SarcoidosisSupportSarcNCT07073963
Virtual Patient Groups for Sarcoidosis Associated Fatigue
A study testing Virtual Mindfulness Based Stress Reduction Group and Virtual sarcoidosis support group in people with Sarcoidosis and Fatigue, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Fatigue, Depression
- What is being tested?
- Virtual Mindfulness Based Stress Reduction Group and Virtual sarcoidosis support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Tiana Powell, 216-308-5111, powellt@ccf.org
Logan Harper, MD, 216-444-0013, harperl3@ccf.org
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis, Fatigue, Depression, Anxiety, Mental Health
- Being tested
- Virtual Mindfulness Based Stress Reduction Group, Virtual sarcoidosis support group
- Keywords
- mindfulness, support group, virtual
- Medical subject headings
- Sarcoidosis, Fatigue, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Mindfulness Based Stress Reduction GroupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual sarcoidosis support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Fatigue 8a
validated 8 items fatigue questionnaire reported as an aggregate score
Measured: From enrollment to the end of the study period at 5 months
Secondary outcomes (3)
Kings Sarcoidosis Questionnaire - General Health
The KSQ General Health is a 10-item self-report survey reported as a single aggregate score which assesses quality of life in sarcoidosis.
Measured: From enrollment to end of study period at 5 months
Patient Health Questionnaire - 8
It is a self-reported measure of depressive symptom severity and consists of items consistent with criteria for DSM-based diagnosis. PHQ-8 scores range from 0 to 24. Each of the 8 items can be scored from 0 ("not at all") to 3 ("nearly every day"). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively. The construct validity of the PHQ-8 has been demonstrated in a wide range of patient populations
Measured: From enrollment to end of study period at 5 months
Generalized Anxiety Disorder-7
7-item questionnaire that measures frequency of anxiety symptoms over the past 7 days. Response options are scored on a 4-point Likert scale ranging from "not at all" to "nearly every day." The summed score will be reported.
Measured: From enrollment to end of study period at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start26 Feb 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Logan J Harper, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073963
- Sponsor's protocol ID
- 25-565
- Other IDs
- K23MD017284, UM1TR004528
- Acronym
- SupportSarc
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Patient Groups for Sarcoidosis Associated Fatigue
- ClinicalTrials.gov ID
- NCT07073963
- Acronym / sponsor ID
- SupportSarc / 25-565
- Conditions
- Sarcoidosis, Fatigue, Depression, Anxiety, Mental Health
- Keywords
- mindfulness, support group, virtual
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 week Virtual Mindfulness Based Stress Reduction Group | Experimental | Behavioral: Virtual Mindfulness Based Stress Reduction GroupThis 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. |
| Monthly Virtual Sarcoidosis Support group | Active comparator | Behavioral: Virtual sarcoidosis support groupThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self reported diagnosis of sarcoidosis
- Fatigue defined as FAS score ≥ 22
- Age ≥ 18 years old
- Ability to speak and read English
- Access to internet
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Mindfulness Based Stress Reduction GroupMindfulness 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. | Behavioural | 8 week Virtual Mindfulness Based Stress Reduction Group |
| Virtual sarcoidosis support groupParticipants 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. | Behavioural | Monthly Virtual Sarcoidosis Support group |
Primary outcome
PROMIS Fatigue 8a
Time frame: From enrollment to the end of the study period at 5 months
validated 8 items fatigue questionnaire reported as an aggregate score
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Logan J Harper, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Mindfulness Based Stress Reduction Group and Virtual sarcoidosis support group in people with Sarcoidosis and Fatigue, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiana Powell (216-308-5111, powellt@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Fatigue 8a (time frame: From enrollment to the end of the study period at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.