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

NCT ID: NCT05433337

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2024-03-05

Brief Summary

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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.

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 device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), 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

Group Type OTHER

Digital ACT

Intervention Type DEVICE

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

Interventions

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Digital ACT

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

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

22 Years

Maximum Eligible Age

75 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-005-EXT

Identifier Type: -

Identifier Source: org_study_id

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