Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23MD017284 | U.S. NIH Grant/Contract | View source | |
| UM1TR004528 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
The goal is to see which approach is more helpful for improving fatigue and mental well-being in people with sarcoidosis.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of study period at 5 months |
| Patient Health Questionnaire - 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Five Facet of Mindfulness Scale (Short Form; FFMQ-15) | The FFMQ is a measure of treatment fidelity. The FFMQ measures pre-post trait mindfulness and is assessed using 15 items that index the degree to which participants experience daily mindfulness, a central objective of MBSR treatment. Each item is rated on a 5-point scale from '1' = never or very rarely true to '5' = very often or always true. Reported as a single aggregate score |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiana Powell | Contact | 216-308-5111 | powellt@ccf.org | |
| Logan J Harper, MD | Contact | 216-444-0013 | harperl3@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Logan J Harper, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D005221 | Fatigue |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| 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. | From enrollment to end of study period at 5 months |
| From enrollment to end of study period at 5 months |
| Client Satisfaction Questionnaire (CSQ-8) | The CSQ-8 is a validated questionnaire of patients satisfaction with mental health interventions. It involves summing response to 8 questions on a 4 point scale with scores ranging from 8 to 32. | From enrollment to end of study period at 5 months |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |