Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial

Abstract

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.

Keywords: Acceptance and Commitment Therapy; Chronic pain; Digital ACT; Fibromyalgia; Prescription digital therapeutic; Smartphone-delivered ACT; Smartphone-delivered CBT.

Fig. 1

Treatment Application Design. (A) Screenshot of the FM-ACT digital program showing one of the ACT exercises included in the self-guided program. (B) Screenshot of the FM-ST active control showing the daily symptom score monitoring display

Fig. 2

Consolidated Standards of Reporting Trials Flow Diagram Outlining Study Enrollment, Treatment Allocation, and Populations Analyzed. Patients were enrolled from 28 October 2020 to 14 April 2021. The final study assessments occurred on the study completion date of 12 July 2021. ^aThe 39 patients lost to screen failures did not meet the enrollment and/or randomization criteria. ^bParticipants were excluded from the FM-ACT PP population due to study withdrawal (n = 2), failure to complete ≥ 41 FM-ACT sessions (n = 2), unallowed medication changes (n = 1), or failure to meet the amended enrollment criteria (FIQ-R total score ≥ 35) (n = 1). ^cParticipants were excluded from the FM-ST PP population due to study withdrawal (n = 1), or failure to complete ≥ 41 FM-ST sessions (n = 2).

Fig. 3

Preliminary Efficacy Analyses Based on FIQ-R Total Scores. The LS mean change from baseline to Week 12 in FIQ-R total scores is shown by treatment arm for the ITT population (A) and the PP population (B). Error bars represent the standard error of the mean. The percentage of participants who reported ≥ 20% improvement from baseline to Week 12 in FIQ-R total scores is shown by treatment arm for the ITT population (C) and the PP population (D)

Fig. 4

PGIC Responder Analysis at Week 12. The percentages of participants who responded “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, or “Much Worse” at Week 12 are shown by treatment arm for the ITT population. No participants reported “Very Much Worse”