Virtual Patient Groups for Sarcoidosis Associated Fatigue

Overview

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.

Detailed description

Fatigue is a common and debilitating symptom of sarcoidosis. There are currently no approved treatments for sarcoidosis associated fatigue. We are testing an MBSR intervention based on previous work showing improvement of sarcoidosis associated fatigue with mindfulness interventions.

Participants will be adults diagnosed with sarcoidosis per self report and experiencing significant fatigue (Fatigue Assessment Scale \[FAS\] score ≥22). Participants will be recruited through Cleveland Clinic and partnering sarcoidosis clinics. Recruitment includes both in-person and virtual strategies using electronic health record (EHR) screening, MyChart messages, clinician referrals, and self-referral through a recruitment letter. Interested patients will complete eligibility screening, including a virtual or in-person consent process and FAS assessment.

Following enrollment, participants will be randomized 1:1 to either the MBSR intervention or control group (support group). The MBSR intervention consists of 8 weekly, virtual group sessions led by trained facilitators and includes guided mindfulness practices, group discussions, and home practice assignments. The control group will participate in an existing monthly virtual sarcoidosis support group, which includes a brief educational presentation and group discussion.

Study outcomes will be collected using online surveys at three timepoints: baseline (prior to intervention), 8 weeks (immediately post-MBSR), and 5 months (3-month follow-up). Outcomes include fatigue (primary), quality of life, depression, and anxiety. Qualitative interviews will be conducted after the intervention to explore participant experiences with the intervention.

The investigators will conduct an interim analysis to determine feasibility of study for study participants. If there is greater than 30% drop out and drop out assessed by primary investigator, blinded to study results, is determined to be due to intervention components, the study will be paused, the intervention tailored prior to continued recruitment.

Interventions

• Behavioral 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.
• Behavioral 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 illn

Primary outcome measures

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

Secondary outcome measures (3)

• Kings Sarcoidosis Questionnaire - General Health [Time frame: From enrollment to end of study period at 5 months]
• Patient Health Questionnaire - 8 [Time frame: From enrollment to end of study period at 5 months]
• Generalized Anxiety Disorder-7 [Time frame: From enrollment to end of study period at 5 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Cleveland Clinic — Cleveland

Identifiers

NCT: NCT07073963 · 25-565 · K23MD017284 · UM1TR004528

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗