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Randomized Controlled Trial
. 2021 Mar:230:62-70.e3.
doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.

Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial

Natoshia R Cunningham  1 , Anne Kalomiris  2 , James Peugh  3 , Michael Farrell  4 , Scott Pentiuk  4 , Daniel Mallon  4 , Christine Le  2 , Erin Moorman  2 , Lauren Fussner  2 , Richa Aggarwal Dutta  2 , Susmita Kashikar-Zuck  3
Affiliations
Randomized Controlled Trial

Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial

Natoshia R Cunningham et al. J Pediatr. 2021 Mar.

Abstract

Objectives: To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy, the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety.

Study design: Eligible patients between the ages of 9 and 14 years with functional abdominal pain disorders (n = 139) received enhanced usual care during their medical visit to a gastroenterologist. Those that failed to respond to enhanced usual care were randomized to receive either a tailored cognitive behavioral therapy (ADAPT) plus medical treatment as usual, or medical treatment as usual only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT plus medical treatment as usual vs medical treatment as usual on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored.

Results: Based on recruitment and retention rates, stepped care was feasible. Enhanced usual care was effective for only 8% of youth. Participants randomized to ADAPT plus medical treatment as usual showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to medical treatment as usual only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain.

Conclusions: Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care.

Trial registration: ClinicalTrials.gov: NCT03134950.

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Figures

Figure 1.
Figure 1.
Consort Study Diagram. Two hundred and three children were approached, 139 were enrolled, and 110 remained eligible for stepped-up care after rescreening. Of those, 89 were randomized to ADAPT + TAU (n = 40 completing) or medical treatment as usual (TAU; n = 39 completing).
Figure 2.
Figure 2.
Functional disability inventory (FDI) scores from screening to re-screening generally remained within the moderate range of disability. After randomization to ADAPT + TAU or TAU, both groups experienced a reduction in FDI scores, with the ADAPT+TAU group experiencing the most pronounced improvement. The ADAPT+TAU group had significantly lower FDI scores at post compared with the TAU group.
Figure 3.
Figure 3.
Average scores on the Visual Analog Scale (VAS) for pain remained in the moderate range from screening to baseline. At post assessment, both ADAPT+TAU and TAU groups experienced a reduction in pain symptoms. For ADAPT+TAU completers, the reduction in pain symptoms was clinically significant but was not statistically different compared with those completing TAU.
Figure 4 (online).
Figure 4 (online).
Patients with FAPD generally presented with clinically elevated levels of anxiety. Those who completed ADAPT+TAU were more likely to have statistically and clinically significant reductions in anxiety symptoms at post-assessment. Note: The SCARED was not readministered at baseline because scores are valid for 3 months following administration.
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