Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

Swing Therapeutics, Inc.60 enrolled

Overview

This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

Digital ACTDEVICE

Study participants will continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia

Eligibility

Sex: ALLMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm * Participant is willing and able to comply with all protocol-specified requirements Key Exclusion Criteria: * Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study * Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II) * Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study

Locations (1)

Swing Therapeutics

San Francisco, California, United States

Outcomes

Primary Outcomes

Patient Global Impression of Change (PGIC)

PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Time frame: Month 9

Secondary Outcomes

Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.

Time frame: Original Study Baseline to Month 9

Data from ClinicalTrials.gov

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