A Psychological Intervention with Virtual Reality-Based Exposure and Exercise Training to Reduce Social Physique Anxiety in Women with Obesity: A Feasibility Randomized Controlled Trial

This feasibility randomized controlled trial: (i) assessed the feasibility and acceptability of a cognitive-behavioral therapy intervention with virtual reality-based exposure plus exercise training (CBTVR+ET) in women with obesity and study protocol, and (ii) provided SPA data to inform a future full-scale trial. Forty-five women with obesity were randomized to: (i) CBTVR+ET, (ii) a psychological supportive intervention plus exercise training, or (iii) a waitlist group. Feasibility data (e.g. recruitment, retention, attendance) were compared against predetermined targets. Acceptability was assessed via questionnaires and interviews. SPA was measured with questionnaires at baseline, post intervention, and six-month follow-up. Over a 19-month, 8.4 participants were recruited monthly. Retention was 86.7% (two dropouts per group). Attendance rates were ≥ 85 % for psychological and exercise sessions. All feasibility targets were met. Acceptability data were positive, though interviews identified areas requiring refinement. To report on critical parameters needed for the future trial, SPA scores in the CBTVR+ET group were 37.3±5.1 and 30.8±6.4 at baseline and post-intervention, respectively (Hedge’s g=-1.13), with baseline-post correlation of r=0.567 across groups. The intervention and study methods are viable for a full-scale trial, pending revisions. A definitive trial is warranted to provide robust efficacy evidence for this intervention addressing SPA in women with obesity.