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

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2024-04-14

Brief Summary

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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.

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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

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.

Interventions

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Digital ACT

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.

Intervention Type DEVICE

Eligibility Criteria

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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.