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Hidradenitis Suppurativa (HS)NCT07903948

Pilot MBSR for People With HS

A study testing Mindfulness-Based Stress Reduction in people with Hidradenitis Suppurativa (HS), run by University of California, San Francisco at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Hidradenitis suppurativa (HS) is a chronic inflammatory condition that causes painful, recurring abscesses and nodules. It is associated with psychological stress and impaired quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
Mindfulness-Based Stress Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
10 Aug 2026to 4 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Living with hidradenitis suppurativa (HS), diagnosed by a dermatologist
  • Able to read, write, and speak English
  • Access to a device with Internet access

Who cannot join

  • Lacks reliable access to the Internet or device (e.g., phone, tablet, laptop/computer) to participate in study activities
  • Unable to confirm HS diagnosis by a dermatologist

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: Pilot Single Arm Acceptability Study of Mindfulness-Based Stress Reduction for Individuals With Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic inflammatory condition that causes painful, recurring abscesses and nodules. It is associated with psychological stress and impaired quality of life. Our study aims to pilot a mindfulness-based stress reduction program tailored to patients with HS, then use their feedback to improve the program.

Read the detailed description

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by painful skin abscesses, nodules, and scarring. Patients with HS experience significant psychological distress and difficulty coping with disease-related stigma, social isolation, and the daily burden of symptoms, including chronic pain.

Mindfulness-Based Stress Reduction (MBSR) has demonstrated improvements to psychological distress and chronic pain among patients with chronic inflammatory diseases. However, the standard MBSR course may be challenging for individuals with HS due to the location of painful skin lesions in body fold areas and may not adequately address HS-specific stressors.

Our study will adapt the MBSR intervention for HS using a synthesis of published literature on HS-related stressors and coping strategies, participant feedback, and the expertise of a certified MBSR instructor. The intervention will be delivered virtually over Zoom and evaluated through surveys and focus group discussions.

Being tested
Mindfulness-Based Stress Reduction
Keywords
Hidradenitis Suppurativa, Mindfulness-Based Stress Reduction
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Stress ReductionBehavioural

    Also called MBSR

    An 8-week structured educational program delivered entirely online over Zoom. Participants will meet once weekly for 2.5 hours each session and participate in one seven-hour guided retreat between weeks 6 and 7. All classes include didactic content and mindfulness practices. There is also weekly home-based practice in between sessions. Adaptations include centering group discussion on HS, modifications to the sequence that mindfulness practices are introduced in the program, and options for shorter duration of mindfulness practices.

Study groups in NCT07903948
Study groupRoleWhat they receive
Intervention ArmExperimentalMindfulness-Based Stress Reduction
Receives: Behavioral: Mindfulness-Based Stress Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of MBSR for Individuals with HS as Assessed by the Acceptability of Intervention Measure (AIM)

    This tool measures the acceptability of a given intervention. Questions range from 1 to 4. The total score range is 4 to 20. Higher scores indicate greater acceptability of the intervention.

    Measured: 8 weeks

  2. Acceptability of MBSR for Individuals with HS as Assessed by the Theoretical Framework of Acceptability (TFA)

    This tool measures the acceptability of a given intervention and has been adapted to fit the needs of our HS study. This tool has 7 Constructs + 1 General Acceptability Construct, however we did not include the Ethical construct due ambiguity regarding the applicability of the construct to the study (i.e., 6 Constructs + 1 General Acceptability Construct). Questions range from 1 and 5. The total mean score range for our adapted TFA is 6 to 30, and for the General acceptability item is 1 to 5. Higher scores indicate greater acceptability of the intervention.

    Measured: 8 weeks

Secondary outcomes (3)

  1. Intervention Adherence as Assessed by MBSR Course Attendance

    Intervention adherence will be measured by the percentage of participants who attended at least six of the eight group sessions.

    Measured: 8 weeks

  2. Study Retention as Assessed by the Percent of Participants who Complete the Study

    Study retention will be measured by the number of participants who completed survey assessments at the 8-week follow-up time-point divided by the number of participants who enrolled in the study, multiplied by 100.

    Measured: 8 weeks

  3. Feasibility of MBSR for Individuals with HS as Assessed by the Feasibility of Intervention Measure (FIM)

    This tool measures the feasibility of a given intervention. Questions range from 1 to 4. The total score range is 4 to 20. Higher scores indicate greater feasibility of the intervention.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start10 Aug 2026
  3. Primary completion25 Nov 2026 (estimated)
  4. Study completion4 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07903948
Sponsor's protocol ID
26-46414
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

    PubMed 24395196

  • Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

    PubMed 27002445

  • Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.

    PubMed 15256293

  • Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.

    PubMed 3897551

  • Kirby JS, Sisic M, Tan J. Exploring Coping Strategies for Patients With Hidradenitis Suppurativa. JAMA Dermatol. 2016 Oct 1;152(10):1166-1167. doi: 10.1001/jamadermatol.2016.1942. No abstract available.

    PubMed 27304616

  • Esmann S, Jemec GB. Psychosocial impact of hidradenitis suppurativa: a qualitative study. Acta Derm Venereol. 2011 May;91(3):328-32. doi: 10.2340/00015555-1082.

    PubMed 21394419

  • Butt M, Sisic M, Silva C, Naik HB, Esmann S, Jemec G, Kirby JS. The associations of depression and coping methods on health-related quality of life for those with hidradenitis suppurativa. J Am Acad Dermatol. 2019 Apr;80(4):1137-1139. doi: 10.1016/j.jaad.2018.09.045. No abstract available.

    PubMed 30876533

  • Machado MO, Stergiopoulos V, Maes M, Kurdyak PA, Lin PY, Wang LJ, Shyu YC, Firth J, Koyanagi A, Solmi M, Alavi A, Piguet V, Carvalho AF. Depression and Anxiety in Adults With Hidradenitis Suppurativa: A Systematic Review and Meta-analysis. JAMA Dermatol. 2019 Aug 1;155(8):939-945. doi: 10.1001/jamadermatol.2019.0759.

    PubMed 31166590

  • Kimball AB, Kirby J, Ingram JR, Tran T, Pansar I, Ciaravino V, Willems D, Lewis-Mikhael AM, Tongbram V, Garg A. Burden of Hidradenitis Suppurativa: A Systematic Literature Review of Patient Reported Outcomes. Dermatol Ther (Heidelb). 2024 Jan;14(1):83-98. doi: 10.1007/s13555-023-01085-w. Epub 2024 Jan 6.

    PubMed 38183616

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Stress Reduction in people with Hidradenitis Suppurativa (HS), run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of MBSR for Individuals with HS as Assessed by the Acceptability of Intervention Measure (AIM) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07903948, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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