intention to snack healthily leads to healthier snacking while higher levels of social modelling and cheerfulness promote unhealthier choices within individuals. At the between-person level, similar results were found for intention and social modelling. Visibility of a snack increased portion size at both a within- and between-person level, while the intention to eat a healthy snack only increased portion size at the between-person level. No associations were found between the decision to snack and all determinants. This is the first study to investigate both within- and between-person associations between time-varying determinants and snacking in older adults. Such information holds the potential for incorporation into just-in-time adaptive interventions, allowing for personalised tailoring, more effective promotion of healthier snacking behaviours and thus, pursuing the challenge of healthy ageing.

Participatory development of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED).

BACKGROUND: The escalating global prevalence of type 2 diabetes and prediabetes presents a major public health challenge. Physical activity plays a critical role in managing (pre)diabetes; however, adherence to physical activity recommendations remains low. The ENERGISED trial was designed to address these challenges by integrating mHealth tools into the routine practice of general practitioners, aiming for a significant, scalable impact in (pre)diabetes patient care through increased physical activity and reduced sedentary behaviour. METHODS: The mHealth intervention for the ENERGISED trial was developed according to the mHealth development and evaluation framework, which includes the active participation of (pre)diabetes patients. This iterative process encompasses four sequential phases: (a) conceptualisation to identify key aspects of the intervention; (b) formative research including two focus groups with (pre)diabetes patients (n = 14) to tailor the intervention to the needs and preferences of the target population; (c) pre-testing using think-aloud patient interviews (n = 7) to optimise the intervention components; and (d) piloting (n = 10) to refine the intervention to its final form. RESULTS: The final intervention comprises six types of text messages, each embodying different behaviour change techniques. Some of the messages, such as those providing interim reviews of the patients' weekly step goal or feedback on their weekly performance, are delivered at fixed times of the week. Others are triggered just in time by specific physical behaviour events as detected by the Fitbit activity tracker: for example, prompts to increase walking pace are triggered after 5 min of continuous walking; and prompts to interrupt sitting following 30 min of uninterrupted sitting. For patients without a smartphone or reliable internet connection, the intervention is adapted to ensure inclusivity. Patients receive on average three to six messages per week for 12 months. During the first six months, the text messaging is supplemented with monthly phone counselling to enable personalisation of the intervention, assistance with technical issues, and enhancement of adherence. CONCLUSIONS: The participatory development of the ENERGISED mHealth intervention, incorporating just-in-time prompts, has the potential to significantly enhance the capacity of general practitioners for personalised behavioural counselling on physical activity in (pre)diabetes patients, with implications for broader applications in primary care.

Within-Person Associations of Accelerometer-Assessed Physical Activity With Time-Varying Determinants in Older Adults: Time-Based Ecological Momentary Assessment Study.

BACKGROUND: Despite the availability of physical activity (PA) interventions, many older adults are still not active enough. This might be partially explained by the often-limited effects of PA interventions. In general, health behavior change interventions often do not focus on contextual and time-varying determinants, which may limit their effectiveness. However, before the dynamic tailoring of interventions can be developed, one should know which time-dependent determinants are associated with PA and how strong these associations are. OBJECTIVE: The aim of this study was to examine within-person associations between multiple determinants of the capability, opportunity, motivation, and behavior framework assessed using Ecological Momentary Assessment (EMA) and accelerometer-assessed light PA, moderate to vigorous PA, and total PA performed at 15, 30, 60, and 120 minutes after the EMA trigger. METHODS: Observational data were collected from 64 healthy older adults (36/64, 56% men; mean age 72.1, SD 5.6 y). Participants were asked to answer a time-based EMA questionnaire 6 times per day that assessed emotions (ie, relaxation, satisfaction, irritation, and feeling down), the physical complaint fatigue, intention, intention, and self-efficacy. An Axivity AX3 was wrist worn to capture the participants' PA. Multilevel regression analyses in R were performed to examine these within-person associations. RESULTS: Irritation, feeling down, intention, and self-efficacy were positively associated with subsequent light PA or moderate to vigorous PA at 15, 30, 60, or 120 minutes after the trigger, whereas relaxation, satisfaction, and fatigue were negatively associated. CONCLUSIONS: Multiple associations were observed in this study. This knowledge in combination with the time dependency of the determinants is valuable information for future interventions so that suggestions to be active can be provided when the older adult is most receptive.

mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial.

BACKGROUND: The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. METHODS: We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. DISCUSSION: The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial's pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05351359, 28/04/2022).

The variability of emotions, physical complaints, intention, and self-efficacy: an ecological momentary assessment study in older adults.

Background: Many theoretical frameworks have been used in order to understand health behaviors such as physical activity, sufficient sleep, healthy eating habits, etc. In most research studies, determinants within these frameworks are assessed only once and thus are considered as stable over time, which leads to rather 'static' health behavior change interventions. However, in real-life, individual-level determinants probably vary over time (within days and from day to day), but currently, not much is known about these time-dependent fluctuations in determinants. In order to personalize health behavior change interventions in a more dynamic manner, such information is urgently needed. Objective: The purpose of this study was to explore the time-dependent variability of emotions, physical complaints, intention, and self-efficacy in older adults (65+) using Ecological Momentary Assessment (EMA). Methods: Observational data were collected in 64 healthy older adults (56.3% men; mean age 72.1 ± 5.6 years) using EMA. Participants answered questions regarding emotions (i.e., cheerfulness, relaxation, enthusiasm, satisfaction, insecurity, anxiousness, irritation, feeling down), physical complaints (i.e., fatigue, pain, dizziness, stiffness, shortness of breath), intention, and self-efficacy six times a day for seven consecutive days using a smartphone-based questionnaire. Generalized linear mixed models were used to assess the fluctuations of individual determinants within subjects and over days. Results: A low variability is present for the negative emotions (i.e., insecurity, anxiousness, irritation, feeling down) and physical complaints of dizziness and shortness of breath. The majority of the variance for relaxation, satisfaction, insecurity, anxiousness, irritation, feeling down, fatigue, dizziness, intention, and self-efficacy is explained by the within subjects and within days variance (42.9% to 65.8%). Hence, these determinants mainly differed within the same subject and within the same day. The between subjects variance explained the majority of the variance for cheerfulness, enthusiasm, pain, stiffness, and shortness of breath (50.2% to 67.3%). Hence, these determinants mainly differed between different subjects. Conclusions: This study reveals that multiple individual-level determinants are time-dependent, and are better considered as 'dynamic' or unstable behavior determinants. This study provides us with important insights concerning the development of dynamic health behavior change interventions, anticipating real-time dynamics of determinants instead of considering determinants as stable within individuals.

The association between Geographic Information System-based neighborhood built environmental factors and accelerometer-derived light-intensity physical activity across the lifespan: a cross-sectional study.

Background: Evidence on associations between environmental factors and accelerometer-derived light-intensity physical activity (LPA) is scarce. The aim of this study was to examine associations between Geographic Information System (GIS)-based neighborhood built environmental factors and accelerometer-derived LPA, and to investigate the moderating effect of age group (adolescents, adults, older adults) on these associations. Methods: Objective data were used from three similar observational studies conducted in Ghent (Belgium) between 2007 and 2015. Accelerometer data were collected from 1,652 participants during seven consecutive days, and GIS-based neighborhood built environmental factors (residential density, intersection density, park density, public transport density, entropy index) were calculated using sausage buffers of 500 m and 1,000 m around the home addresses of all participants. Linear mixed models were performed to estimate the associations. Results: A small but significant negative association was observed between residential density (500 m buffer) and LPA in the total sample (B = -0.002; SE = 0.0001; p = 0.04), demonstrating that every increase of 1,000 dwellings per surface buffer was associated with a two minute decrease in LPA. Intersection density, park density, public transport density and entropy index were not related to LPA, and moderating effects of age group were absent. Conclusions: The small association, in combination with other non-significant associations suggests that the neighborhood built environment, as classically measured in moderate-to-vigorous intensity physical activity research, is of limited importance for LPA. More research is needed to unravel how accelerometer-derived LPA is accumulated, and to gain insight into its determinants.

The impact of mental and somatic stressors on physical activity and sedentary behaviour in adults with type 2 diabetes mellitus: a diary study.

BACKGROUND: Adopting an active lifestyle is key in the management of type 2 diabetes mellitus (T2DM). Nevertheless, the majority of individuals with T2DM fails to do so. Additionally, individuals with T2DM are likely to experience mental (e.g., stress) and somatic (e.g., pain) stressors. Research investigating the link between these stressors and activity levels within this group is largely lacking. Therefore, current research aimed to investigate how daily fluctuations in mental and somatic stressors predict daily levels of physical activity (PA) and sedentary behaviour among adults with T2DM. METHODS: Individuals with T2DM (N = 54) were instructed to complete a morning diary assessing mental and somatic stressors and to wear an accelerometer for 10 consecutive days. The associations between the mental and somatic stressors and participants' levels of PA and sedentary behaviour were examined using (generalized) linear mixed effect models. RESULTS: Valid data were provided by 38 participants. We found no evidence that intra-individual increases in mental and somatic stressors detrimentally affected participants' activity levels. Similarly, levels of sedentary behaviour nor levels of PA were predicted by inter-individual differences in the mental and somatic stressors.

Age-related differences in the associations of physical environmental factors and psychosocial factors with accelerometer-assessed physical activity.

The aim of the current study was to examine age-related differences in the associations of physical environmental and psychosocial factors with accelerometer-assessed MVPA across three age groups (adolescents, adults, and older adults). Therefore, data from three studies with a comparable study protocol were combined. Results showed that both physical environmental factors and psychosocial factors were most strongly associated with MVPA in older adults. Consequently, health behavior interventions for older adults should focus on physical environmental factors as well as psychosocial factors. While adolescents and adults may benefit less from such interventions.

The occupational sitting and physical activity questionnaire (OSPAQ): a validation study with accelerometer-assessed measures.

BACKGROUND: The Occupational Sitting and Physical Activity Questionnaire (OSPAQ) was developed as an easy-to-use instrument for self-reported assessment of percentage sitting, standing, walking, and performing heavy labour in a workplace setting. This study aimed to evaluate the concurrent validity of all dimensions of the OSPAQ compared to accelerometer-assessed measures of occupational physical activities in a mixed sample of sedentary and physically active professions. METHODS: Data from the Flemish Employees' Physical Activity (FEPA) study were used, including employees from the service and production sector. All participants filled in a questionnaire, underwent clinical measurements, and wore two Axivity AX3 accelerometers for at least 2 consecutive working days. Intraclass (ICC) and Spearman rho correlations (r) were analyzed to assess concurrent validity. RESULTS: The sample included 401 workers (16% sedentary profession) with a mean age of 39.2 (± 11) years. Concurrent validity was good and moderate for assessing percentage of sitting (ICC = 0.84; r = 0.53), and standing (ICC = 0.64; r = 0.53), respectively. The concurrent validity for walking was weak to moderate (ICC = 0.50; r = 0.49), and weak for performing heavy labour (ICC = 0.28; r = 0.35). Stronger validity scores were found in sedentary professions for occupational sitting and standing. In physically active professions, an underestimation of self-reported sitting and standing was found, and an overestimation of self-reported walking and heavy labour. No significant self-reported over- or underestimation was found for sitting and heavy labour in sedentary professions, but an underestimation of self-reported standing and an overestimation of self-reported walking was observed. CONCLUSIONS: The OSPAQ has acceptable measurement properties for assessing occupational sitting and standing. Accelerometer-assessed measures of occupational walking and heavy labour are recommended, since a poor concurrent validity was found for both.

Measuring health-related quality of life by experiences: the experience sampling method.

OBJECTIVE: To explore the potential value of obtaining momentary, instead of retrospective, accounts of the description and valuation of a person's own health-related quality of life (HRQOL). METHODS: Momentary HRQOL was examined with the experience sampling method (ESM) in 139 participants from four different samples. The ESM consists of a so-called beep questionnaire that was administered 10 times a day by an electronic device. Feasibility was determined by assessing willingness to participate in the study and by analyzing the percentage of dropouts and the number of completed beep questionnaires. Multilevel analysis was used to investigate the relation between momentary HRQOL and momentary feelings and symptoms. The relation between momentary outcomes and the EuroQol visual analogue scale was investigated with a multiple regression model. RESULTS: The overall participation rate was low, but there were no dropouts and the number of completed beeps was comparable to that in other studies. Multilevel analysis showed that feelings and symptoms were significant predictors of momentary HRQOL. The strength of these relations differed among three patient groups and a population-based sample. The EuroQol visual analogue scale was not predicted by momentary feelings and symptoms. CONCLUSIONS: We can conclude that the use of the ESM to measure accounts of the momentary experience of health in different populations is feasible. Retrospective measures may provide a biased account of the impact of health problems in the daily lives of people who are affected. Moreover, the bias may be different in different conditions.

Cost-effectiveness of specialized treatment based on cognitive behavioral therapy versus usual care for tinnitus.

OBJECTIVE: To evaluate the cost-effectiveness of specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy, compared with care as usual. DESIGN: Randomized controlled trial including an economic evaluation from a health-care and societal perspective, using a one-year time horizon. SETTING: Audiologic center. PATIENTS: A referred sample of 626 patients with tinnitus were eligible for participation. Approximately 492 patients were included in the study. Eighty-six (35%) of 247 patients in the usual care group, and 74 (30%) of 245 patients in the specialized care group were lost to follow-up by month 12. MAIN OUTCOME MEASURES: Quality adjusted life years (QALYs) as measured with the Health Utilities Index Mark III and cost in US dollars. RESULTS: Compared with patients receiving usual care, patients who received specialized care gained on average 0.015 QALYs (95% bootstrapped confidence interval [BCI], -0.03 to 0.06). The incremental costs from a societal perspective are $357 (95% BCI,-$1,034 to $1,785). The incremental cost per QALY from a societal perspective amounted to $24,580. The probability that SC is cost-effective from a societal perspective is 58% for a willingness to pay for a QALY of $45,000. CONCLUSION: Specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy is cost-effective as compared with usual care. Although uncertainty surrounding the incremental costs and effects is considerable, sensitivity analysis indicated that cost-effectiveness results were robust.

Tinnitus: a cost study.

OBJECTIVES: The aim of this study was to examine the costs of tinnitus in The Netherlands from a health care and a societal perspective. Furthermore, the impact of disease characteristics and demographic characteristics on these costs were examined. METHODS: A bottom-up cost of illness study was performed, using the baseline data on a cost questionnaire of a randomized controlled trial investigating the (cost) effectiveness of an integral multidisciplinary treatment for tinnitus versus care as usual. Mean yearly costs were multiplied by the prevalence figure of tinnitus for the adult general population to estimate the total cost of illness of tinnitus to society. Because cost data usually are not normally distributed, a nonparametric bootstrap resampling procedure with 1000 simulations was performed to determine statistical uncertainty of the cost estimates per category. Several questionnaires measuring disease and demographic characteristics were administered. The impact of disease characteristics and demographics on costs was investigated using a multivariate regression analysis. RESULTS: Total mean societal cost of illness was €6.8 billion (95% confidence interval: €3.9 billion-€10.8 billion). The larger part of total cost of illness was not related to health care. Total mean health care costs were €1.9 billion (95% confidence interval: €1.4 billion-€2.5 billion). Significant predictors of both health care costs and societal costs were tinnitus severity, age, shorter duration of tinnitus, and more severe depression. CONCLUSION: The economical burden of tinnitus to society is substantial, and severity of tinnitus is an important predictor of the costs made by patients.

Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial.

BACKGROUND: Up to 21% of adults will develop tinnitus, which is one of the most distressing and debilitating audiological problems. The absence of medical cures and standardised practice can lead to costly and prolonged treatment. We aimed to assess effectiveness of a stepped-care approach, based on cognitive behaviour therapy, compared with usual care in patients with varying tinnitus severity. METHODS: In this randomised controlled trial, undertaken at the Adelante Department of Audiology and Communication (Hoensbroek, Netherlands), we enrolled previously untreated Dutch speakers (aged >18 years) who had a primary complaint of tinnitus but no health issues precluding participation. An independent research assistant randomly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio, stratified by tinnitus severity and hearing ability, in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care. Patients and assessors were masked to treatment assignment. Primary outcomes were health-related quality of life (assessed by the health utilities index score), tinnitus severity (tinnitus questionnaire score), and tinnitus impairment (tinnitus handicap inventory score), which were assessed before treatment and at 3 months, 8 months, and 12 months after randomisation. We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00733044. FINDINGS: Between September, 2007 and January, 2011, we enrolled and treated 492 (66%) of 741 screened patients. Compared with 247 patients assigned to usual care, 245 patients assigned to specialised care improved in health-related quality of life during a period of 12 months (between-group difference 0·059, 95% CI 0·025 to 0·094; effect size of Cohen's d=0·24; p=0·0009), and had decreased tinnitus severity (-8·062, -10·829 to -5·295; d=0·43; p<0·0001) and tinnitus impairment (-7·506, -10·661 to -4·352; d=0·45; p<0·0001). Treatment seemed effective irrespective of initial tinnitus severity, and we noted no adverse events in this trial. INTERPRETATION: Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW).

Tinnitus interferes with daily life activities: a psychometric examination of the Tinnitus Disability Index.

OBJECTIVES: Tinnitus Disability Index (TDI) is presented as a novel and brief self-report measure for the assessment of the interference of tinnitus with performance in specific daily life activities. We hypothesized that the TDI is a reliable and valid measure and that tinnitus disability is strongly associated with tinnitus severity, subjective tinnitus intensity ratings, and ratings of general health. DESIGN: Six hundred fifteen tinnitus patients from across the Netherlands completed online a number of questionnaires about their tinnitus, their general health, and demographics. Two samples were extracted by a random split: Sample I (N = 311) for exploratory factor analysis and Sample II (N = 304) for confirmatory analysis, using structural equation modeling. One hundred forty-three of the first included respondents repeated assessment after a 2-wk time interval for test/retest analysis. Regression analyses were employed to investigate construct validity. RESULTS: Present analyses reveal that tinnitus disability, as measured with the TDI, might be best understood as a single-component construct, that is, one single underlying factor. The TDI is reliable over time, and tinnitus-related disability, as measured with the TDI, is strongly associated with subjective ratings of tinnitus intensity, negatively associated with quality of life ratings, and distress due to tinnitus. CONCLUSIONS: The TDI is a brief and easily administered index measuring a unique construct, namely the experienced interference of the tinnitus with daily life activities, which is invaluable in the assessment and treatment of tinnitus patients.

Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III.

OBJECTIVES: Expressing the outcomes of treatment in quality-adjusted life years is increasingly important as a tool to aid decision makers concerning the allocation of scarce resources within the health care sector. A quality-adjusted life year is a measure of life expectancy that is weighted by health-related quality of life. These weights are referred to as utility scores and are usually measured by multiattribute utility measures. Several studies found that different utility measures provide different estimates of the same person's level of utility. The aim of this study was to investigate which of two widely used utility measures, the EQ-5D and the HUI mark III, is preferred in a tinnitus population. METHODS: Baseline and follow-up data on EQ-5D and HUI mark III of 429 patients of a randomized controlled clinical trial, investigating cost-effectiveness of usual care versus specialized care of tinnitus, were included. Agreement, discriminative power, and responsiveness of the health state description and the utility scores were examined. RESULTS: Corresponding dimensions of the EQ-5D and HUI mark III showed large correlations; although ceiling effects were more frequently observed in the EQ-5D. Mean utility scores for EQ-5D (0.77; SD 0.22) and HUI mark III (0.64; SD 0.28) were significantly different (Wilcoxon signed ranks test, p < 0.001), and agreement was low to moderate (intraclass correlation coefficient = 0.53). Both health state description and utility scores of both measures discriminated between different severity groups. These groups were based on baseline scores of the Tinnitus Questionnaire. The HUI mark III had a higher ability than the EQ-5D to detect improved patients from randomly selected pairs of improved and unimproved patients. CONCLUSION: This study shows that different utility measures lead to different health state descriptions and utility scores among tinnitus patients. However, both measures are capable of discriminating between clinically different groups. The HUI mark III is more responsive than the EQ-5D, and therefore preferred in a tinnitus population.

Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre.

BACKGROUND: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol. METHODS/DESIGN: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective. DISCUSSION: This is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated. TRIAL REGISTRATION: The trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044.