Virtual Patient Groups for Sarcoidosis

(SupportSarc Trial)

Overseen By Logan J Harper, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Psychosis, Mania, Personality disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Mindfulness-Based Cognitive Therapy (MBCT), a mental health treatment, can reduce fatigue and improve anxiety and depression in individuals with sarcoidosis, a condition causing lumps of inflammatory cells in the body. Participants will either join an 8-week virtual mindfulness program or a monthly virtual sarcoidosis support group to compare effectiveness in managing symptoms. Ideal candidates are those diagnosed with sarcoidosis who experience significant fatigue and have internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance symptom management for sarcoidosis.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these virtual programs are safe for participants with sarcoidosis?

Research shows that mindfulness-based cognitive therapy (MBCT) is generally safe. Studies have found that patients with sarcoidosis who used online MBCT experienced reduced fatigue, anxiety, and depression. These studies reported no serious side effects, indicating that the therapy is well-tolerated. As a virtual program, it involves no medications or physical procedures, reducing the risk of side effects. This makes MBCT a low-risk option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Mindfulness Based Cognitive Therapy Group for sarcoidosis because it offers a fresh approach to managing fatigue and mental health, which are significant concerns for patients. Unlike standard treatments that might focus on medication or physical therapy, this therapy emphasizes mindfulness techniques to improve mental well-being and reduce fatigue. The virtual format also provides a convenient and accessible way for patients to engage in therapy from the comfort of their homes, which is a significant advantage for those with limited mobility or access to healthcare facilities.

What evidence suggests that this trial's treatments could be effective for sarcoidosis?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT) can help reduce tiredness in people with sarcoidosis. In this trial, participants in the 8-week Virtual Mindfulness-Based Cognitive Therapy Group will meet weekly with a certified counselor to learn and practice mindfulness techniques. Studies have found that a 12-week online MBCT program can improve tiredness, anxiety, depression, and overall health in these patients. Another study discovered that even just one 45-minute session of mindfulness training could help lessen tiredness. These findings suggest that MBCT could be a promising way to improve mental well-being and manage tiredness in those with sarcoidosis. ^{1 2 6 7 8}

Who Is on the Research Team?

Logan J Harper, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with sarcoidosis experiencing fatigue, who may also have symptoms of anxiety or depression. Participants should be willing to engage in virtual sessions and complete surveys. Specific eligibility criteria are not provided.

Inclusion Criteria

Meets ATS criteria diagnosis for sarcoidosis (as determined by recruiting physician)

I often feel very tired.

Ability to speak and read English

Exclusion Criteria

I practice meditation every day.

Any condition that would prevent being a suitable candidate for the group intervention (as determined by online screening questionnaire and screening interview)

I have participated in mindfulness or therapy programs like MBSR or DBT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Treatment

Participants receive either an 8-week virtual MBCT program or join a monthly virtual support group

8 weeks

8 weekly virtual sessions for MBCT group; 1 monthly virtual session for support group

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Surveys at 8 weeks and 5 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Mindfulness Based Cognitive Therapy Group
• Virtual sarcoidosis support group

Trial Overview The study compares two virtual interventions: an 8-week Mindfulness-Based Cognitive Therapy (MBCT) program with weekly sessions and daily journaling, versus a monthly sarcoidosis support group for 6 months. Both groups will survey their fatigue, anxiety, and depression levels.

How Is the Trial Designed?

Group I: 8 week Virtual Mindfulness Based Cognitive Therapy Group Experimental Treatment 1 Intervention

This group will meet with a certified Mindfulness Based Cognitive Therapy 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 Cognitive Therapy techniques for the duration of the 8 week intervention and complete fatigue, depression, and anxiety surveys at time 0, 8 weeks, and 5 months.

Group II: Monthly Virtual Sarcoidosis Support group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Clinical and Translational Science Collaborative of Northern Ohio

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260022003873

Online mindfulness-based cognitive therapy for fatigue in ... One study suggested that a 45-min single session of mindfulness-based training could improve fatigue in sarcoidosis, and one cohort study in 14 patients ...

2. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(22)00387-3/abstract

Online mindfulness-based cognitive therapy for fatigue in ... 12 week eMBCT improves fatigue, anxiety, depression, mindfulness, and health status in patients with sarcoidosis-associated fatigue. Funding.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36427515/

Online mindfulness-based cognitive therapy for fatigue in ... 12 week eMBCT improves fatigue, anxiety, depression, mindfulness, and health status in patients with sarcoidosis-associated fatigue.

4. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2022.205.1_MeetingAbstracts.A4781?download=true

Online Mindfulness Based Cognitive Behavioral Therapy ... Thus, eMCBT is an effective treatment for fatigue in patients with sarcoidosis, and as it is online, it can be easily integrated in daily ...

5. research.tilburguniversity.edu research.tilburguniversity.edu/files/97893449/65732858.pdf

Online mindfulness-based cognitive therapy for fatigue in ... One study suggested that a 45-min single session of mindfulness-based training could improve fatigue in sarcoidosis, and one cohort study in 14 ...

6. ctv.veeva.com ctv.veeva.com/study/virtual-patient-groups-for-sarcoidosis-associated-fatigue

Virtual Patient Groups for Sarcoidosis Associated Fatigue This research study is testing whether Mindfulness-Based Cognitive Therapy (MBCT) can help reduce fatigue in people with sarcoidosis.

7. hcplive.com hcplive.com/view/sarcoidosis-associated-symptoms-improve-mindfulness-cognitive-therapy

Sarcoidosis-Associated Symptoms Improve With ... Patients with sarcoidosis who practiced online mindfulness-based cognitive therapy (eMBCT) showed improvements in fatigue, anxiety, ...

8. withpower.com withpower.com/trial/phase-depression-8-2025-5df7e

Virtual Patient Groups for Sarcoidosis (SupportSarc Trial) This research study is testing whether Mindfulness-Based Cognitive Therapy (MBCT) can help reduce fatigue in people with sarcoidosis.