Virtual Patient Groups for Sarcoidosis Associated Fatigue (SupportSarc)

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Sarcoidosis; Depression; Anxiety; Fatigue; Mental Health

Treatments: Behavioral: Virtual Mindfulness Based Stress Reduction Group; Behavioral: Virtual sarcoidosis support group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07073963

K23MD017284 (U.S. NIH Grant/Contract)

25-565

UM1TR004528 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

8 week Virtual Mindfulness Based Stress Reduction Group

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Mindfulness Based Stress Reduction Group

Monthly Virtual Sarcoidosis Support group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Virtual sarcoidosis support group