Virtual Patient Groups for Sarcoidosis Associated Fatigue
NCT ID: NCT07073963
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-01-01
2027-03-01
Brief Summary
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Participants will be placed into one of two groups:
* One group will take part in an 8-week virtual MBCT 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 6 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.
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Detailed Description
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Participants will be adults diagnosed with sarcoidosis per ATS criteria 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, FAS assessment, and online screener survey.
Following enrollment, participants will be randomized 1:1 to either the MBCT intervention or control group (support group). The MBCT intervention consists of 8 weekly, virtual group sessions led by trained facilitators and includes guided mindfulness practices, cognitive exercises, 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-MBCT), 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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8 week Virtual Mindfulness Based Cognitive Therapy Group
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.
Virtual Mindfulness Based Cognitive Therapy Group
Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week, group-based psychological intervention that integrates principles of cognitive behavioral therapy (CBT) with training in mindfulness meditation. The intervention is designed to help participants develop greater awareness of thoughts, emotions, and bodily sensations, with the goal of preventing depressive relapse and reducing psychological distress. Each weekly session includes guided mindfulness practices (e.g., body scan, sitting meditation, mindful movement), group discussion, and cognitive-behavioral exercises focused on recognizing and disengaging from unhelpful thought patterns. Participants are assigned daily home practice using audio recordings and written materials. The MBCT intervention will be delivered over a video platform for this trial.
Monthly Virtual Sarcoidosis Support group
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.
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 illness care. No home practice is required.
Interventions
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Virtual Mindfulness Based Cognitive Therapy Group
Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week, group-based psychological intervention that integrates principles of cognitive behavioral therapy (CBT) with training in mindfulness meditation. The intervention is designed to help participants develop greater awareness of thoughts, emotions, and bodily sensations, with the goal of preventing depressive relapse and reducing psychological distress. Each weekly session includes guided mindfulness practices (e.g., body scan, sitting meditation, mindful movement), group discussion, and cognitive-behavioral exercises focused on recognizing and disengaging from unhelpful thought patterns. Participants are assigned daily home practice using audio recordings and written materials. The MBCT intervention will be delivered over a video platform for this trial.
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 illness care. No home practice is required.
Eligibility Criteria
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Inclusion Criteria
* Fatigue defined as FAS score ≥ 22
* Age ≥ 18 years old
* Ability to speak and read English
* Access to internet
* Capacity to consent
Exclusion Criteria
* 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 online screening questionnaire and screening interview)
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; discomfort participating in a group-based intervention, drug use
* Lack of interest in study participation (assessed by online screening questionnaire).
* Lack of access to any form of online video access
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Clinical and Translational Science Collaborative of Northern Ohio
UNKNOWN
National Center for Advancing Translational Sciences (NCATS)
NIH
The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Logan J Harper, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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