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Cited by 25Sleep and related disordersMindfulness and Compassion InterventionsDigital Mental Health Interventions

Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training.

Open access
Gao, May, Roy, Alexandra, Deluty, Alana, Sharkey, Katherine M., Hoge, Elizabeth A., Liu, Tao, Brewer, Judson A.·2022·Psychosomatic Medicine
DOI 10.1097/psy.0000000000001083PMC PMC9167766
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Abstract

Objective: Sleep disturbance is experienced by nearly 20% of Americans and is highly comorbid with anxiety. Sleep disturbances may predict the development of anxiety disorders. Mindfulness training (MT) has shown efficacy for anxiety yet remains limited by in-person-based delivery. Digitally delivered MT may target habitual worry processes, yet its effects on sleep have not been studied. This study tested if app-based MT for anxiety could reduce worry and improve sleep and examined the underlying mechanisms. Methods: Individuals reporting worry interfering with sleep were randomized to treatment as usual (TAU; n = 40) or TAU + app-based MT (n = 40). Treatment-related changes in worry-related sleep disturbances (WRSDs), worry, nonreactivity, and anxiety were evaluated via self-report questionnaires at 1 and 2 months after treatment initiation. Fitbit devices were used to record total sleep time and estimate sleep efficiency. At 2 months, TAU received access to app-based MT, and both groups were reassessed at 4 months. Results: In a modified intent-to-treat analysis, WRSD scores decreased by 27% in TAU + MT (n = 36) and 6% in TAU (n = 35) at 2 months (median [IQR] change = 11 [4.3] versus 15 [5.0], p = .001). These WRSD reductions were mediated by decreased worry, particularly improved nonreactivity (p values < .001). At 4 months, TAU reported a significant 29% reduction after beginning app-based MT at 2 months and TAU + MT maintained its gains. No significant between-group differences in average estimated total sleep time or sleep efficiency were found after 2 months of using the app. Conclusions: Few mindfulness-related apps have been evaluated for clinical efficacy and/or mechanism. Results from this study demonstrate a mechanistic link between MT and increased emotional nonreactivity, decreased worry, and reduction in reported sleep disturbances, suggesting that app-based MT may be a viable option to help individuals who report that worry interferes with their sleep. Trial Registration: ClinicalTrials.gov identifier: NCT03684057.

AI snapshot

Written from the paper’s full text.

TL;DR

In adults reporting worry that interfered with sleep, adding an app-based mindfulness program to usual care reduced worry-related sleep disturbance, worry, and anxiety more than usual care alone over two months, with gains maintained and reproduced when controls later received the app. Mediation analyses suggested increased emotional non-reactivity lowered worry, which in turn lowered perceived sleep disturbance, while device-estimated sleep duration and efficiency did not differ between groups.

Key findings

  • At 2 months, worry-related sleep disturbance fell by 27% with TAU+MT versus 6% with TAU; PROMIS scores dropped from 16.5 to 11.0 versus 16.0 to 15.0 (P = .001). After TAU received the app at 2 months, it showed a 29% reduction by 4 months, while TAU+MT maintained its gains.
  • Worry decreased by 12% in TAU+MT versus 0.3% in TAU (PSWQ: 62.3 to 54.6 vs. 62.3 to 61.7, P < .001); non-reactivity increased by 27% versus 4% (P < .001); anxiety showed a median 37% reduction versus a 17% increase (GAD-7: 12.0 to 6.5 vs. 10.0 to 11.0, P = .002).
  • Mediation models indicated that increased non-reactivity at 2 months mediated the effect of MT on reduced worry (indirect β = −0.43, 95% CI −0.77 to −0.18, P < .001; 49% of the effect), and reduced worry fully mediated the effect on WRSD (indirect β = −0.39, 95% CI −0.69 to −0.15, P < .001; 53% of the effect).
  • No significant between-group differences appeared in Fitbit-estimated total sleep time or sleep efficiency at 2 months (P = .52; P = .70), or in sleep-diary sleep period time (P = .75).

Methods

  • Parallel-group randomized controlled trial: 80 adults with elevated worry and self-reported worry-related sleep trouble were randomized 1:1 to TAU (n = 40) or TAU plus app-based MT (n = 40); 71 entered the modified intent-to-treat analysis (TAU+MT n = 36; TAU n = 35).
  • The intervention was the Unwinding Anxiety app: 30 core modules plus 8 theme weeks, brief daily videos/animations, ecological momentary assessment tools, guided meditations, and short on-demand exercises; the program lasted 2 months, with assessments at baseline, 1, 2, and 4 months, and TAU receiving app access after the 2-month assessment.
  • Primary outcome was WRSD from five PROMIS sleep disturbance items; secondary outcomes included PSWQ worry, FFMQ non-reactivity, GAD-7 anxiety, Fitbit TST/SE, and paper sleep diaries. Analyses used intent-to-treat and complete-case approaches, GEE models, multiple imputation, and Baron-and-Kenny plus causal mediation models with bootstrapping.

Limitations

  • Stated: the commercial Fitbit has accuracy and precision limits, tends to overestimate total sleep time and underestimate restlessness, and the study did not clinically evaluate insomnia, so findings may not generalize to chronic insomnia; the PROMIS items focus on worry at bedtime and difficulty falling asleep, leaving sleep onset latency, awakenings, and wake after sleep onset for future work.
  • Stated: the trial lacked an active control matched for cognitive effort, and future research should compare digital CBT-I with digital MT because they target sleep-related worry and behavior through different mechanisms.
  • Evident from the text: baseline Fitbit sleep efficiency was already 96% in both groups, suggesting a ceiling effect; missing data were substantial (about 30% for Fitbit wear periods and 9.3% for sleep diaries), and engagement was incomplete (53% of TAU+MT completed 30 modules at 2 months, rising to 73% at 4 months; 34% of TAU completed the program by 4 months).

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1097/psy.0000000000001083

Cites

48 of 48 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

15 of 45 cited sources checked · 9 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Mindfulness-based Stress Reduction is a promising intervention to mitigate anxiety.

    “Mindfulness-based Stress Reduction (MBSR), is a promising intervention to mitigate anxiety (9).”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    The effects of mindfulness training on anxiety were mediated by decreased worry.

    “Furthermore, the effects of MT on anxiety were mediated by decreased worry.”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    Improving the ability to maintain emotional non-attachment from unfavorable sleep outcomes through mindfulness practice addresses the metacognitive component of sleep-related arousal.

    “Improving one’s ability to maintain emotional non-attachment from unfavorable sleep outcomes through mindfulness practice addresses the metacognitive component of sleep-related arousal (11,13,14).”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [11] source
    • cites [13] source

      The Secondary outcomes discussion says mindfulness may promote cognitive deactivation by helping people disengage from concerns and relate to sleep-related thoughts with letting go and acceptance. The Changes in study outcomes section also reports reduced cognitive pre-sleep arousal with the mindfulness app. Neither passage specifically establishes emotional non-attachment from unfavorable sleep outcomes as the mechanism or identifies a metacognitive component of arousal. (LLM, conf=0.82)

      Experimental — accuracy not yet measured
    • cites [14] source
  • Premisecitation

    Developing metacognitive awareness may help individuals notice body sensations and hyperarousal without worsening inability to sleep due to frustration.

    “Developing metacognitive awareness may help individuals to notice body sensations and hyperarousal without exacerbating the inability to sleep due to frustration (11).”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    Persistent sleep disturbance predicts the later development of anxiety disorders.

    “persistent sleep disturbance predicts the development of anxiety disorders (2,3)”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [2] source
    • cites [3] source
  • Classified as probably not a substantial claim. 24
  • May combine two claims. 33

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

    Study design and conductcitation

    The Generalized Anxiety Disorder-7 is a validated 7-item questionnaire with sensitivity 89% and specificity 82% for screening generalized anxiety disorder and assessing symptom severity.

    “The GAD-7 is a validated 7-item questionnaire used clinically to screen for GAD and assess symptom severity (sensitivity of 89%, specificity of 82%) (33).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [33] source

      The Scientific considerations section discusses patient self-reports for rheumatoid arthritis, and the Definitions section discusses validation generally. Neither addresses the GAD-7. Searches for GAD-7, anxiety screening, and the stated sensitivity and specificity found no passage in our copy supporting the claim. (LLM, conf=0.76)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    The intervention content is based on a framework from previously developed in-person and app-based mindfulness training protocols that share reinforcement learning as a core mechanism and have produced clinically meaningful outcomes.

    “The intervention content is based on a framework from previously developed in-person and app-based MT protocols that share a core underlying mechanism (reinforcement learning) that have yielded clinically meaningful outcomes (e.g., cessation of smoking and overeating) (24–27).”
    Quote in the paperNot a substantial claim2 of 4 sources checked
    • cites [24] source
    • cites [25] source

      The Introduction (page unavailable) says the smartphone smoking-cessation app was based on an efficacious in-person mindfulness program, and reports higher abstinence rates in a prior in-person trial. The copy does not identify reinforcement learning as a shared mechanism or address overeating outcomes. Its Primary Outcome section (page unavailable) reports no improvement in smoking abstinence for the app versus control. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [26] source
    • cites [27]

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

  • May combine two claims.

    Study design and conductreasoning

    A sample of 64 would have 80% power for non-reactivity and 83% power for worry-related sleep disturbance to detect a statistically significant difference, and 80 individuals were recruited to allow for 20% attrition.

    “Using the effect size of 0.52, we determined that n=64 would have 80% and 83% power (two-sided type I error) to detect a statistically significant difference in changes non-reactivity scores and WRSD respectively. To account for 20% attrition, we recruited 80 individuals with worry interfering with sleep.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [9] source

      The cited paper’s Discussion (page unavailable) reports a Cohen’s d of 1.06 for change in anxiety, but does not report the claimed 0.52 effect size. Its Results (page unavailable) describe 89 enrolled participants, not a power calculation for non-reactivity or worry-related sleep disturbance. Searches for 0.52, those outcomes, sample-size power, and attrition found no passage addressing the claim. (LLM, conf=0.76)

      Experimental — accuracy not yet measured

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

    Study design and conductcitation

    The study was approved by the Brown University Institutional Review Board and pre-registered at ClinicalTrials.gov, with a published protocol paper.

    “The study was approved by the Brown University Institutional Review Board and study design, statistical analyses, and outcomes were pre-registered at ClinicalTrials.gov in addition to the publication of a protocol paper (22).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [22] source

      The cited work is a published study protocol, but its Methods > Monitoring section says Brown University IRB approval 'will be obtained' before enrollment, not that it had already been granted. Measurements > Open Science approach likewise says the study 'will preregister' on ClinicalTrials.gov; it does not establish that the design, analyses, and outcomes had already been preregistered. (LLM, conf=0.91)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S2 (checkable).

    Premisecitation

    Mindfulness is a form of mental training that increases interoceptive awareness to reduce reactivity to stress.

    “mindfulness is a form of mental training that increases interoceptive awareness to reduce reactivity to stress (10,11).”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [10]

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

    • cites [11] source

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Premisecitation

    A relatively low-cost mobile application can be widely disseminated and may increase treatment access and utilization, especially among underserved populations.

    “Accessibility is an important area of future study: a relatively low-cost mobile application can be widely disseminated and may increase treatment access and utilization especially among underserved populations (44–46).”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [44]

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

    • cites [45] source

      Recommendation 7 (page unavailable) says new technologies may increase the reach and access of mindfulness-based interventions and that technology-driven formats may aid dissemination. It does not specifically address a low-cost mobile application, increased treatment utilization, or benefits especially for underserved populations. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [46] source

  • May combine two claims.

    Findingown data

    In a modified intent-to-treat analysis, worry-related sleep disturbance scores fell by 27% in the TAU+MT group and 6% in the TAU group at 2 months, with median change 11 versus 15 and P = .001.

    “In a modified intent-to-treat analysis, WRSD scores decreased by 27% in TAU+MT (n=36) and 6% in TAU (n=35) at 2 months (median [IQR] change: 11 [4.3] v. 15 [5.0], P = .001).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    TAU + MT (n=24) reported an average increase in SPT from 452 to 458 minutes, while TAU (n=30) reported no change (464 minutes).

    “TAU + MT (n=24) reported an average increase in SPT from 452 to 458 minutes compared to TAU (n=30) who reported no change (464 minutes).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the complete-case analysis (46 participants), findings for TST corroborated the imputed-data analysis (P = .86), but a significant between-group difference was found in SE with 97% in TAU + MT and 96% in TAU (P = .04).

    “46 participants were included in the CC analysis which corroborated the findings from the analysis with imputed data for TST (P = .86) however a significant between-group difference was found in SE with 97% in the TAU + MT group and 96% in TAU (P = .04; see Appendix 3, Supplemental Digital Content 3).”
    Quote in the paperNot a substantial claim

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

    Findingown data

    Average and median estimated sleep durations were greater than 7 hours at all time points in both groups.

    “Average and median estimated sleep durations were > 7 hours at all time points in both groups.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    After imputing missing data, no significant between-group differences were found in average estimated TST or SE at 2 months post treatment initiation (P = .52; P = .70).

    “After imputing missing data, no significant between-group differences were found in average estimated TST or SE at 2 months post treatment initiation (P = .52; P = .70).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    SE remained the same in TAU + MT (96%) while it increased from 95% to 96% in TAU.

    “SE remained the same in TAU + MT (96%) while it increased from 95% to 96% in TAU.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Time was not significantly associated with a change in non-reactivity scores for the TAU + MT group at 1 month but was at 2 months.

    “Interestingly, time was not significantly associated with a change in non-reactivity scores for the TAU + MT group at 1 month but it was at 2 months.”
    Quote in the paperSubstantial claim

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

    Study design and conductnone given

    The randomization schema was generated by an independent statistician in variable blocks of four and six.

    “The randomization schema was generated by an independent statistician in variable blocks of four and six.”
    Quote in the paperNot a substantial claim

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

    Study design and conductcitation

    A consumer Fitbit device was chosen instead of a research-grade actigraph because it represents what individuals can access, though this trades accuracy and precision for convenience and lower participant burden.

    “This consumer device was selected rather than a research-grade actigraph because it is most representative of what individuals can access for personal use. While there is a trade-off in terms of accuracy and precision in sleep measurement, consumer devices provide the benefit of convenience and reduce participant burden (34).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [34] source

  • May combine two claims.

    Premisecitation

    A small number of mindfulness-based interventions have shown varying efficacy for treating sleep disturbance, and few used randomized controlled trial designs.

    “A small number of MBIs have shown varying degrees of efficacy for treating sleep disturbance, though few used randomized controlled trial designs (15).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] source

  • May combine two claims.

    Premisecitation

    Sleep-specific worry predicts both sleep disturbance and sleep-related impairment even after controlling for demographics, chronotype, and overall health status.

    “Sleep-specific worry predicts both sleep disturbance and sleep-related impairment even after controlling for demographics, chronotype, and overall health status (4).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [4] source

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

    Study design and conductown data

    Seventy-one participants were included in the intention-to-treat analysis.

    “71 participants were included in the ITT analysis (see CONSORT diagram, Figure 1).”
    Quote in the paperNot a substantial claim

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

    Study design and conductown data

    Analyses used an intent-to-treat approach.

    “Analyses were conducted in R (v.4.0.2) using an intent-to-treat approach (ITT).”
    Quote in the paperNot a substantial claim

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

    Study design and conductnone given

    The person randomizing participants and conducting assessments was not involved in data analysis, and the principal investigator, statistician, and data analysts were blinded until all analyses were complete.

    “The individual responsible for randomization of participants and conducting the assessments was not involved in data analysis. The Principal Investigator, statistician, and individuals conducting data analysis were blinded until all analyses were complete.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    Cognitive behavioral treatment of insomnia is an effective therapy that targets cognitions and maladaptive behaviors associated with coping with poor sleep.

    “cognitive behavioral treatment of insomnia (CBT-I) is an effective therapy that targets cognitions and maladaptive behaviors associated with coping with poor sleep (16)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [16] source

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

    Study design and conductcitation

    The Penn State Worry Questionnaire is a validated 16-item questionnaire for assessing worry.

    “The PSWQ is a 16-item questionnaire validated to assess worry (29).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [29] source

  • May combine two claims.

    Interpretationreasoning

    App-based mindfulness training can be disseminated widely and may mechanistically target worry, disrupting cognitive processes that lead to emotional distress and heightened physiological arousal that may drive insomnia.

    “A potential advantage of app-based MT for sleep disturbances related to anxiety and worry is that it can be disseminated widely and may mechanistically target worry, disrupting cognitive processes that lead to emotional distress and heightened physiological arousal that may ultimately drive insomnia.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    The study was a parallel group randomized controlled trial.

    “This was a parallel group randomized controlled trial.”
    Quote in the paperSubstantial claim

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

    Study design and conductown data

    Gender was included as a covariate in all generalized estimating equation models because of a significant baseline between-group difference.

    “Due to a significant between-group difference at baseline, gender was included as a covariate in all GEE models.”
    Quote in the paperNot a substantial claim

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

    Study design and conductcitation

    The non-reactivity subscale of the Five Facet Mindfulness Questionnaire is validated for independent use to assess emotional reactivity.

    “The non-reactivity subscale is validated for use independently and is composed of 7 questions from the 39-item FFMQ (30).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [30] source

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

    Study design and conductreasoning

    Average estimated total sleep time was calculated only for participants with at least 3 days recorded during the wear period to improve reliability.

    “To improve reliability, average estimated TST was calculated for participants with ≥ 3 days recorded during the wear period.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Allocation was concealed using opaque, sealed envelopes prepared, reviewed, and sealed by two individuals independent of the research team.

    “participants received an opaque, sealed envelope which contained their group assignment to treatment-as-usual (TAU) or TAU + MT (1:1 ratio). The envelopes were prepared, reviewed, and sealed by two individuals independent of the research team.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    Missing Fitbit and paper sleep diary data were found to be missing completely at random, and multiple imputation created five datasets to correct for bias from missing data.

    “The missing data for both Fitbit and PSDs were found to be missing completely at random and multiple imputation was used to create five imputed datasets to correct for any bias introduced by missing data.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The study results demonstrate a mechanistic link between mindfulness training and increased emotional non-reactivity, decreased worry, and reduced reported sleep disturbances.

    “Results from this study demonstrate a mechanistic link between MT and increased emotional non-reactivity, decreased worry, and reduction in reported sleep disturbances”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Stress-related worry may exacerbate sleep reactivity, which can cause consistent sleep responses to stress over time regardless of stimuli and increase the risk of developing insomnia.

    “Stress-related worry may exacerbate sleep reactivity, which can cause consistent sleep responses to stress over time regardless of stimuli, thus increasing the risk of developing insomnia (8).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] source

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

    Study design and conductcitation

    Risk of bias was assessed with the Cochrane Collaboration's tool across seven domains.

    “Using the Cochrane Collaboration’s tool for evaluating risk of bias, we assessed potential bias across seven domains: random sequence generation, allocation concealment, blinding of participants and researchers, blinding of outcome assessment, incomplete outcome data, selective reporting, and other bias (41).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [41] source

  • May combine two claims.

    Interpretationown data

    The mediation models align with mindfulness theory and are suggestive of a treatment mechanism that can more precisely facilitate the process of improving sleep disturbance.

    “The mediation models align with mindfulness theory and are suggestive of a treatment mechanism that can more precisely facilitate the process of improving sleep disturbance.”
    Quote in the paperSubstantial claim

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

    Premisecitation

    Concerns about disturbed sleep stemming from people monitoring their sleep on wearable devices and believing device data over more validated and accurate measures has led to the description of orthosomnia, a sleep disorder based on worry about sleep.

    “Indeed, concerns about disturbed sleep stemming from people monitoring their sleep on wearable devices and believing device data over more validated and accurate measures (e.g. believing a wearable over an overnight sleep study conducted by a certified lab and interpreted by a licensed sleep medicine physician) has led to the description of orthosomnia, a sleep disorder based on worry about sleep”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [49]

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

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.

    Premisenone given

    MBI studies benefit from comparison to TAU or an intervention with similar cognitive effort, though it is often difficult to find appropriate active controls.

    “Finally, MBI studies benefit from comparison to TAU or an intervention with similar cognitive effort, though it is often difficult to find appropriate active controls.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    A recent study found 125 million new wearable devices were shipped worldwide over a 3-month period in 2020.

    “A recent study found 125 million new wearable devices were shipped worldwide over a 3-month period in 2020 (48).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [48]

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

  • May combine two claims.

    Interpretationown data

    Participants did not report reductions in time in bed (sleep period time) as would be expected in patients employing CBT-I, supporting the notion that the MT intervention works to improve sleep through a different mechanism than CBT-I.

    “Moreover, our participants did not report reductions in time in bed (sleep period time) as would be expected in patients employing CBT-I, supporting the notion that our MT intervention works to improve sleep through a different mechanism than CBT-I.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    MT reduced worry, and increases in non-reactivity accounted for 49% of this effect.

    “Taken together, these findings indicate that MT reduced worry and increases in non-reactivity accounted for 49% of this effect, suggesting that one mechanism by which participants’ worry decreased was their ability to not get caught up in thoughts and emotions.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    App-based MT effectively increased non-reactivity with concomitant decreases in self-reported worry and worry-disrupted sleep.

    “This study provides evidence for this mechanism, as app-based MT effectively increased non-reactivity with concomitant decreases in self-reported worry and worry disrupted sleep.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    MT effectively reduced worry and decreased self-reported worries about sleep but showed no significant effect on quantitative measures of sleep duration.

    “We found that MT effectively reduced worry and decreased self-reported worries about sleep but showed no significant effect on quantitative measures of sleep duration.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    Increases in non-reactivity mediated reductions in worry, and reductions in worry mediated reductions in WRSD.

    “From a mechanistic perspective, we found that increases in non-reactivity mediated reductions in worry and reductions in worry mediated reductions in WRSD.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The study demonstrates clinical efficacy and full mediation of the effects of MT on perceived sleep disturbances by worry.

    “Our study demonstrates clinical efficacy and full mediation of the effects of MT on perceived sleep disturbances by worry.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    MT reduced WRSD, and reductions in worry accounted for 53% of this effect.

    “Taken together, these findings indicate that MT reduced WRSD and reductions in worry accounted for 53% of this effect, suggesting that one mechanism by which participants’ WRSD decreased was their ability to decrease hyperarousal through learned non-reactivity.”
    Quote in the paperSubstantial claim

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

    Premisecitation

    A cited limitation of the current body of research on MBIs is the narrow focus on novel and/or clinical populations.

    “It is important to note that a cited limitation of the current body of research on MBIs is the narrow focus on novel and/or clinical populations (47).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [47] source

  • May combine two claims.

    Interpretationreasoning

    The results of the current study provide additional support for the existence of a dose-response and/or sleeper effect.

    “The results of the current study provide additional support for the existence of a dose-response and/or sleeper effect.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    The field of mindfulness research has received criticism for lack of reproducibility; few MBIs surpass Stage 0 or I of the NIH stage model, and less than 2% reach the stage of effectiveness or implementation/dissemination research.

    “The field of mindfulness research has received criticism for lack of reproducibility. Few MBIs surpass Stage 0 or I of the stage model established by the National Institutes of Health (NIH) for clinical science and less than 2% reach the stage of effectiveness or implementation/dissemination research (47).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [47] source

  • May combine two claims.

    Premisecitation

    Fitbit devices exhibit better sensitivity than specificity, as they overestimate TST and underestimate restlessness.

    “However, it has been shown that Fitbit devices exhibit better sensitivity than specificity, as they overestimate TST and underestimate restlessness (50,51).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [50]

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

    • cites [51]

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

  • May combine two claims.

    Interpretationown data

    The lack of effect on quantitative sleep duration may be due to a combination of Fitbit device limitations and a ceiling effect: sleep efficiency calculated from Fitbit data was 96% at baseline for both groups, mirroring the relatively high sleep durations reported on baseline sleep diaries.

    “This may be due to a combination of Fitbit device limitations and the existence of a ceiling effect: sleep efficiency calculated from Fitbit data was 96% at baseline for both groups, mirroring the relatively high sleep durations that participants in both groups reported on their baseline sleep diaries.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    MT reduced worry and anxiety and decreased self-reported worries about sleep, with the effect first observed between groups and then replicated within the study when the control group received the active intervention.

    “We found that MT reduced worry and anxiety and decreased self-reported worries about sleep – an effect that was first observed between groups and then replicated within the study when the control group received the active intervention.”
    Quote in the paperSubstantial claim

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

    Interpretationnone given

    Consumer devices are most reflective of what the study demographic would use on a personal basis to track sleep duration and quality.

    “Consumer devices are also most reflective of what our study demographic would use on a personal basis to track sleep duration and quality.”
    Quote in the paperNot a substantial claim
50 of 50

  • The paper relies on this without support.

    Fitbit-derived estimates of total sleep time and sleep efficiency are accurate enough to detect between-group differences in sleep outcomes.

    “Fitbit devices were used to estimate total sleep time (TST) as well as total time awake and bed/wake times using the device’s sleep algorithms.”
    “While there is a trade-off in terms of accuracy and precision in sleep measurement, consumer devices provide the benefit of convenience and reduce participant burden (34).”

  • The paper relies on this without support.

    This is the first randomized controlled trial to evaluate the efficacy of app-based mindfulness training for improving anxiety-related sleep disturbance.

    “To our knowledge, this is the first RCT to evaluate the efficacy of app-based MT in improving anxiety-related sleep disturbance.”

  • The paper relies on this without support.

    Sleep-related worry imposes a large burden on the U.S. population and represents an unmet public health need.

    “The immense burden of sleep-related worry on the overall U.S. population constitutes an unmet public health need.”

  • The paper relies on this without support.

    Sleep disturbances and worry about sleep affect many people at a severity that does not always warrant a clinical diagnosis.

    “To conclude, sleep disturbances and worry about sleep affect a broad range of individuals at a severity that may not always warrant clinical diagnosis.”

  • The paper relies on this without support.

    Making digital therapeutics such as app-based mindfulness training available to the general population improves preventive treatment-seeking behavior.

    “Making digital therapeutics like app-based MT available to the general population serves to improve preventive treatment-seeking behavior.”
5 of 5

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • TAU baseline sleep efficiency is reported as both 95% and 96%

    Minor

    The Fitbit results give TAU a baseline sleep efficiency of 95%, while the discussion says it was 96% in both groups.

  • Four-month completion percentage uses the wrong denominator

    Minor

    The stated 22 of 36 participants equals 61%, not 73%.

    Reported 73 · recomputed 61.111111

2 of 2

Cites

Flagged first, then by citations

2 of the 50 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

Related

Authors
Gao, M., Roy, A., Deluty, A., Sharkey, K. M., Hoge, E. A., Liu, T., & Brewer, J. A.
Affiliations
Brown University (US)
Corresponding author
Brewer, Judson A.
ORCID
Sharkey, Katherine M.
Venue
Psychosomatic Medicine
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2022-04-14
Volume
84
Issue
5
Pages
632-642
ISSN
  • 0033-3174 (ISSN-L)
  • 1534-7796
DOI
10.1097/psy.0000000000001083
PMC
PMC9167766
OpenAlex
W4223903862
Cited by
24
References
50
Citations by year
2026: 6 · 2025: 7 · 2024: 5 · 2023: 6
FWCI
4.13
Type
journal article
Language
en
Open access
Locations
  • Psychosomatic Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute on Aging (R21AG062004)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
Keywords
mindfulness training, sleep disorders, anxiety, worry, mobile health apps, digital mental health interventions, sleep efficiency, total sleep time, mediation analysis, Fitbit
MeSH terms
Anxiety, Anxiety Disorders, Humans, Sleep, Sleep Wake Disorders, Mobile Applications, Mindfulness

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read under definition version 3 (extract-v3) on 2026-09-28.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-09-28.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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