Treatment - Mindfulness & Acceptance
Yifei Dai, Ph.D.
Head of Clinical and Scientific Affairs
Swing Therapeutics
gainesville, Florida
Zunera Ghalib, B.S.
CRA II
Swing Therapeutics
San Francisco, California
Allison C. Kraus, M.A.
Data Scientist & Technical Operations
Swing Therapeutics
San Francisco, California
Nicolette Vega, B.A.
Sr. Clinical Project Manager
Swing Therapeutics, Inc.
San Mateo, California
Michael Gendreau, M.D., Ph.D.
Managing Partner
Gendreau Consulting LLC
Poway, California
Michael Rosenbluth, Ph.D.
Founder and CEO
Swing Therapeutics
San Francisco, California
Lance McCracken, Ph.D.
Professor of Clinical Psychology
Department of Psychology, Uppsala University
Uppsala, Uppsala Lan, Sweden
Juan Luciano, Ph.D.
Sr Lecturer
Universitat Autónoma de Barcelona
Barcelona, Catalonia, Spain
Brian Keefe, M.D.
Consultant
Swing Therapeutics
San Francisco, California
Andrea Chadwick, M.D.
Associate Professor
University of Kansas
Kansas City, Kansas
Fibromyalgia (FM) is a chronic pain disorder with complex and individually heterogeneous clinical presentations of symptoms, including chronic widespread pain, fatigue, sleep disruption and other issues. Investigations of FM treatments are generally based on population level improvement, without regard to the specific symptoms that matter the most to individuals. As patient-centered health care is gaining more recognition, appraisals of FM treatments should also examine their ability to address individual patients’ clinical needs. This study sought to 1) identify symptoms that limit the quality of life (QoL) of individual FM patients; and 2) evaluate the effectiveness of a smartphone-based digital acceptance and commitment therapy program for FM management (FM-ACT) in addressing clinical needs at the individual patient level.FM patients were enrolled into a single-arm real-world trial and received 12 weeks of FM-ACT treatment. Prior to treatment, each patient was surveyed to identify their top 3 QoL limiting symptoms (clinical needs) from a list of common FM symptoms. The corresponding clinical measures were analyzed at the end of the 12-week treatment, including fatigue (BDI-II “tiredness and fatigue” item), cognitive function (FIQ-R “memory” item, BDI-II “concentration” item), physical function (FIQ-R function domain), anxiety (GAD-7), depression (BDI-II total), as well as numeric rating scales (NRSs) on pain intensity, pain interference, and sleep interference. Post-treatment outcomes among patients associated with each clinical need was assessed. Patients’ QoL at week 12 was compared to the baseline to assess post-treatment improvement.One hundred and eight participants were enrolled at the analysis time. The top 3 ranked symptoms/clinical needs, based on the proportion of participants reporting, were fatigue (74%), cognitive dysfunction (60%), and pain interference (58%), followed by physical dysfunction, pain intensity, sleep interference, anxiety, and depression. Sixty-two participants had completed the study with week 12 outcome data available at the time of analysis. Among them, 87% of participants showed symptom improvement in at least one of their identified clinical needs. Specifically, 73% of participants who listed pain interference as a QoL limiting symptom experienced improvement, along with 71% of participants who cited cognitive function and 52% of those who listed fatigue. Similar improvements were observed among groups identified with lower ranked clinical needs, ranging from 54% (pain intensity) to 90% (physical function). QoL ratings were improved in 58% of the participants. Half (51%) of the initially dissatisfied patients reported satisfactory QoL after completion of the treatment. This study specifically elicited FM symptoms that individual patients found most distressing and examined rates of improvement following FM-ACT treatment. The results showed that FM-ACT addressed the specific clinical needs in most FM patients studied, which may contribute to the observed QoL improvements. These findings reinforced the previously published cohort-level positive outcomes of FM-ACT and the importance of accounting for patient-level clinical needs in delivering modern healthcare.