Virtual Patient Groups for Sarcoidosis Associated Fatigue

NCT07073963 | Recruiting

• 3 other identifiers: 25-565K23MD017284UM1TR004528
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

mindfulness; support group; virtual

Outcome Measures

Primary Outcomes (1)

• PROMIS Fatigue 8a

  validated 8 items fatigue questionnaire reported as an aggregate score

  From enrollment to the end of the study period at 5 months

Secondary Outcomes (3)

• Kings Sarcoidosis Questionnaire - General Health

  From enrollment to end of study period at 5 months

• Patient Health Questionnaire - 8

  From enrollment to end of study period at 5 months

• Generalized Anxiety Disorder-7

  From enrollment to end of study period at 5 months

Other Outcomes (2)

• Five Facet of Mindfulness Scale (Short Form; FFMQ-15)

  From enrollment to end of study period at 5 months

• Client Satisfaction Questionnaire (CSQ-8)

  From enrollment to end of study period at 5 months

Study Arms (2)

8 week Virtual Mindfulness Based Stress Reduction Group

EXPERIMENTAL

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.

Behavioral: Virtual Mindfulness Based Stress Reduction Group

Monthly Virtual Sarcoidosis Support group

ACTIVE COMPARATOR

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.

Behavioral: Virtual sarcoidosis support group

Interventions

Virtual Mindfulness Based Stress Reduction Group BEHAVIORAL

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.

8 week Virtual Mindfulness Based Stress Reduction Group

Virtual sarcoidosis support group BEHAVIORAL

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.

Monthly Virtual Sarcoidosis Support group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• The Cleveland Clinic: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Fatigue; Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Logan J Harper, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiana Powell

CONTACT

216-308-5111; powellt@ccf.org

Logan J Harper, MD

CONTACT

216-444-0013; harperl3@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 20, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)