"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia

NCT ID: NCT05011162

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-25

Study Completion Date

2024-03-05

Brief Summary

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The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a virtual, single-arm, pragmatic, non-significant risk study.

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Acceptance and Commitment Therapy (ACT) Arm

Pragmatic

Group Type OTHER

Digital ACT

Intervention Type DEVICE

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

Interventions

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Digital ACT

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Participant is 22 years of age or older
2. Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
3. Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).

Exclusion Criteria

1. Participant is not a resident of the United States
2. In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
3. Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swing Therapeutics, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Keefe, MD

Role: PRINCIPAL_INVESTIGATOR

Swing Therapeutics

Locations

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Swing Therapeutics

San Francisco, California, United States

Site Status

Countries

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United States

Related Links

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https://www.swingtherapeutics.com/

Swing Therapeutics Website

Other Identifiers

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Swing-003

Identifier Type: -

Identifier Source: org_study_id

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