scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

scholarly journals Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients with Aphasia: Protocol for a Virtual Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Esther Kim ◽  
Laura Laird ◽  
Carlee Wilson ◽  
Till Bieg ◽  
Phillip Mildner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Lexical Retrieval ◽  
Evidence Based ◽  
Waitlist Control ◽  
Treatment Assessment ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mobile application-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia (PwA) as an adjunct or in lieu of traditional in-person therapy approaches. These apps can increase the intensity of treatment, and have been shown to result in meaningful outcomes across several domains OBJECTIVE VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to engage PwA to improve their naming abilities through interaction with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. METHODS A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. Intervention group participants will engage in five weeks of training with the app, followed by post-treatment assessment and follow-up assessment after an additional five weeks. Those in the waitlist control group will have five weeks of no training, followed by a pre-treatment assessment, training for five weeks and post-treatment assessment. All aspects of the trial are being conducted remotely given the COVID-19 pandemic. RESULTS Recruitment of participants started in September 2020 and the study is expected to be completed by March 2022. Publication of results is expected within six months of study completion. CONCLUSIONS Results of the RCT will provide data to inform evidence-based practice on the use of technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in PwA within an easily accessible, cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can inform the profession on telerehabilitation practices and monitoring app-based home therapy programs. CLINICALTRIAL ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

scholarly journals Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial

2020 ◽  
Vol 15 (2) ◽  
pp. 164-169
Author(s):  
Fatemeh Abbasalizadeh ◽  
Khadijeh Pouya ◽  
Raana Zakeri ◽  
Rana Asgari-Arbat ◽  
Shamsi Abbasalizadeh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Premature Infants ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Control Group ◽  
Randomized Controlled ◽  
Neonatal Respiratory Distress ◽  
And Control

Background: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. Objective: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. Method: 140 women with a multifetal pregnancy at less than 28 weeks’ gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. Result: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. Conclusion: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

scholarly journals Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3373-3378 ◽  
Author(s):  
Hamideh Abbaspour Kasgari ◽  
Siavash Moradi ◽  
Amir Mohammad Shabani ◽  
Farhang Babamahmoodi ◽  
Ali Reza Davoudi Badabi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Single Centre ◽  
Mazandaran Province ◽  
Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

scholarly journals Breastfeeding success with the use of the inverted syringe technique for management of inverted nipples in lactating women: a study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mona Nabulsi ◽  
Rayan Ghanem ◽  
Marlie Abou-Jaoude ◽  
Ali Khalil
Keyword(s):  
Randomized Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Standard Care ◽  
Infant Nutrition ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Inverted Nipples

Abstract Background Breastfeeding provides ideal infant nutrition, conferring several health benefits to children and their mothers. Women with inverted nipples, however, face difficulties that force them to prematurely terminate breastfeeding. Whereas available conservative measures for the correction of inverted nipples are of limited success, the use of an inverted syringe may be effective in achieving high rates of infant latching and exclusive breastfeeding. This technique, however, has not been investigated in a clinical trial. Methods/design This open-label randomized controlled trial aims to investigate whether, in women with inverted nipples, the use of an inverted syringe increases the rate of exclusive breastfeeding at one month compared to standard care. One-hundred healthy women with grade 1 or 2 inverted nipples will be recruited as of 37 weeks of gestation. They will be randomly allocated to standard care (control group) or to an intervention group. The intervention consists of using an inverted syringe to evert the nipple before every breastfeed, starting with the first feed after delivery. The primary outcome measure is the rate of exclusive breastfeeding at 1 month. Secondary outcome measures include exclusive breastfeeding rates at 3 and 6 months, nipple eversion rate, successful latching rate, rates of any breastfeeding at 1, 3, and 6 months, breastfeeding-associated complications, maternal satisfaction with breastfeeding, maternal quality of life, and adverse events. Descriptive and regression analysis will be conducted under the intention to treat basis. Discussion The use of the inverted syringe to evert inverted nipples is a simple, inexpensive, and safe technique that can be performed by mothers with inverted nipples. Findings of this trial, if positive, will provide much needed evidence for a safe, affordable, readily available, and simple intervention to treat inverted nipples, and improve breastfeeding practice among affected women. Trial registration ClinicalTrials.gov, NCT03529630. Registered May 8, 2018.

scholarly journals A Mediterranean Dietary Intervention in Female Carriers of BRCA Mutations: Results from an Italian Prospective Randomized Controlled Trial

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3732
Author(s):  
Eleonora Bruno ◽  
Andreina Oliverio ◽  
Angelo Virgilio Paradiso ◽  
Antonella Daniele ◽  
Stefania Tommasi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Levels ◽  
Protein Restriction ◽  
Control Group ◽  
Brca Mutations ◽  
Randomized Controlled ◽  
Igf I

Background: Women carriers of BRCA1/2 mutations face a high lifetime risk (penetrance) of developing breast and/or ovarian cancer. Insulin-like growth factor I (IGF-I), body weight and markers of insulin resistance affect BRCA penetrance. We conducted a multicenter prospective two-armed (1:1) randomized controlled trial (NCT03066856) to investigate whether a Mediterranean dietary intervention with moderate protein restriction reduces IGF-I and other metabolic modulators of BRCA penetrance. Methods: BRCA carriers, with or without a previous cancer, aged 18–70 years and without metastases were randomly assigned to an active dietary intervention group (IG) or to a control group (CG). The primary endpoint of the intervention was the IGF-I reduction. Results: 416 women (216 in the IG and 200 in the CG) concluded the six-month dietary intervention. The IG showed significantly lowered serum levels of IGF-I (−11.3 ng/mL versus −1.3 ng/mL, p = 0.02), weight (−1.5 Kg versus −0.5 Kg, p < 0.001), waist circumference (−2 cm versus −0.7 cm, p = 0.01), hip circumference (−1.6 cm versus −0.5 cm, p = 0.01), total cholesterol (−10.2 mg/dL versus −3.6 mg/dL, p = 0.04) and triglycerides (−8.7 mg/dL versus + 5.5 mg/dL, p = 0.01) with respect to the CG. Conclusions: A Mediterranean dietary intervention with moderate protein restriction is effective in reducing IGF-I and other potential modulators of BRCA penetrance.

scholarly journals Assessing Validity of Self-Reported Dietary Intake within a Mediterranean Diet Cluster Randomized Controlled Trial among US Firefighters

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2250 ◽  
Author(s):  
Mercedes Sotos-Prieto ◽  
Costas Christophi ◽  
Alicen Black ◽  
Jeremy D Furtado ◽  
Yiqing Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Dietary Intake ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Omega 3 ◽  
Randomized Controlled ◽  
Cluster Randomized

Collecting dietary intake data is associated with challenges due to the subjective nature of self–administered instruments. Biomarkers may objectively estimate the consumption of specific dietary items or help assess compliance in dietary intervention studies. Our aim was to use a panel of plasma and urine biomarkers to assess the validity of self-reported dietary intake using a modified Mediterranean Diet Scale (mMDS) among firefighters participating in Feeding America’s Bravest (FAB), an MD cluster-randomized controlled trial. In our nested biomarker pilot study, participants were randomly selected from both the MD intervention group (n = 24) and the control group (n = 24) after 12-months of dietary intervention. At baseline data collection for the pilot study (t = 12-months of FAB), participants in the control group crossed-over to receive the MD intervention (active intervention) for 6-months. Participants in the intervention group continued in a self-sustained continuation phase (SSP) of the intervention. Food frequency questionnaires (FFQ), 13-item-mMDS questionnaires, 40 plasma fatty acids, inflammatory biomarkers and urinary hydroxytyrosol and tyrosol were analyzed at both time points. Spearman’s correlation, t-tests and linear regression coefficients were calculated using SAS software. Overall, the mMDS derived from the FFQ was highly correlated with the specific 13-domain-mMDS (r = 0.74). The concordance between the two questionnaires for low and high adherence to MD was high for all the participants in the parent trial (κ = 0.76). After 6 months of intervention in the pilot study, plasma saturated fatty acid decreased in both groups (active intervention: −1.3 ± 1.7; p = 0.002; SSP: −1.12 ± 1.90; p = 0.014) and oleic acid improved in the SSP (p = 0.013). Intake of olive oil was positively associated with plasma omega-3 (p = 0.004) and negatively with TNF-α (p < 0.001) at baseline. Choosing olive oil as a type of fat was also associated with higher levels of plasma omega-3 (p = 0.019) at baseline and lower TNF-α (p = 0.023) at follow up. Intake of red and processed meats were associated with lower serum omega-3 (p = 0.04) and fish consumption was associated with lower IL-6 at baseline (p = 0.022). The overall mMDS was associated with an increase in plasma omega-3 (p = 0.021). Good correlation was found between nutrient intake from the FFQ and the corresponding plasma biomarkers (omega-3, EPA and DHA). In this MD randomized controlled trial, some key plasma biomarkers were significantly associated with key MD diet components and the overall mMDS supporting the validity of the mMDS questionnaire as well as compliance with the intervention.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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