A Multisite, Pilot and Feasibility Randomized Controlled Trial to Improve Cardiometabolic Health in Adolescent Girls with Elevated Anxiety (Preprint)

BACKGROUND Anxiety is common in adolescents at risk for excess weight gain and implicated in poorer cardiometabolic health, partially through disinhibited eating. Therefore, reducing anxiety in adolescents may improve disinhibited eating patterns and prevent worsening cardiometabolic health. OBJECTIVE The aim of this pilot trial was to assess the feasibility and acceptability of a study protocol involving randomization to one of two virtual, group psychological interventions targeting reduction in anxiety to improve cardiometabolic health in adolescent girls with elevated anxiety and above-average weight. METHODS This two-site, pilot and feasibility randomized controlled trial enrolled 12-17-year girls with elevated anxiety symptoms (State-Trait Anxiety Inventory for Children Total Score ≥32) and above-average weight (body mass index [BMI; kg/m2] ≥75th percentile for age/sex), in good general health. Girls were randomly assigned to either 12-week, virtual group interpersonal psychotherapy (IPT) or 12-week, virtual group cognitive-behavioral therapy (CBT). Anxiety, disinhibited eating, BMI indices, blood pressure, lipids, HbA1c, and fasting glucose were measured at baseline, 12-week follow-up, and one-year follow-up. Feasibility of recruitment, retention, and study protocol, and acceptability and fidelity of IPT and CBT were evaluated. RESULTS Of adolescents deemed eligible via screening, 79% enrolled. Enrollment of the total sample (N=40) was completed in 7 months. Retention was 85% in IPT and 90% in CBT at 12-week follow-up and 85% in both arms at one-year follow-up. Adherence to standard operating procedures was >96% for all intervals. Data missingness was variable, with larger missingness (up to 35%) for phlebotomy. Most adolescents received ≥80% intervention dosage (IPT: 90%; CBT: 95%), and acceptability ratings were above-average for likeability (M±SD 3.03±1.14) and credibility (3.26±.75; 0-4 scale with 4=Highest) across arms. Expert fidelity ratings of IPT were 78±11% and of CBT were 94±9%. Anxiety, disinhibited eating behavior, BMI percentile, and multiple cardiometabolic health indicators improved from baseline to one-year follow-up within both arms. CONCLUSIONS IPT and CBT virtual group programs show feasible recruitment, retention through one-year follow up, and acceptable attendance, likeability, and credibility to adolescent girls experiencing anxiety and above-average weight. Comparative efficacy of IPT and CBT for improving BMI and cardiometabolic health indicators in adolescents with elevated anxiety and above-average weight warrants testing. CLINICALTRIAL NCT05038033