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

PROSPER-FM-EXT: Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05433337

Acronym

PROSPER-FM-EXT

Enrollment

Registered

2022-06-27

Start date

2022-06-08

Completion date

2024-03-05

Last updated

2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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.

Interventions

DEVICEDigital ACT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

22 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Global Impression of Change (PGIC)	Month 9	PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Secondary

Measure	Time frame	Description
Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score	Original Study Baseline to Month 9	FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026