Background <p>Cognitive behavioral therapy (CBT) is an effective treatment for childhood anxiety disorders, but few affected children receive CBT in routine care. To improve access, we previously developed a primary care-adapted stepped-care CBT protocol (Step-by-Step).</p> Objective <p>The primary aim of this study was to assess the feasibility of the trial design in preparation for a multi-site randomized non-inferiority trial. Secondary aims included assessing treatment acceptability and exploring preliminary clinical outcomes.</p> Methods <p>In a two-site randomized pilot trial in Swedish primary care, 32 children aged 7–12 years were allocated to stepped-care CBT (Step-by-Step, <i>n</i> = 16) or standard CBT (Cool Kids, <i>n</i> = 16). Feasibility outcomes included recruitment rate, waiting time, completion of sessions and assessments, protocol adherence, and therapist hours. Acceptability was assessed via treatment credibility and satisfaction. Clinical outcomes were clinician-rated anxiety severity and child- and parent-reported anxiety and depression.</p> Results <p>Recruitment rate, waiting time, therapist adherence, and completion rates were acceptable. Therapist hours per patient were 35% lower in Step-by-Step (3.9&#xa0;h) compared to Cool Kids (6&#xa0;h). Both treatments were rated as credible and satisfactory. Clinician-rated anxiety severity decreased significantly within both treatments (within-group pre–post effects: Step-by-Step, Cohen’s <i>d</i> = 1.63, 95% CI [1.10, 2.15] and Cool Kids, Cohen’s <i>d</i> = 0.99, 95% CI [0.59, 1.39]).</p> Conclusions <p>Trial feasibility data support progression to a non-inferiority trial. A stepped-care CBT protocol delivered in primary care was well accepted by participants and showed preliminary within-group improvements in anxiety outcomes, while requiring less therapist time than standard CBT.</p> Trial Registration Number <p>NCT05686512, 17 January 2023.</p>

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Stepped-Care Cognitive Behavioral Therapy for Anxiety in Children in Primary Care: A Randomized Pilot Trial

  • Albin Isaksson,
  • Sigrid Elfström,
  • Johanna Engelbrektsson,
  • Livia van Leuven,
  • Henna Hasson,
  • Leif Eriksson,
  • Erik Hedman-Lagerlöf,
  • Johan Åhlén

摘要

Background

Cognitive behavioral therapy (CBT) is an effective treatment for childhood anxiety disorders, but few affected children receive CBT in routine care. To improve access, we previously developed a primary care-adapted stepped-care CBT protocol (Step-by-Step).

Objective

The primary aim of this study was to assess the feasibility of the trial design in preparation for a multi-site randomized non-inferiority trial. Secondary aims included assessing treatment acceptability and exploring preliminary clinical outcomes.

Methods

In a two-site randomized pilot trial in Swedish primary care, 32 children aged 7–12 years were allocated to stepped-care CBT (Step-by-Step, n = 16) or standard CBT (Cool Kids, n = 16). Feasibility outcomes included recruitment rate, waiting time, completion of sessions and assessments, protocol adherence, and therapist hours. Acceptability was assessed via treatment credibility and satisfaction. Clinical outcomes were clinician-rated anxiety severity and child- and parent-reported anxiety and depression.

Results

Recruitment rate, waiting time, therapist adherence, and completion rates were acceptable. Therapist hours per patient were 35% lower in Step-by-Step (3.9 h) compared to Cool Kids (6 h). Both treatments were rated as credible and satisfactory. Clinician-rated anxiety severity decreased significantly within both treatments (within-group pre–post effects: Step-by-Step, Cohen’s d = 1.63, 95% CI [1.10, 2.15] and Cool Kids, Cohen’s d = 0.99, 95% CI [0.59, 1.39]).

Conclusions

Trial feasibility data support progression to a non-inferiority trial. A stepped-care CBT protocol delivered in primary care was well accepted by participants and showed preliminary within-group improvements in anxiety outcomes, while requiring less therapist time than standard CBT.

Trial Registration Number

NCT05686512, 17 January 2023.