Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential

May combine two claims.

Across all modules, therapists delivered 86% of essential components and demonstrated capable skills (M = 3.2 out of 4), indicating sufficient adherence and predominantly capable competence.

“Across all modules, on average, therapists delivered 86% (12%) of essential components and demonstrated capable skills (M = 3.2 [0.4] out of 4), indicating sufficient adherence and predominantly capable competence (Cross et al., 2014).”

• cites Cross et al., 2014 sourceDisputed

  The Abstract’s Results report that trainers delivered two-thirds of the program on average, not 86% of essential components. The Discussion says only 18% of trainer observations were rated solidly competent, contrary to the claim of predominantly capable competence. The paper studies trainers, not therapists; our copy does not report the claimed mean of 3.2 out of 4. (LLM, conf=0.90)

  Checked by a reasoning model — may be wrong.

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Behavioral health providers need brief behavioral anxiety interventions that are feasible within PCBH and can accommodate the full range of anxiety presentations in severity, disorder, and comorbidities.

“To ease implementation to maximize uptake in routine care (Cully et al. 2023), BHPs need brief behavioral anxiety interventions that are feasible within PCBH and can accommodate the full range of anxiety presentations in terms of symptom severity, disorder, and comorbidities (Seekles et al., 2013; Shepardson et al., 2018).”

• cites Seekles et al., 2013 sourceNot checked — no full text of the source
• cites Shepardson et al., 2018 sourcePartly supported

  The Conclusion calls for brief, PCBH-compatible interventions accommodating varied anxiety presentations, from subthreshold through mild and moderate severity, with or without comorbid depression. The citing sentence overextends this to the full range of severity and comorbidities: the Introduction says BHPs may refer patients with severe or long-standing symptoms to specialty care, and the Conclusion specifies depression rather than comorbidities generally. Page numbers are unavailable in our copy. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

PCBH interventions must be brief and time-limited, for example deliverable in six or fewer 30-minute sessions.

“Empirically supported anxiety interventions from specialty care (Norton & Price, 2007) are not readily translated to PCBH, where interventions must be brief and time-limited (e.g., deliverable in 6 or fewer 30-minute sessions; Beehler et al., 2013; Rowan & Runyan, 2005).”

• cites Beehler et al., 2013 sourcePartly supported

  The Discussion describes care in this model as brief and time-limited, and the Results list appointments typically lasting 30 minutes or less and patients typically receiving six or fewer appointments per episode of care. Those passages support the example as a typical practice, but not the claim that every PCBH intervention must fit within those limits. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites Rowan & Runyan, 2005 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Anxiety and depressive symptom severity were assessed using the GAD-7 and PHQ-9.

“Anxiety and depressive symptom severity (last 2 weeks) were assessed using the GAD-7 (Spitzer et al., 2006) and PHQ-9 (Kroenke et al., 2001), respectively.”

• cites Spitzer et al., 2006 sourceNot checked — no full text of the source
• cites Kroenke et al., 2001 sourceSupported

May combine two claims.

The OASIS is a valid, reliable measure that captures frequency and intensity of anxiety symptoms as well as avoidance and functional impairment.

“Because the GAD-7 was used in MBC in the intervention and control conditions, we also collected the five-item Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al., 2006). This valid, reliable (α = .80-.91) measure captures frequency and intensity of anxiety symptoms as well as level of avoidance and functional impairment (Campbell-Sills et al., 2009).”

• cites Norman et al., 2006 sourceNot checked — no full text of the source
• cites Campbell-Sills et al., 2009 sourcePartly supported

  The Introduction and Method describe five OASIS items covering anxiety frequency and intensity, avoidance, and functional impairment; the Discussion concludes that the measure is reliable and valid in clinical samples. The citing sentence also attributes an α range of .80–.91 to this source, but the Results report α = .84, not that range. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

May combine two claims.

Interrater reliability was acceptable for adherence (kappa = .61) and competence (ICC = .79).

“Interrater reliability was acceptable for adherence (kappa = .61, considered substantial agreement; Landis & Koch, 1977) and competence (intraclass correlation = .79, considered good agreement; Koo & Li, 2016).”

• cites Landis & Koch, 1977 sourceNot checked — no full text of the source
• cites Koo & Li, 2016 sourceSupported

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

Probable PTSD was assessed using the PC-PTSD-5, which has good diagnostic accuracy.

“Probable PTSD was assessed using the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5; Prins et al., 2016), which has good diagnostic accuracy.”

• cites Prins et al., 2016 sourceSupported

May combine two claims.

MAST-V and other CBT interventions are a good fit for PCBH practice because they flow naturally from functional assessment, can be delivered quickly, and provide concrete self-management skills for patients to practice at home.

“MAST-V and other CBT interventions are a good fit for PCBH practice because they flow naturally from functional assessment, can be delivered quickly, and provide concrete self-management skills for patients to practice at home (Beehler et al., 2013; Rowan & Runyan, 2005).”

• cites Beehler et al., 2013 sourcePartly supported

  The Background describes focused functional assessments and targeted interventions in a brief treatment model, and the Discussion says CCC sessions should be 30 minutes or less. The Results also identify developing a specific plan with the patient as essential. These passages support the general fit of brief, assessment-informed interventions, but do not identify MAST-V or establish that CBT interventions provide self-management skills for practice at home. Page numbers are not supplied in our copy. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites Rowan & Runyan, 2005 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Among therapists, acceptability of MAST-V was assessed using four-item validated measures of intervention acceptability and appropriateness.

“Among therapists, acceptability of MAST-V was assessed using four-item validated measures of intervention acceptability and appropriateness (α = .90, 92; Weiner et al., 2017).”

• cites Weiner et al., 2017 sourceSupported

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

Among patients, three validated measures were used at post-assessment: the CSQ, WAI, and an adapted ERS.

“Among patients, three validated measures were used at post-assessment. Treatment satisfaction was assessed using the eight-item Client Satisfaction Questionnaire (CSQ; α = .96; Larsen et al., 1979), therapeutic alliance using the 12-item Working Alliance Inventory Short-Form Revised (WAI; α = .92; Hatcher & Gillaspy, 2006), and treatment credibility using an adapted four-item version (Calleo et al”

• cites Larsen et al., 1979 sourceNot checked — no full text of the source
• cites Hatcher & Gillaspy, 2006 sourceNot checked — no full text of the source
• cites Calleo et al., 2013 sourcePartly supported

  The Method > Outcome Measures passage describes a four-item ERS used to assess treatment credibility and expectancy, supporting the citation’s identification of the measure. It specifies that only the first three items assess credibility; the fourth assesses expectancy. The passage also does not describe this version as adapted. (LLM, conf=0.83)

  Experimental — accuracy not yet measured

May combine two claims.

Patients receiving MAST-V showed clinically significant improvements in anxiety symptoms and functioning, as well as other comorbid symptoms.

“As in prior RCTs of CBT-based anxiety interventions (Cully et al., 2017; Stanley et al., 2009), patients receiving MAST-V showed clinically significant improvements in anxiety symptoms and functioning, as well as other comorbid symptoms.”

• cites Cully et al., 2017 sourceSupported
• cites Stanley et al., 2009 sourceSupported

May combine two claims.

On average, MAST-V treatment comprised 5 sessions, consistent with the goal of time-limited services in primary care.

“On average, MAST-V treatment comprised 5 sessions, consistent with the goal of time-limited services in primary care (Beehler et al., 2013).”

• cites Beehler et al., 2013 sourcePartly supported

  The Background describes a brief treatment model in primary care, and the Results (Delphi process findings, Table 2, item 34) identify six or fewer appointments per episode as an essential practice. These passages support the time-limited-services rationale, but they do not report MAST-V treatment outcomes or an average of five sessions. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

May combine two claims.

High rates of treatment engagement (88%) and retention (76%) were found for MAST-V.

“Similar to prior RCTs of brief CBT in primary care (Cully et al., 2017; Funderburk et al., 2021), we found high rates of treatment engagement (88%) and retention (76%) for MAST-V.”

• cites Cully et al., 2017 sourceSupported
• cites Funderburk et al., 2021 sourceNot checked — no full text of the source

Borderline on S1 (asserted), S3 (load-bearing), S4 (based): unclear from the text.

Participants attended more sessions in MAST-V than in usual care.

“Participants attended more sessions in MAST-V than usual care.”

May combine two claims.

Study therapists rated MAST-V as highly feasible, acceptable, and appropriate for PCBH.

“Study therapists achieved high treatment fidelity and rated MAST-V as highly feasible, acceptable, and appropriate for PCBH.”

May combine two claims.

Treatment satisfaction, credibility, and therapeutic alliance were higher for MAST-V than for usual care.

“Participants in both conditions valued treatment, but treatment satisfaction, credibility, and therapeutic alliance were higher for MAST-V.”

May combine two claims.

Five study therapists delivered 80 MAST-V sessions (mean 42 minutes) to 15 patients, with sessions occurring every 16 days on average.

“Overall, 5 study therapists delivered 80 MAST-V sessions (M = 42 [7] minutes duration) to 15 patients, with sessions occurring every 16 (8) days, on average.”

May combine two claims. The quote only partly states this claim.

Treatment satisfaction, treatment credibility, and therapeutic alliance were significantly higher for patients receiving MAST-V than for those receiving PCBH usual care (ps < .01).

“While acceptability was good for patients in both conditions on average, treatment satisfaction, treatment credibility, and therapeutic alliance were significantly higher for those receiving MAST-V (ps <. 01; see Figure 2).”

May combine two claims.

Study therapists rated MAST-V as highly acceptable (M = 4.8 out of 5) and appropriate for PCBH (M = 4.7 out of 5) on validated measures.

“Study therapists rated MAST-V as highly acceptable (M = 4.8 [0.4] out of 5) and appropriate for PCBH (M = 4.7 [0.4]) on validated measures.”

May combine two claims.

Skills covered in MAST-V modules were used infrequently (0-40% of sessions) and at small doses (0-5 minutes) in usual care.

“Skills covered in MAST-V modules were used infrequently (range: 0-40% of sessions) and at small doses (range: 0-5 minutes).”

May combine two claims.

OASIS scores decreased more from baseline for MAST-V than for PCBH usual care by 8 weeks, and the difference across conditions persisted through 12 and 16 weeks (ps < .05).

“OASIS scores decreased more from baseline for MAST-V than PCBH usual care by 8 weeks, and the difference across conditions persisted through 12 and 16 weeks (ps < .05; Supplementary Figure 1).”

May combine two claims.

By 4 weeks, mean OASIS scores for those receiving MAST-V dropped below the clinical cutoff, and by 12 weeks reflected a clinically significant decrease (≥4 points) from baseline.

“By 4 weeks, mean OASIS scores for those receiving MAST-V dropped below the clinical cutoff, and by 12 weeks, reflected a clinically significant decrease (≥4 points) from baseline.”

May combine two claims.

Of those who engaged in MAST-V treatment, 2 dropped out and 13 (87%) were retained completing the full treatment dose (≥4 sessions).

“Of those who engaged in treatment, 2 dropped out, whereas 13 (87%) were retained completing the full treatment dose (≥4 sessions).”

May combine two claims.

Six BHPs delivered 34 usual care sessions, mean duration 34 minutes, occurring on average every 20 days.

“Six BHPs delivered 34 sessions (M = 34 [11] minutes), which occurred on average every 20 (6) days.”

May combine two claims.

Skills training in usual care was more diffuse; most concepts covered in MAST-V skill modules were rarely or never delivered in usual care, and the dosage was limited.

“However, as in prior studies of CBT for anxiety, skills training in usual care was more diffuse (Higa-McMillan et al., 2016); for example, most concepts covered in MAST-V skill modules were rarely (e.g., mindfulness) or in one case, never (exposure), delivered in usual care, and the dosage was limited.”

• cites Higa-McMillan et al., 2016 sourceNot checked — no full text of the source

May combine two claims.

The study was a small pilot conducted at a single site using study therapists.

“This was a small pilot study at a single site using study therapists.”

May combine two claims.

MAST was developed to be evidence-based, transdiagnostic, patient-centered, and feasible for primary care settings like PCBH.

“Therefore, we developed a brief intervention, Modular Anxiety Skills Training (MAST), to be evidence-based, transdiagnostic, patient-centered, and feasible for primary care settings like PCBH (Shepardson et al., 2023b).”

• cites Shepardson et al., 2023bNot 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).

In the widely implemented PCBH model, behavioral health providers embedded in primary care deliver focused mental health treatment.

“In the widely implemented Primary Care Behavioral Health (PCBH) model, behavioral health providers (BHPs; e.g., psychologists, social workers) embedded in primary care deliver focused mental health treatment (Reiter et al., 2018).”

• cites Reiter et al., 2018 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Participants completed validated measures of anxiety symptoms and functional impairment at weeks 0, 4, 8, 12, and 16.

“Participants completed validated measures of anxiety symptoms and functional impairment at 0, 4, 8, 12, and 16 weeks.”

May combine two claims.

Data from both patients and therapists indicated high feasibility and acceptability, with high appeal of the modular approach.

“Consistent with our hypotheses and prior pilot work (Shepardson et al., 2023b), data from both patients and therapists indicated high feasibility and acceptability, with high appeal of the modular approach.”

• cites Shepardson et al., 2023bNot 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).

Cognitive impairment was assessed using a six-item screener.

“Cognitive impairment was assessed using a six-item screener (Callahan et al., 2002).”

• cites Callahan et al., 2002 sourceNot checked — no full text of the source

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

For GAD-7, analysis of covariance was used adjusting for baseline scores among complete cases.

“For GAD-7, we used analysis of covariance (ANCOVA) adjusting for baseline scores among complete cases.”

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

There were no changes in design, measures, or eligibility criteria during the trial, only in appointment modality.

“There were no changes in design, measures, or eligibility criteria during the trial, only in appointment modality.”

Classified as probably not a substantial claim.

Fidelity was assessed via observation using MAST-V session audiotapes rated by the first author and two trained research assistants using a fidelity checklist.

“Fidelity, comprising both adherence (delivering intended content) and competence (quality of delivery; Cross & West, 2011), was assessed via observation using MAST-V session audiotapes rated by the first author and two trained RAs using a fidelity checklist.”

May combine two claims.

Therapists reported high acceptability and appropriateness for PCBH across assessment methods, which reflects efforts during treatment development to anticipate implementation barriers and ensure flexibility and utility in real-world PCBH practice.

“Therapists reported high acceptability and appropriateness for PCBH across assessment methods, which we believe reflects efforts during treatment development to anticipate implementation barriers (Shepardson et al., 2023a) and ensure flexibility and utility in real-world PCBH practice (Shepardson et al., 2023b).”

• cites Shepardson et al., 2023aNot matched

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

• cites Shepardson et al., 2023bNot matched

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

Classified as probably not a substantial claim.

Intent-to-treat analyses were conducted to examine treatment effects by condition for a preliminary evaluation of effectiveness with alpha set at .05.

“We conducted intent-to-treat analyses to examine treatment effects by condition for a preliminary evaluation of effectiveness with alpha set at .05.”

May combine two claims.

Most BHPs receive at least some training in CBT, which provides a foundation for MAST-V.

“Most BHPs receive at least some training in CBT (Weissman et al., 2006), which provides a foundation for MAST-V.”

• cites Weissman et al., 2006 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Post-assessment assessors remained blinded to condition until all clinical measures were completed.

“Participants completed a brief telephone assessment (10 minutes, $10 each) every 4 weeks and a post-assessment at 16 weeks (90-120 minutes, $50) with assessors who were blinded to condition until all clinical measures were completed, at which time they opened an envelope revealing condition and administered condition-specific measures.”

Probably not a substantial claim: may not pass S3 (load-bearing). The quote only partly states this claim.

Less than 10% of data points were missing.

“For OASIS, which had 5 measurements, we used multilevel models (MLM) using SAS 9.4 Proc Mixed, which allows for incomplete trajectories under a missing at random premise; less than 10% (16/175) of data points were missing.”

May combine two claims.

In a pilot open trial with six participants, treatment retention and satisfaction were high.

“In a pilot open trial (N = 6), treatment retention and satisfaction were high, and participants showed large pre-post changes in clinical outcomes (Shepardson et al., 2023b); however, MAST needs rigorous evaluation.”

• cites Shepardson et al., 2023bNot 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.

The randomization scheme was prepared by the biostatistician, concealed from investigators and assessors in a password-protected electronic file, and followed by one unblinded research assistant who allocated participants.

“The randomization scheme was prepared by the biostatistician, concealed from investigators and assessors in a password-protected electronic file, and followed by one research assistant (RA) who was unblinded to allocate participants to condition.”

Classified as probably not a substantial claim.

Participants were randomized 1:1 to MAST-V or PCBH usual care using stratified random assignment in blocks of four based on baseline anxiety and depression severity.

“They were randomized 1:1 to either MAST-V or PCBH usual care using a stratified random assignment in blocks of four based on baseline anxiety severity (GAD-7 <15 vs ≥15) and depression severity (PHQ-9 <15 vs ≥15).”

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

Study therapists received weekly group supervision and feedback on session audiotapes.

“They received weekly group supervision and feedback on session audiotapes.”

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

The study was approved by the Syracuse VA Medical Center institutional review board and registered at clinicaltrials.gov with identifier NCT03794089.

“This study was approved by the Syracuse VA Medical Center institutional review board and registered at clinicaltrials.gov (NCT03794089).”

Classified as probably not a substantial claim.

Modular interventions allow patients to receive different components in different orders.

“Modular interventions allow patients to receive different components in different orders (Chorpita et al., 2005); in MAST, patients and BHPs collaboratively select modules based on patient needs/preferences and clinical recommendations.”

• cites Chorpita et al., 2005 sourceNot checked — no full text of the source

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

The study had hoped to recruit 40 participants but stopped after enrolling 35 due to pandemic-related recruitment delays and expiring funding.

“We had hoped to recruit 40 participants but had recruitment delays with the pandemic and, with funding expiring, stopped after enrolling 35.”

May combine two claims.

Fewer intervention participants (65%) completed the post-assessment than control participants (94%), Fisher's exact test p = .04.

“Fewer participants in the intervention condition (65%) completed the post-assessment compared to the control (94%, Fisher’s exact test p = .04).”

Classified as probably not a substantial claim.

Assessments were administered by research assistants blinded to condition.

“Assessments were administered by RAs blinded to condition.”

Classified as probably not a substantial claim.

To prevent contamination of usual care, MAST-V was delivered by study therapists.

“To prevent contamination of usual care, MAST-V was delivered by study therapists (n = 5, 40% female, 80% predoctoral interns, 20% postdoctoral fellows in psychology) with clinical experience in PCBH and training from the first author (five one-hour meetings and role play of initial session).”

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

For OASIS, multilevel models were used with SAS 9.4 Proc Mixed, allowing incomplete trajectories under a missing at random premise.

“For OASIS, which had 5 measurements, we used multilevel models (MLM) using SAS 9.4 Proc Mixed, which allows for incomplete trajectories under a missing at random premise; less than 10% (16/175) of data points were missing.”

• AssumptionThe authors state this as an assumption: The OASIS multilevel models rely on a missing at random premise.

May combine two claims.

No follow-up assessment was conducted to evaluate maintenance of gains or to formally assess whether participants met diagnostic criteria for anxiety disorders.

“We did not conduct a follow-up assessment to evaluate maintenance of gains or formally assess if participants met diagnostic criteria for anxiety disorders.”

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

Key methodological strengths include the hybrid I RCT design using a meaningful comparison condition delivering active treatment as usual, which was assessed for context.

“Key methodological strengths include the hybrid I RCT design using a meaningful comparison condition delivering active treatment as usual, which we assessed for context.”

May combine two claims.

Study therapists who had worked or were working in PCBH, rather than frontline BHPs, delivered MAST-V, with sessions occurring on average every 2.2 weeks versus 2.9 weeks in usual care.

“Study therapists who had worked or were working in PCBH, rather than frontline BHPs, delivered MAST-V, with sessions occurring on average every 2.2 weeks (vs. 2.9 weeks in usual care).”

May combine two claims.

Limitations include a single site with mostly White and male Veteran participants, which limits generalizability with respect to racial/ethnic minorities, women, and non-Veterans.

“Limitations include a single site with mostly White and male Veteran participants, which was consistent with clinic demographics, but limits generalizability with respect to racial/ethnic minorities, women, and non-Veterans.”

Probably not a substantial claim: may not pass S4 (based).

As a transdiagnostic intervention appropriate for a range of anxiety types and severity levels, including patients with comorbid concerns, MAST-V has a lower training burden compared to learning separate protocols by disorder.

“As a transdiagnostic intervention appropriate for a range of anxiety types and severity levels, including patients with comorbid concerns of low mood, poor sleep, or psychosocial stress, MAST-V has a lower training burden compared to learning separate protocols by disorder.”

May combine two claims.

This pilot trial demonstrated the feasibility and acceptability of a modular, transdiagnostic CBT intervention for anxiety in a PCBH setting.

“In conclusion, this pilot trial demonstrated the feasibility and acceptability of a modular, transdiagnostic CBT intervention for anxiety in a PCBH setting.”

May combine two claims.

Treatment engagement, retention, and satisfaction were very high, and participants showed clinically significant improvement in 6 or fewer sessions.

“Treatment engagement, retention, and satisfaction were very high, and participants showed clinically significant improvement in ≤6 sessions, which should give BHPs confidence in delivering this kind of intervention in PCBH.”

May combine two claims.

The sample size was small, and the pilot trial was not powered to demonstrate effectiveness; results should be considered preliminary until replicated in a larger trial.

“The sample size was small, and this pilot trial was not powered to demonstrate effectiveness; thus, results should be considered preliminary until replicated in a larger trial.”