"REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study

Swing Therapeutics, Inc.50 enrolled

Overview

This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

Digital ACTDEVICE

This is a virtual, single-arm, non-significant risk study. Study participants will receive 9 months of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant has completed participation in the REACT-FM study. * Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements. * Participant has provided informed consent to participate. * Participant continues to meet original safety criteria for the REACT-FM study. Exclusion Criteria: * None

Locations (1)

Swing Therapeutics

San Francisco, California, United States

Outcomes

Primary Outcomes

The primary efficacy endpoint is the response rate to 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: 9 months

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.