Recruiting

MBSR

Sponsor:

The Cleveland Clinic

Code:

NCT07073963

Conditions

Sarcoidosis

Fatigue

Depression

Anxiety

Mental Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Mindfulness Based Stress Reduction Group

Virtual sarcoidosis support group

Study Details

Brief summary:

This research study is testing whether Mindfulness-Based Stress Reduction (MBSR) can help reduce fatigue in people with sarcoidosis. The study will also look at whether MBSR can improve symptoms of anxiety and depression.

Participants will be placed into one of two groups:

  • One group will take part in an 8-week virtual MBSR program, attend weekly online sessions, keep a daily mindfulness journal, and complete surveys about fatigue, anxiety, and depression.
  • The other group will join a virtual support group once a month for 5 months and complete the same surveys.

The goal is to see which approach is more helpful for improving fatigue and mental well-being in people with sarcoidosis.

Conditions

Sarcoidosis

Fatigue

Depression

Anxiety

Mental Health

Study ID

NCT07073963

Start date

Feb 26, 2026

Status verified date

Feb, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 8 week Virtual Mindfulness Based Stress Reduction Group

This group will meet with a certified Mindfulness Based Stress Reduction counselor one time a week to learn and practice mindfulness techniques as a means of addressing fatigue and mental health in sarcoidosis. This group will fill out diaries of their use of Mindfulness Based Stress Reduction techniques for the duration of the 8 week intervention and complete fatigue, depression, and anxiety surveys at time 0, 8 weeks, and 5 months.

active comparator: Monthly Virtual Sarcoidosis Support group

This group will be invited to join an existing virtual sarcoidosis support group. They will participate in the group for the 5 months of the trial. They will complete fatigue, depression, and anxiety surveys at time 0, 8 weeks, and 5 months.

Interventions

Virtual Mindfulness Based Stress Reduction Group

Mindfulness Based Stress Reduction is an evidence-based, manualized 8-week group program designed to improve coping with chronic physical and psychological symptoms. MBSR emphasizes mindfulness meditation, body awareness, and gentle movement to cultivate nonjudgmental awareness of present-moment experiences and reduce stress reactivity. The intervention will be delivered in a virtual group setting.

Virtual sarcoidosis support group

Participants attend a once-monthly, virtual support group via secure video conferencing. Each session includes a brief didactic presentation on topics relevant to living with chronic illness (e.g., symptom management, coping strategies, navigating healthcare) followed by a facilitated group discussion. The discussion emphasizes peer support, shared experiences, and emotional processing in a safe, respectful environment. Groups are led by an experienced facilitator with experience in chronic illness care. No home practice is required.

Primary outcome measure

  • PROMIS Fatigue 8a [ Time Frame: From enrollment to the end of the study period at 5 months ]

Central Contacts and Locations

Central contacts

Tiana Powell

216-308-5111powellt@ccf.org

Logan J Harper, MD

216-444-0013harperl3@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Tiana Powell

216-308-5111powellt@ccf.org

Logan Harper, MD

216-444-0013harperl3@ccf.org

Principal Investigator:

Logan Harper, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Apr 24, 2026

Last verified

Feb, 2026

Keywords

  • mindfulness
  • support group
  • virtual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-04-24.