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Virtual Patient Groups for Sarcoidosis Associated Fatigue

ConditionsSarcoidosisFatigueDepressionAnxietyMental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self reported diagnosis of sarcoidosis

Fatigue defined as FAS score ≥ 22

Age ≥ 18 years old

Ability to speak and read English

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 8 week Virtual Mindfulness Based Stress Reduction GroupExperimental treatment 1 intervention
Group B: Monthly Virtual Sarcoidosis Support groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PROMIS Fatigue 8a

validated 8 items fatigue questionnaire reported as an aggregate score

Time frame
From enrollment to the end of the study period at 5 months

Secondary outcomes

1

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.

Time frame
From enrollment to end of study period at 5 months
2

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

Time frame
From enrollment to end of study period at 5 months
3

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.

Time frame
From enrollment to end of study period at 5 months

Other outcomes

1

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

Time frame
From enrollment to end of study period at 5 months
2

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.

Time frame
From enrollment to end of study period at 5 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov
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