Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial
Open accessAbstract
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.
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One study reported potential conflict of interest, with many authors being paid consultants, shareholders and/or employees of the company which produced the app used to administer ACT, and funded the study.
“One study reported potential conflict of interest, with many of the authors being paid consultants, shareholders and/or employees of the company which produced the app used to administer ACT, and funded the study. 25”
From The efficacy, acceptability and safety of acceptance and commitment therapy for fibromyalgia – a systematic review and meta-analysis (2024) · cites this paper as [25]
The Introduction identifies Swing Therapeutics as the company behind the Stanza app used to deliver ACT. The passages from our copy do not substantiate the claim that many authors were paid consultants, shareholders, or employees, or that the company funded the study; searches for conflict-of-interest and funding disclosures did not locate those details. (LLM, conf=0.76)
Experimental — accuracy not yet measuredThe PACT app achieved high engagement levels similar to other digital ACT interventions.
“This suggests that the PACT app achieved high engagement levels similar to other digital ACT interventions (Catella et al., Citation2024).”
From Evaluating a digital mental health intervention for people with Parkinson's (PACT): acceptability and feasibility randomised controlled trial. (2025) · cites this paper as Catella et al., 2024
The Results (Treatment adherence) report that FM-ACT participants completed a mean of 71 sessions, and the Discussion describes engagement as very high. The Discussion does not say engagement was similar to digital ACT interventions generally: it reports lower engagement in other digital behavioral therapy programs and says FM-ACT reached a level typically seen with therapist-delivered guidance. (LLM, conf=0.86)
Experimental — accuracy not yet measured
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- Authors
- Catella, S., Gendreau, R. M., Kraus, A. C., Vega, N., Rosenbluth, M. J., Soefje, S., Malhotra, S., Luciano, J. V., McCracken, L. M., Williams, D. A., & Arnold, L. M.
- Affiliations
- Excell Research (United States) (US)
- Universitat Autònoma de Barcelona (ES)
- Uppsala University (SE)
- University of Michigan (US)
- University of Cincinnati (US)
- Corresponding author
- Catella, Stephanie
- ORCID
- Venue
- Journal of Behavioral Medicine
- Published
- 2023-06-29
- Volume
- 47
- Issue
- 1
- Pages
- 27-42
- ISSN
- 0160-7715 (ISSN-L)
- 1573-3521
- PMC
- PMC10867073
- OpenAlex
- W4382502644
- Cited by
- 23
- References
- 54
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 7 · 2023: 1
- FWCI
- 4.68
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Journal of Behavioral Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by)
- Funders
- Swing Therapeutics, Inc. (Swing Therapeutics, Inc.)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- fibromyalgia, acceptance and commitment therapy, digital health, symptom monitoring, treatment engagement, attrition, feasibility, virtual clinical trials
- MeSH terms
- Behavior Therapy, Female, Fibromyalgia, Humans, Male, Middle Aged, Surveys and Questionnaires, Treatment Outcome, Acceptance and Commitment Therapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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