Abstract
OBJECTIVE: Certain treatments have demonstrated acute efficacy for binge-eating disorder (BED) but many patients who receive "evidence-based" interventions do not derive sufficient benefit. Given the dearth of controlled research examining treatments for patients who fail to respond to initial interventions, this study tested the efficacy of cognitive-behavioral therapy (CBT) for patients with BED who do not respond to initial acute treatments. METHODS: Prospective randomized double-blind placebo-controlled single-site trial, conducted August 2017-December 2021, tested 16-weeks of therapist-led CBT for non-responders to initial treatment (naltrexone/bupropion and/or behavioral therapy) for BED with obesity. Thirty-one patients (mean age 46.3 years, 77.4% women, 80.6% White, mean BMI 38.99 kg/m(2) ) who were non-responders to initial acute treatments were randomized to CBT (N = 18) or no-CBT (N = 13), in addition to continuing double-blinded pharmacotherapy. Independent assessments were performed at baseline, throughout treatment, and posttreatment; 83.9% completed posttreatment assessments. RESULTS: Intention-to-treat remission rates were significantly higher for CBT (61.1%; N = 11/18) than no-CBT (7.7%; N = 1/13). Mixed models of binge-eating frequency (assessed using complementary methods) converged revealing a significant interaction between CBT and time and a significant main effect of CBT. Binge-eating frequency decreased significantly with CBT but did not change significantly with no-CBT. Since only four patients received behavioral treatment during the acute treatments, we performed "sensitivity-type" analyses restricted to the 27 patients who received pharmacotherapy during the acute treatment and found the same pattern of findings for CBT versus no-CBT. CONCLUSIONS: Adult patients with BED who fail to respond to initial pharmacological treatments should be offered CBT. PUBLIC SIGNIFICANCE: Even with leading evidence-based treatments for binge-eating disorder, many patients do not derive sufficient benefit. Almost no controlled research has examined treatments for patients who fail to respond to initial interventions. This study found that that cognitive-behavioral therapy was effective for patients with binge-eating disorder who did not respond to initial interventions, with 61% achieving abstinence.