Virtual groups to reduce sarcoidosis-related fatigue
Virtual Patient Groups for Sarcoidosis Associated Fatigue
This project tests whether an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program can help reduce fatigue and improve anxiety and depression in adults with sarcoidosis compared with a monthly virtual support group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07073963 on ClinicalTrials.gov |
What this trial studies
Adults with self-reported sarcoidosis and significant fatigue (FAS ≥22) are randomized 1:1 to an 8-week virtual MBSR program with weekly online sessions, daily mindfulness journaling, and home practice, or to an existing monthly virtual sarcoidosis support group for five months. Outcomes on fatigue, anxiety, and depression are measured with online surveys at baseline, 8 weeks, and 5 months. The trial excludes people with a current daily meditation practice or prior formal mindfulness-based therapy and requires English proficiency and internet access. Recruitment is led by Cleveland Clinic using both virtual and in-person strategies.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with self-reported sarcoidosis who have significant fatigue (FAS score ≥22), can read and speak English, have reliable internet access, and do not currently practice daily meditation or have prior formal mindfulness training.
Not a fit: Patients with a current daily meditation practice, prior formal mindfulness-based therapy, lack of online video access, or conditions that preclude safe group participation (including active suicidal ideation) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the MBSR program could offer adults with sarcoidosis a practical, non-drug option to reduce fatigue and improve mental well-being.
How similar studies have performed: Smaller prior studies of mindfulness interventions for sarcoidosis-associated fatigue have suggested benefit, but large randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self reported diagnosis of sarcoidosis * Fatigue defined as FAS score ≥ 22 * Age ≥ 18 years old * Ability to speak and read English * Access to internet * Capacity to consent Exclusion Criteria: * Current daily meditation practice * Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy * Any condition that would prevent being a suitable candidate for the group intervention (as determined by screening interview) including suicidal ideation. * Lack of access to any form of online video access
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Logan J Harper, MD — The Cleveland Clinic
- Study coordinator: Tiana Powell
- Email: powellt@ccf.org
- Phone: 216-308-5111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.