Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial.

May combine two claims.

Internet-based cognitive behavioural therapy for tinnitus has demonstrated efficacy in nine randomized controlled trials in Europe, with moderate effect sizes for tinnitus distress and insomnia and improvements in anxiety, depression, and quality of life.

“Its efficacy has been demonstrated in nine randomized controlled trials (RCTs) in Europe indicating a moderate effect size for both tinnitus distress and insomnia and improvements for anxiety, depression, and quality of life (Beukes et al., 2019).”

• cites Beukes et al., 2019 sourcePartly supported

  Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

Public attitudes toward internet interventions are variable and acceptability can be obscured by misinformation regarding their effectiveness.

“Public attitudes toward internet interventions are variable and acceptability of such interventions can be obscured by misinformation regarding their effectiveness (Apolinário-Hagen et al., 2018).”

• cites Apolinário-Hagen et al., 2018 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

The Transparent Reporting of Evaluations with Nonrandomized Designs checklist was used to ensure best practice.

“To ensure that best practice was followed, the Transparent Reporting of Evaluations with Nonrandomized Designs checklist (Des Jarlais, Lyles, Crepaz, & Trend Group, 2004) was used.”

• cites Des Jarlais, Lyles, Crepaz, & Trend Group, 2004 sourceSupported

May combine two claims.

Intervention completion rates are lower than past trials ranging between 57-95%, but similar to recent trials.

“Intervention completion rates are lower than past trials ranging between 57–95% (Beukes et al., 2019), but these lower rates are similar to recent trials (Beukes et al., 2021c, 2021d, 2021e).”

• cites Beukes et al., 2019 sourceCould not verify

  The Results > Study Characteristics section reports postintervention attrition of 4%–75%, not intervention completion rates of 57%–95%. I searched for the stated range and for intervention completion or adherence, but found no passage in our copy establishing that range. The comparison with recent trials is attributed to the separate 2021 citations, not this source. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites Beukes et al., 2021cNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Beukes et al., 2021dNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Limited uptake of the intervention by Spanish-speaking communities was surprising, with unclear reasons.

“Asurprising result was the limited uptake of this intervention by the Spanish-speaking communities, although the reasons for this are unclear.”

May combine two claims.

During recruitment, the Spanish pages were viewed by 285 Spanish speakers, with an average view duration of 2 minutes and an average of 3 of 8 recruitment pages viewed.

“During the recruitment period, the Spanish pages were viewed by 285 Spanish speakers. The views lasted for an average of 2 minutes with an average of 3 of the 8 recruitment pages being viewed.”

May combine two claims.

Although the recruitment target was reached, recruiting Spanish speakers was difficult and required numerous campaigns.

“Although the recruitment target was reached, recruiting Spanish speakers was difficult and it required numerous campaigns, including contracting a company to boost recruitment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Forty-six Spanish-speakers with tinnitus were screened.

“46 Spanish-speakers with tinnitus were screened.”

May combine two claims.

Clinically significant change was obtained by 14/32 (44%) at both T1 and T2 for imputation data and by 8/22 (36%) at T1 and 6/16 (50%) at T2 for completers-only data.

“This was obtained by 14/32 (44%) at both T1 and T2 for the imputation data and 8/22 (36%) at T1 and 6/16 (50%) at T2 for the completers only data .”

May combine two claims.

Overall, there was a weekly reduction in tinnitus distress (THI-S) and tinnitus qualities (TQQ).

“Overall, there was a weekly reduction in tinnitus distress (THI-S) and tinnitus qualities (TQQ), as seen in Figure 3.”

May combine two claims.

All participants logged in at least once and completed at least one worksheet.

“All participants logged in at least once and completed at least 1 worksheet.”

May combine two claims.

Of the 46 screened, 3 did not meet inclusion criteria due to low TFI scores and 11 were unable to do the intervention during the given timeframe.

“Of these, 3 did not meet the inclusion criteria due to low scores on the TFI (below 25/100) and 11 were unable to do the intervention during the given timeframe (Figure 1).”

May combine two claims.

Only 44% of participants indicated clinically significant changes at post-intervention, similar to 38% in a UK pilot but lower than 70% in a US pilot.

“In the current sample, only 44% of participants indicated clinically significant changes at post-intervention, which is similar to the 38% for a pilot study in the UK (Beukes et al., 2017) but lower than that of a recent pilot trial in the US of 70% (Beukes et al., 2021c).”

• cites Beukes et al., 2017Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Beukes et al., 2021cNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Some participants mentioned finding new techniques helpful and learning a lot from the online program.

“Some participants mentioned finding the new techniques helpful saying: “I’ve learned new techniques of relaxation, to breathe and decrease tension I was carrying around,” and learning a lot from the program although it was online: “you learn the same as if one had the professor in front of you teaching you, at least in my case, I took it as a course just like the ones I do in my profession.”

May combine two claims.

The majority of participants lived in Spain (69%) and the remainder lived in South America (31%).

“The majority lived in Spain (69%), while the others (31%) were living in South America.”

May combine two claims.

The weekly reduction was significant for TQQ [F(7,7.80)=3.45, p=.002*], but not for THI-S [F(7,63.33)=2.16, p=.05*].

“This reduction was only significant for the TQQ [F(7,7.80) = 3.45, p = .002*], but not for the THI-S [F(7,63.33) = 2.16, p = .05*].”

May combine two claims.

Participants reported that the intervention helped them better manage tinnitus and control their mood.

“When answering the open-ended question, participants explained that the intervention has helped them better manage the tinnitus saying: “I’ve learned to deal with the tinnitus and control it. It has less of an impact on my life now as I am more capable of managing it,” and gain other perspectives with statements such as “I see situations differently now and it has helped me control my mood.””

May combine two claims.

Module 1 was opened by 31 (97%) participants, while the optional listening tips module was opened by 12 (38%).

“Module 1 was opened by 31 (97%) participants whereas the later modules were opened by fewer participants, with the lowest for the optional module on listening tips opened by 12 (38%) of the participants (Figure 2).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The mean age of participants was 47 years with a standard deviation of 11 years.

“with a mean age of 47 (± 11) years.”

May combine two claims.

Overall, participants were satisfied with the intervention, although the rating of 68% is lower than reported for similar interventions (e.g., 86% in a UK pilot).

“Overall, participants were satisfied with the intervention, although the rating of 68% is lower than reported for similar interventions (e.g., 86% for a pilot trial in the UK, Beukes et al., 2017, 2018d).”

• cites Beukes et al., 2017Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Beukes et al., 2018dNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

No participants withdrew during the study.

“No participants withdrew during the study.”

Classified as probably not a substantial claim.

Internet-based cognitive behavioural therapy has improved access to cognitive behavioural therapy for various psychiatric and somatic disorders, including tinnitus.

“internet based cognitive behavioral therapy (ICBT) has improved access to cognitive behavioral therapy (CBT) for a range of psychiatric and somatic disorders, including tinnitus (Andersson et al., 2019).”

• cites Andersson et al., 2019 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Tinnitus is often associated with additional difficulties such as insomnia, anxiety, and depression.

“Tinnitus is often associated with additional difficulties such as insomnia, anxiety, and depression (Salazar et al., 2018).”

• cites Salazar et al., 2018Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

Spanish translations of all outcome measures were used.

“Spanish translations (Manchaiah et al., 2020a) of all outcome measures were used as shown in Table 1.”

• cites Manchaiah et al., 2020aNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Missing data were handled through multiple imputation using the Markov Chain Monte Carlo approach.

“Initially missing data were handled through multiple imputation using the Markov Chain Monte Carlo approach due to a non-significant result for the assumption of missing data Little’s MCAR test (X2 = 17.50 (24) = .83).”

• AssumptionThe authors state this as an assumption: The missing data were completely missing at random.

May combine two claims.

The post-intervention completion rate was 69% (n=22) and the follow-up completion rate was 50% (n=16).

“The number of participants completing the outcome measures were reduced as the trial progressed with a post-intervention completion rate of 69% (n=22) and follow-up completion rate of 50% (n=16) as seen in Figure 1.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Ethical approval was obtained from the Institutional Review Board at Lamar University, Beaumont, Texas, USA.

“Ethical approval was obtained from the Institutional Review Board at Lamar University, Beaumont, Texas, USA (IRB-FY20–200).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study protocol was pre-registered at ClinicalTrials.gov with identifier NCT04335929.

“The study protocol was pre-registered at ClinicalTrials.gov (NCT04335929).”

Classified as probably not a substantial claim.

Internet-based cognitive behavioural therapy is a means of accessing evidence-based interventions.

“ICBT is a means of accessing evidence-based interventions, and the COVID-19 pandemic has furthermore highlighted the need for evidence-based eHealth approaches to overcome limited in-person contact and support available for individuals with tinnitus (Beukes et al., 2020b, 2021b).”

• cites Beukes et al., 2020bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Beukes et al., 2021bNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

A completer-only analysis was performed as a sensitivity analysis.

“As this cannot be ascertained due to the large amount of missing data, a completer’s only analysis was also done as a sensitivity analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Placebo effects may be present and could elevate the findings.

“Furthermore, placebo effects may be present which could elevate findings and need to be considered during result interpretation.”

May combine two claims.

Intervention engagement and compliance were not optimal although no participants withdrew.

“Intervention engagement and compliance were not optimal although no participants withdrew.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Spanish is spoken by approximately 580 million people globally and is the largest non-English language spoken in the United States.

“Spanish is spoken by approximately 580 million people across the globe and is the largest non-English language spoken in the US according to the 2017 census (US Census Bureau, 2017).”

• cites US Census Bureau, 2017Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Linear mixed models were used to account for repeated measures and incorporate all available data points.

“Finally, linear mixed models (LMM) using maximum likelihood with random intercept for participants were used to account for repeated measures and incorporate all available data points in the analysis.”

May combine two claims.

The results were not intended to evaluate the efficacy of internet-based cognitive behavioural therapy because no control group was included and only a small sample was studied.

“The results were not intended to evaluate the efficacy of ICBT as no control group was included and only a small sample was studied.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The reliable change index was used to calculate clinical significance of changes on the Tinnitus Functional Index.

“The reliable change index (RCI) (Jacobson & Truax, 1991) was used as a means of calculating clinical significance of the changes on the TFI.”

• cites Jacobson & Truax, 1991 sourceNot checked — no full text of the source