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

Swing Therapeutics

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Digital ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT05149222

Swing-003-EXT

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Digital Acceptance and Commitment Therapy (ACT) Arm

Other group

Description:

Pragmatic

Treatment:

Device: Digital ACT