Cognitive‐behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof‐of‐concept for children and adolescents

The quote only partly states this claim.

ARFID severity scores on the Pica, ARFID, and Rumination Disorder Interview significantly decreased per both patient and parent report from pre- to post-treatment.

“ARFID severity scores (on the Pica, ARFID, and Rumination Disorder Interview) significantly decreased per both patient and parent report.”

May combine two claims.

Of 25 eligible individuals, 20 initiated treatment, including 17 completers and three dropouts.

“Of 25 eligible individuals, 20 initiated treatment, including 17 completers and three dropouts.”

May combine two claims.

Not all patients responded; three dropped out and 30% continued to meet criteria for ARFID.

“Of course, not all patients responded. Three dropped out and 30% continued to meet criteria for ARFID.”

May combine two claims.

Neither anxiety nor depression changed significantly during the course of treatment.

“Of note, neither anxiety nor depression changed significantly during the course of treatment.”

May combine two claims.

The underweight subgroup moved from approximately the 10th percentile to the 20th percentile for BMI from pre- to post-treatment (p < .001), a significant increase with large effect size.

“The underweight subgroup (n = 14) gained an average of 11.5 (SD = 6.0) pounds from pre- to post-treatment (p < .001), moving from approximately the 10th percentile to the 20th percentile for BMI (p < .001), representing a significant increase with a large effect size.”

May combine two claims.

A second adverse event was grade 1-2 (mild to moderate), related to the protocol, and involved mouth tingling after tasting nuts during a session in the sensory sensitivity module; the patient was referred to the emergency department, given epinephrine, and diagnosed with a nut allergy.

“In a second adverse event, rated as grade 1–2 (mild to moderate) and related to the protocol, a patient experienced mouth tingling after tasting nuts during a session in the sensory sensitivity module. We referred the second patient to the emergency department where the patient was given epinephrine and diagnosed with a nut allergy.”

May combine two claims.

Two non-completers were rated as having "no change" and a third as "minimally improved" on the CGI.

“Two non-completers were rated as having “no change” and a third as “minimally improved.””

May combine two claims.

One adverse event was grade 1 (mild), related to the protocol, and involved a patient vomiting involuntarily during an in-session interoceptive exposure in the lack of interest module.

“In the first adverse event, rated as grade 1 (mild) and related to the protocol, a patient vomited involuntarily during an in-session interoceptive exposure (i.e., drinking several cups of water to experience fullness) in the lack of interest module.”

May combine two claims.

Only three small randomized controlled trials of ARFID treatment have been published, and all have focused on young children ages 13 months to 12 years.

“Only three small randomized controlled trials have been published, and all have focused on young children ages 13 months to 12 years (Sharp et al., 2016; Sharp et al., 2017; Lock et al., 2019a).”

• cites Sharp et al., 2016Not checked yet

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• cites Sharp et al., 2017Not checked yet

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• cites Lock et al., 2019aNot checked yet

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May combine two claims.

Treatments for pediatric feeding disorders typically focus on infants, toddlers, and preschool children and include interventions that are not developmentally appropriate for older children or adolescents.

“Treatments for pediatric feeding disorders typically focus on infants, toddlers, and preschool children and include interventions that are not developmentally appropriate for older children or adolescents (e.g., Williams & Foxx, 2007).”

• cites Williams & Foxx, 2007Not checked yet

  Not checked in the free run.

May combine two claims.

Treatments for specific phobia target fear of choking or vomiting but lack interventions to promote weight gain or resolve nutrition deficiencies.

“Treatments for specific phobia target fear of choking (McNally, 1994) or vomiting (Hunter & Antony 2009), but lack interventions to promote weight gain or resolve nutrition deficiencies.”

• cites McNally, 1994Not checked yet

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• cites Hunter & Antony 2009Not checked yet

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

Therapists audio-recorded all sessions so that an independent PhD rater could make fidelity and competence ratings based on published measures.

“Therapists audio-recorded all sessions so that an independent PhD rater (REL) could make fidelity (ranging from 1—“not at all adherent” to 7—“completely adherent”) and competence (ranging from 1—“not at all” to 5—“completely”) ratings based on published measures (Thomas & Eddy, 2019).”

• cites Thomas & Eddy, 2019Not checked yet

  Not checked in the free run.

May combine two claims.

Findings provide evidence of feasibility, acceptability, and proof-of-concept for CBT-AR.

“Findings provide evidence of feasibility, acceptability, and proof-of-concept for CBT-AR.”

• AssumptionRests on an assumption: Improvements in ARFID symptoms, weight, and food variety observed from pre- to post-treatment are attributable to CBT-AR rather than to nonspecific factors, concurrent medical monitoring, or passage of time.
• AssumptionRests on an assumption: The sample of 20 patients who initiated treatment is representative of the broader population of children and adolescents with ARFID.
• AssumptionRests on an assumption: Therapists' post-treatment CGI ratings are unbiased by therapist allegiance or knowledge of treatment.
• AssumptionRests on an assumption: The number of new foods incorporated recorded by therapists is an accurate measure of patients' food incorporation.

May combine two claims.

CBT for eating disorders focuses on reducing shape and weight concerns, which are not central to ARFID.

“CBT for eating disorders focuses on reducing shape and weight concerns (Fairburn et al., 2008; Waller et al., 2019), which are not central to ARFID (Becker et al., 2019).”

• cites Fairburn et al., 2008Not checked yet

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• cites Waller et al., 2019Not checked yet

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• cites Becker et al., 2019Not checked yet

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

Research assistants who were not therapists in the trial conducted all assessments.

“Research assistants who were not therapists in the trial conducted all assessments.”

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

This is the first study of an outpatient manualized psychosocial treatment for ARFID in older adolescents.

“This is the first study of an outpatient manualized psychosocial treatment for ARFID in older adolescents.”

Classified as probably not a substantial claim.

The ORBIT model defines a proof-of-concept study as an uncontrolled within-subjects study that evaluates whether a novel intervention could plausibly offer clinically significant benefit that could later be evaluated in a randomized controlled trial.

“ORBIT defines a proof-of-concept study as an uncontrolled within-subjects study that evaluates whether a novel intervention could plausibly offer clinically significant benefit that could later be evaluated in a randomized controlled trial.”

• cites Czajkowski et al., 2015Not checked yet

  Not checked in the free run.

May combine two claims.

There are evidence-based outpatient protocols for psychiatric disorders that resemble ARFID-including pediatric feeding disorders, eating disorders, and anxiety disorders-but none is appropriate for ARFID specifically.

“There are evidence-based outpatient protocols for psychiatric disorders that resemble ARFID—including pediatric feeding disorders, eating disorders, and anxiety disorders—but none is appropriate for ARFID specifically.”

• cites Williams & Foxx, 2007Not checked yet

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• cites Fairburn et al., 2008Not checked yet

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• cites Waller et al., 2019Not checked yet

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

The study was registered at clinicaltrials.gov and approved by the Partners Human Research Committee prior to recruitment.

“The study was registered at www.clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT02963220) and approved by the Partners Human Research Committee prior to recruitment.”

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

The PARDI was administered by independent assessors who did not serve as study therapists.

“The PARDI was administered by independent assessors (MCK, JHJ, OBW, ACK) who did not serve as study therapists.”

May combine two claims.

CBT-AR demonstrated initial evidence of feasibility, acceptability, and proof-of-concept for children and adolescents in this uncontrolled trial.

“In conclusion, CBT-AR demonstrated initial evidence of feasibility, acceptability, and proof-of-concept for children and adolescents in this uncontrolled trial.”

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

Available data suggest that the low appetite reported by those with the lack of interest presentation of ARFID may be neurobiologically mediated.

“Indeed, available data suggest that the low appetite reported by those with the lack of interest presentation of ARFID may be neurobiologically mediated.”

• cites Becker et al., under reviewNot checked yet

  Not checked in the free run.

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

To the authors' knowledge, this is the first study of an outpatient psychosocial treatment for ARFID in older adolescents.

“To our knowledge, this is the first study of an outpatient psychosocial treatment for ARFID in older adolescents.”

May combine two claims.

The sample size was small, so p-values and effect sizes must be interpreted with caution.

“Second, the sample size was small, so p-values and effect sizes must be interpreted with caution.”

May combine two claims.

The initial study of 20 patients provides preliminary evidence for feasibility, acceptability, and proof-of-concept for CBT-AR in an outpatient sample of relatively mild severity.

“Our initial study of 20 patients provides preliminary evidence for feasibility, acceptability, and proof-of-concept for CBT-AR in an outpatient sample of relatively mild severity.”

May combine two claims.

The average pre-treatment STAIC and CDI-2 scores in the sample were near the mean for healthy individuals, suggesting little room for improvement.

“However, the average pre-treatment STAIC and CDI-2 scores in our sample were near the mean for healthy individuals, suggesting little room for improvement.”

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

The treatment was provided by one of three PhD therapists; two were authors of the treatment manual and the third was trained and supervised by the manual authors.

“The treatment was provided by one of three PhD therapists (JJT, KRB, or KTE). Two of the three therapists were the authors of the treatment manual and the third was trained and supervised by the manual authors.”

May combine two claims.

Cronbach alpha for PARDI severity was .65 for patients and .57 for parents.

“Cronbach alpha for severity was lower (.65 for patients and .57 for parents).”

May combine two claims.

Only two of the 20 participants received the individual version of CBT-AR, which limits the conclusions that can be drawn about proof-of-concept for this therapeutic format in youth.

“Lastly, only two of the 20 participants received the individual version of CBT-AR, which limits the conclusions that can be drawn about proof-of-concept for this therapeutic format in youth.”

May combine two claims.

By both patient- and parent-report, ARFID severity and sensory sensitivity showed significant reductions, whereas patients but not parents reported significant reductions in lack of interest in eating or food.

“It is notable that, by both patient- and parent- report, ARFID severity and sensory sensitivity showed significant reductions, whereas patients (but not parents) reported significant reductions in lack of interest in eating or food.”

Classified as probably not a substantial claim.

The ORBIT model of intervention development suggests that successful proof-of-concept studies be followed up with randomized controlled trials.

“The ORBIT model of intervention development suggests that successful proof-of-concept studies be followed up with randomized controlled trials (Czajkowski et al., 2015).”

• cites Czajkowski et al., 2015Not checked yet

  Not checked in the free run.

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

Study therapists met weekly for peer supervision.

“Study therapists met weekly for peer supervision.”

May combine two claims.

The results extend upon the prior study by demonstrating positive effects of CBT in a larger sample and highlighting that CBT may lead to significant symptom reduction even when delivered in a less time-intensive and more cost-effective weekly outpatient format.

“However, our results extend upon the prior study by demonstrating positive effects of CBT in a larger sample and highlighting that CBT may lead to significant symptom reduction even when delivered in a less time-intensive and more cost-effective weekly outpatient format.”

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

Cronbach alpha was .94 for the FNS in the current sample.

“Cronbach alpha was .94 for the current sample.”

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

Both patients who experienced adverse events remained in treatment, suggesting they may have been willing to experience some discomfort for the possibility of reducing ARFID symptoms.

“Of note, both patients who experienced adverse events remained in the treatment, suggesting that they may have been willing to experience some discomfort for the possibility of reducing ARFID symptoms.”

May combine two claims.

Given that the majority of patients received the family-supported version of CBT-AR, the findings are consistent with recent case series and one pilot RCT of young children that reported positive effects of FBT for ARFID.

“Given that the majority of patients in our study received the family-supported version of CBT-AR, our findings are also consistent with recent case series (Lock et al., 2019b; Rienecke et al., 2020) and one pilot RCT of young children (Lock et al., 2019a) that have reported positive effects of FBT for ARFID.”

• cites Lock et al., 2019bNot checked yet

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• cites Rienecke et al., 2020Not checked yet

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• cites Lock et al., 2019aNot checked yet

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

The primary outcome measure-the PARDI interview-was conducted by assessors who were not therapists in the current study.

“Second, the primary outcome measure—the PARDI interview—was conducted by assessors who were not therapists in the current study.”

May combine two claims.

Therapists delivered CBT-AR according to a published manual and exhibited high levels of treatment fidelity as confirmed by an independent rater.

“First, therapists delivered CBT-AR according to a published manual and exhibited high levels of treatment fidelity as confirmed by an independent rater.”

May combine two claims.

Because patients were recruited from a larger neurobiology study, they had to meet inclusion criteria (e.g., ability to complete MRI) that would not normally be applied in routine clinical care and were offered monetary compensation for completing assessments, which could limit generalizability of the findings.

“Fourth, because we recruited our sample from a larger neurobiology study of ARFID, patients had to meet some inclusion criteria (e.g., ability to complete MRI) that would not normally be applied in routine clinical care and were offered monetary compensation for completing assessments, which could limit generalizability of the findings.”

May combine two claims.

Pre-treatment PARDI scores were fairly low, which may limit generalizability to those with more severe presentations.

“Third, pre-treatment PARDI scores were fairly low, which may limit generalizability to those with more severe presentations.”

Classified as probably not a substantial claim.

Patients were not allowed to receive any other interventions-such as nutrition counseling, occupational therapy, speech therapy, or other forms of psychotherapy-during the trial.

“Patients were not allowed to receive any other interventions—such as nutrition counseling, occupational therapy, speech therapy, or other forms of psychotherapy—during the trial.”

May combine two claims.

Patients and families rated CBT-AR as credible upon starting treatment and satisfactory upon completing it.

“Patients and families rated CBT-AR as credible upon starting treatment and satisfactory upon completing it.”

May combine two claims.

The majority of patients offered CBT-AR elected to take it up, and few patients dropped out.

“Specifically, the majority of patients offered the treatment elected to take it up, and few patients dropped out.”

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

Cronbach alpha was .85 for the STAIC trait subscale in the current sample.

“Cronbach alpha was .85 in the current sample.”

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

Cronbach alpha was .72 for the CDI-2 in the current sample.

“Cronbach alpha was .72 in the current sample.”

May combine two claims.

Therapists, patients, and parents reported significant improvements on multiple measures of ARFID symptoms, ranging from incorporation of new foods to significant gains in weight.

“Therapists, patients, and parents reported significant improvements on multiple measures of ARFID symptoms, ranging from the incorporation of new foods to significant gains in weight.”