Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial
Por:
Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA and Arnold LM
Publicada:
29 jun 2023
Ahead of Print:
1 jun 2023
Resumen:
Although empirically validated for fibromyalgia (FM), cognitive and behavioral therapies, including Acceptance and Commitment Therapy (ACT), are inaccessible to many patients. A self-guided, smartphone-based ACT program would significantly improve accessibility. The SMART-FM study assessed the feasibility of conducting a predominantly virtual clinical trial in an FM population in addition to evaluating preliminary evidence for the safety and efficacy of a digital ACT program for FM (FM-ACT). Sixty-seven patients with FM were randomized to 12 weeks of FM-ACT (n = 39) or digital symptom tracking (FM-ST; n = 28). The study population was 98.5% female, with an average age of 53 years and an average baseline FM symptom severity score of 8 out of 11. Endpoints included the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) and the Patient Global Impression of Change (PGIC). The between-arm effect size for the change from baseline to Week 12 in FIQ-R total scores was d = 0.44 (least-squares mean difference, - 5.7; SE, 3.16; 95% CI, - 11.9 to 0.6; P = .074). At Week 12, 73.0% of FM-ACT participants reported improvement on the PGIC versus 22.2% of FM-ST participants (P < .001). FM-ACT demonstrated improved outcomes compared to FM-ST, with high engagement and low attrition in both arms. Retrospectively registered at ClinicalTrials.gov (NCT05005351) on August 13, 2021.
Filiaciones:
Catella S:
Swing Therapeutics, Inc, San Francisco, CA, USA.
Gendreau RM:
Gendreau Consulting, LLC, Poway, CA, USA
Kraus AC:
Swing Therapeutics, Inc, San Francisco, CA, USA
Vega N:
Swing Therapeutics, Inc, San Francisco, CA, USA
Rosenbluth MJ:
Swing Therapeutics, Inc, San Francisco, CA, USA
Soefje S:
Excell Research, Inc, Oceanside, CA, USA
Malhotra S:
Neuro-Behavioral Clinical Research, Inc, North Canton, OH, USA
Luciano JV:
Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Barcelona, Spain
Teaching, Research & Innovation Unit, Parc Santari Sant Joan de Déu, St. Boi de Llobregat, Spain
McCracken LM:
Department of Psychology, Uppsala University, Uppsala, Sweden
Williams DA:
Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA
Arnold LM:
Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH, USA
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