Virtual Patient Groups for Sarcoidosis Associated Fatigue (SupportSarc)

NeuroTherapia, Inc.

Status: Begins enrollment this month

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

Treatments: Behavioral: Virtual Mindfulness Based Cognitive Therapy 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 Cognitive Therapy (MBCT) can help reduce fatigue in people with sarcoidosis. The study will also look at whether MBCT 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 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.

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 MBCT intervention based on previous work showing improvement of sarcoidosis associated fatigue with a virtual MBCT intervention in the Netherlands.

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

8 week Virtual Mindfulness Based Cognitive Therapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Mindfulness Based Cognitive Therapy 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