Can Mindfulness Mechanistically Target Worry to Improve Sleep Disturbances? Theory and Study Protocol for App-Based Anxiety Program.

May combine two claims.

In smoking and emotional eating studies, mindfulness training decoupled craving from behavior, with a fivefold increase in smoking cessation and a 40% reduction in craving-related eating.

“in studies of cigarette smoking and emotional eating, mindfulness training was found to mechanistically decouple cigarette or food craving from smoking or eating, with a subsequent fivefold increase in smoking cessation rates, and a 40% reduction in craving-related eating, respectively (Brewer et al., 2011; Elwafi, Witkiewitz, Mallik, Thornhill-IV, & Brewer, 2013; Ashley E. Mason, Jhaveri, Cohn, &”

• cites Brewer et al., 2011 sourcePartly supported

  The Results (§3.2; page not provided) report 31% point-prevalence abstinence with mindfulness training versus 6% with the comparison treatment at 17 weeks—approximately fivefold. The Introduction (§1) proposes that mindfulness may help people experience cravings without smoking, but this trial does not establish mechanistic decoupling. It does not study emotional eating or report a 40% reduction in craving-related eating. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites Elwafi, Witkiewitz, Mallik, Thornhill-IV, & Brewer, 2013 sourcePartly supported

  The Results (§3.2; page unavailable) report that the craving–smoking correlation weakened after mindfulness training. The Introduction (§1; page unavailable) reports 31% versus 6% abstinence at four months in an earlier trial, consistent with an approximately fivefold difference. This paper does not report the claimed 40% reduction in craving-related eating, and its smoking findings do not establish that decoupling caused the higher cessation rate. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites Ashley E. Mason, Jhaveri, Cohn, & Brewer, 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).

Robust mediation analysis will use the R package ROBMED, which follows Preacher and Hayes principles but uses an MM-regression estimator and robust bootstrap to handle model violations like outliers.

“For the latter, we will utilize the ROBMED package in R which follows the same principles found in the Preacher & Hayes test (Preacher & Hayes, 2008) but employs a robust MM-regression estimator (Yohai, 1987) and a fast and robust bootstrap (Salibian-Barrera & Van Aelst, 2008) to compensate for deviations from model assumptions, for example, outliers (Alfons, Ates, & Groenen, 2018).”

• cites Preacher & Hayes, 2008 sourceSupported
• cites Yohai, 1987Not matched

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

• cites Salibian-Barrera & Van Aelst, 2008Not matched

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

May combine two claims.

Mindfulness training has shown promise in both efficacy and cost, with effect sizes comparable to gold-standard treatments.

“Next-generation behavioral treatments such as mindfulness training have shown promise both in efficacy and cost (treatment is largely delivered in group format), with effect sizes rivaling gold-standard treatments (Goyal et al., 2014; Hofmann, Sawyer, Witt, & Oh, 2010).”

• cites Goyal et al., 2014 sourcePartly supported

  The Discussion reports small improvements in anxiety and depressive symptoms and says their effect sizes are comparable to those expected from antidepressants in a primary-care population. It does not support the claim about cost or establish that mindfulness rivals gold-standard treatments generally; the Discussion cautions that trials comparing meditation with known treatments were too small to establish equivalence. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites Hofmann, Sawyer, Witt, & Oh, 2010 sourcePartly supported

  The Results (page unavailable) report promising effects on anxiety and mood symptoms; in patients with anxiety and mood disorders, effect sizes of 0.97 and 0.95 are similar to the conventional CBT estimate of 0.95 cited in the Discussion. But the Discussion calls for future comparisons of cost-effectiveness, so this paper does not establish a cost advantage or support the group-format explanation for one. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

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

ClinicalTrials.gov was selected instead of OSF because a 2016 NIH policy requires its use.

“This was chosen in place of Open Science Framework (OSF) because the National Institute of Health requires its use per a 2016 policy update (Toelch & Ostwald, 2018).”

• cites Toelch & Ostwald, 2018 sourceCould not verify

  The Preregistration section (page unavailable) describes OSF as a suitable platform, and An example project (page unavailable) says the authors uploaded data to OSF. Searches for ClinicalTrials.gov and a 2016 NIH registration policy found no passage addressing either the alleged requirement or the reason for choosing ClinicalTrials.gov instead of OSF. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

May combine two claims.

Questions persist about the scalability and clinician competence of in-person mindfulness-based interventions.

“However, concerns remain around scalability and competency of in-person delivered MBI treatments (Crane et al., 2012).”

• cites Crane et al., 2012 sourceSupported

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

Once the program reached a Net Promoter Score of 96, its videos, animations, and brief exercises were finalized and packaged for Android and iOS delivery.

“After a Net Promoter Score (“How likely is it that you would recommend this to a friend or colleague?”) of 96 was achieved (70+ is rated as “world class”), videos, animations, and in-the-moment exercises were finalized and bundled into an app-based delivery platform that can be delivered via Android and iOS operating systems.”

Classified as probably not a substantial claim.

The mechanisms by which mindfulness may affect worry and subsequent sleep disturbances have not been clarified.

“Moreover, the mechanisms by which mindfulness may affect worry and subsequent sleep disturbances have not been elucidated.”

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

The Unwinding Anxiety app is similar to the combined MBSR/CBT-i curriculum studied by Ong et al., with significant overlap in principles, components, and activities.

“The Unwinding Anxiety app bears similarity to the combined MBSR/CBT-i curriculum studied by Ong et al – and the principles, components, and activities overlap significantly.”

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

Participants will not know which group they are in.

“Participants will be blinded to group assignment.”

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

Participants will be allocated to the two arms in equal numbers under a parallel-group design.

“Randomization will be on a 1:1 schedule in a parallel group design.”

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

The authors will consider LASSO to select important covariates and reduce possible model overfitting.

“To overcome possible model overfitting, we will consider using the least absolute shrinkage and selection operator (LASSO) for the selection of important covariates in the model (Tibshirani, 1996).”

• cites Tibshirani, 1996Not matched

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

May combine two claims.

Reinforcement learning depends on the rewards of one's actions, but a person who habitually reacts to a trigger may not be aware of the present-moment reward value of that action.

“Reinforcement learning is dependent upon the rewards of one’s actions; however, if someone is habitually reacting to a trigger, he or she may not be aware of the present-moment reward value of the action.”

Classified as probably not a substantial claim.

Tallis and Eysenck proposed that worry engages fight-or-flight states by alerting and preparing people for unresolved threatening situations.

“Tallis and Eysenck (1994) proposed that worry engages fight-or-flight states through alerting and (theoretically) preparing individuals for unresolved threatening situations.”

• cites Tallis and Eysenck (1994)Not 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).

The person who randomizes participants and performs assessments will be excluded from analyzing the data.

“The individual who is responsible for the randomization of participants and conducting the assessments will not be involved in data analysis.”

May combine two claims.

In the authors' earlier study, non-reactivity rose by 3.5 points (SD 4.85) and PSQI sleep disturbance fell by 2.6 points (SD 3.6).

“This prior study found an increase of 3.5 points (SD = 4.85) in non-reactivity and a decrease of 2.6 points (SD = 3.6) in sleep disturbances based on the Pittsburgh Sleep Quality Index.”

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

At the final assessment, adverse events and medication changes will be asked about; severe spontaneous events will be reported immediately, while others will be recorded and reported quarterly.

“Adverse events and medication changes will be solicited at each participant’s final assessment for the study. Severe spontaneously reported adverse events will be reported immediately and all others will be recorded and reported quarterly.”

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

An independent statistician will generate the allocation sequence using random block sizes of four and six, aiming for roughly equal arm sizes.

“Assignments will be generated by an independent statistician in random blocks of four and six to ensure approximately equal numbers of participants in the two study arms.”

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

Two people not involved in data collection will prepare and check the envelopes, which will stay sealed until after enrollment and consent.

“The envelopes will be prepared, reviewed by two individuals independent of data acquisition, and will remain sealed before participants are enrolled and consented.”

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

The Science of Behavior Change approach tests whether an intervention engages its intended target and whether that target engagement leads to a desired behavior change outcome.

“The SOBC approach involves testing whether an intervention engages an intended target, and whether target engagement leads to a desired behavior change outcome (Eisenberg et al., 2017).”

• cites Eisenberg et al., 2017Not matched

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

May combine two claims.

A one-sample t-test indicated that 64 participants would provide 80% power for non-reactivity change and 83% power for sleep quality change, using a two-sided type I error.

“A one sample t-test determined a sample size of 64 will have 80% and 83% power with two-sided type I error, to detect a statistically significant difference between groups in changes non-reactivity scores and sleep quality respectively.”

• AssumptionRests on an assumption: No prior studies of the intervention existed at the time.

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

Worry is the central defining feature of generalized anxiety disorder, though it also occurs in other anxiety disorders.

“Worry is widely regarded as the central defining feature of generalized anxiety disorder, although it also occurs in other anxiety disorders (Association, 2013).”

• cites Association, 2013Not 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.

Anxiety- and worry-specific content was created from clinical experience with anxious patients and repeated pilot testing among self-identified anxious members of the public, then refined.

“Specific anxiety and worry-related content was developed from a combination of clinical experience with anxious individuals and several rounds of iterative pilot testing with the general public who self-described as anxious, after which the content and delivery of the modules and exercises were refined.”

Classified as probably not a substantial claim.

Allocation will be concealed in sequentially numbered opaque sealed envelopes given to eligible participants.

“Eligible participants will receive a sequentially numbered, opaque, sealed envelope containing their random assignment: treatment as usual (TAU) or TAU + an app-based mindfulness training (TAU + MT).”

Classified as probably not a substantial claim.

The authors used their earlier MBSR study in anxious individuals to guide the sample-size calculation.

“To date there have not been previous studies of the intervention, therefore sample size calculations were informed by our previous work with MBSR for individuals with anxiety.”

• AssumptionRests on an assumption: No prior studies of the intervention existed at the time.

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

The planned recruitment is 80 people to allow for 20% dropout.

“To account for 20% attrition, we plan to recruit 80 individuals.”

May combine two claims.

In a 24-hour monitoring study, people with high worry in bed had lower sleep efficiency, more nocturnal awakenings, and higher heart rate than those without high worry.

“A 24-hour monitoring study indicated that participants with high levels of worry in bed had lower sleep efficiency (expressed as a percentage of time in bed), increased nocturnal awakenings, and a higher heart rate than those who did not experience high levels of worry (Weise, Ong, Tesler, Kim, & Roth, 2013).”

• cites Weise, Ong, Tesler, Kim, & Roth, 2013 sourceNot checked — no full text of the source

May combine two claims.

A prolonged fight-or-flight state may have far-reaching health consequences, including myocardial infarction and insomnia.

“A prolonged fight-or-flight state may have far-reaching health consequences, ranging from myocardial infarction to insomnia (Brosschot, Gerin, & Thayer, 2006).”

• cites Brosschot, Gerin, & Thayer, 2006 sourceNot checked — no full text of the source

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

The one- and two-month post-baseline mediation time points were selected to permit time-ordered mediation testing and to occur before TAU participants receive the intervention.

“These time points were chosen because they will allow for an evaluation of time ordered mediation and are prior to the TAU group receiving the intervention.”

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

Study data will be anonymized and kept on password-protected servers, and paper documents will be stored in a locked cabinet.

“All study data will be anonymized and stored on password protected servers while physical documents will be kept in locked filing cabinet.”

May combine two claims.

As mindfulness practice deepens, the rewards of curious awareness, even of unpleasant emotional states, become clearer because curiosity feels better than anxiety or worry thinking.

“as one deepens a mindfulness practice, the rewards of curious awareness, even of unpleasant emotional states, become clearer, because curiosity feels better than anxiety or worry thinking.”

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

The PI, statistician, and the research associate who analyzes the data will be kept unaware of group allocation.

“The Principal Investigator, statistician, and Research Associate conducting data analysis will be blinded.”

Classified as probably not a substantial claim.

Participants will be randomly allocated 1:1 to treatment as usual or treatment as usual plus app-based mindfulness training.

“Subjects will be randomly allocated (1:1) to two groups: treatment as usual (TAU) or TAU + app-based mindfulness training (MT; Unwinding Anxiety app).”

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

Cognitive behavioral therapy for insomnia has become a first-line treatment for insomnia because of its relative efficacy and clinically meaningful effect sizes.

“cognitive behavioral therapy for insomnia [CBT-i]), have become first-line therapies for the treatment of insomnia due to their relative efficacy and clinically meaningful effect sizes (Trauer, Qian, Doyle, Rajaratnam, & Cunnington, 2015).”

• cites Trauer, Qian, Doyle, Rajaratnam, & Cunnington, 2015 sourceNot checked — no full text of the source

May combine two claims.

Worry as an avoidance strategy is unpleasant and often does not consistently solve the problems that triggered it.

“worry as an avoidance strategy comes with two critical caveats: (1) worry is unpleasant, and (2) often worry thinking doesn’t consistently solve the problems that triggered it.”

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

An independent Data Safety Monitor will oversee the trial and receive regular status reports.

“This study will be overseen by an independent Data Safety Monitor (DSM) who will receive regular reports regarding the status of the study.”

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

Groups will be called Group 1 and Group 2 so that the PI and analysts remain pseudo-blinded to arm identity until analyses finish.

“Each group will be labeled “Group 1” or “Group 2” to ensure that the principal investigator and members of the study team who conduct the statistical analyses are pseudo-blinded to group membership until all analyses are complete.”

May combine two claims.

People use worry to avoid unpleasant emotions, which reduces distress and increases a sense of control, making worry an avoidance response.

“individuals engage in worry as a way to avoid unpleasant emotions, resulting in decreased distress and an increased sense of control—essentially an avoidance response (T. Borkovec, Ray, & Stober, 1998; T. D. Borkovec et al., 1983).”

• cites T. Borkovec, Ray, & Stober, 1998Not matched

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

• cites T. D. Borkovec et al., 1983 sourceNot checked — no full text of the source

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

Brown University's IRB will approve the study before enrollment, and any protocol changes will require IRB review before they are implemented.

“Prior to the enrollment of participants, approval will be obtained from Brown University’s Institutional Review Board (IRB) and any changes to the research protocol will be reviewed by the IRB before implementation.”

Classified as probably not a substantial claim.

The app-based mindfulness program is intended to reduce worry at a fundamental mechanistic level.

“This training is designed to help individuals extinguish worry at a basic mechanistic level.”

May combine two claims.

Paying attention while caught in a worry thought loop makes the behavior's result clearer and leads to a natural neural depreciation of its reward value.

“when one pays attention when getting caught in a worry thought loop, the result of the behavior becomes clearer, leading to a natural neural depreciation of its reward value.”

May combine two claims.

When the negative affective qualities of worry are strong, the prefrontal cortex disengages and higher-order functions such as problem solving are impaired.

“When the negative affective qualities of worry are strong enough, the prefrontal cortex disengages, impeding higher-order prefrontal cortical function, such as problem solving (Arnsten, 2009, 2015).”

• cites Arnsten, 2009, 2015Not matched

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

May combine two claims.

Mindful nonjudging and curious allowing of experience helps people avoid being triggered by positive or negative affective states and thus avoid habitual behavior.

“when someone is being mindful, the attitudinal quality of not judging and allowing the experience to unfold with curiosity helps avoid being triggered by either positive or negative affective states, thus avoiding habitual behavior (Brewer & Pbert, 2015).”

• cites Brewer & Pbert, 2015Not matched

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

May combine two claims.

Delivering cognitive anxiety treatments at population scale is difficult because trained clinicians are scarce, therapy takes time, and costs are high.

“Cognitive approaches to treat anxiety can be difficult to deliver at a population level due to the limited availability of highly trained individuals, time requirements of therapy, and associated costs; therefore, mindfulness-based approaches, which are delivered in a group format, may address some of these challenges.”

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

The trial will be registered in advance on ClinicalTrials.gov.

“We will preregister the study on ClinicalTrials.gov.”