The Effectiveness of Integrated Group Therapy Based on Mindfulness and Acceptance and Commitment Therapy (ACT) on Quality of Life and Reduction of Perceived Stress in Patients with Hidradenitis Suppurativa
Effects of Mindfulness- and ACT-Based Group Therapy on Quality of Life and Perceived Stress in Patients with Hidradenitis Suppurativa
Design
Open-label, controlled, parallel-group clinical trial (30 patients). Quality of life and perceived stress are assessed before and after the intervention
Settings and conduct
An open-label, controlled clinical trial in 30 patients with Hidradenitis Suppurativa assigned to intervention and control groups. Quality of life and perceived stress are assessed before and after the intervention.
Participants/Inclusion and exclusion criteria
Confirmed diagnosis of Hidradenitis Suppurativa, age 18–60 years, disease duration of at least one year, willingness to participate in the study, and no concurrent psychological intervention.
Intervention groups
Intervention group: 15 patients receiving Mindfulness- and Acceptance and Commitment Therapy (ACT)-based group therapy plus routine care.
Control group: 15 patients receiving routine care only.
Main outcome variables
The independent variable is Mindfulness- and Acceptance and Commitment Therapy (ACT)-based group therapy. The dependent variables are quality of life and perceived stress, measured using the WHOQOL-BREF and PSS questionnaires. Age, confirmed diagnosis of Hidradenitis Suppurativa, and disease duration are also recorded.
General information
Reason for update
Acronym
MACT-HS
IRCT registration information
IRCT registration number:IRCT20260704070062N1
Registration date:2026-07-20, 1405/04/29
Registration timing:registered_while_recruiting
Last update:2026-07-20, 1405/04/29
Update count:0
Registration date
2026-07-20, 1405/04/29
Registrant information
Name
Fatemeh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 3541
Email address
f.hosseini@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
2026-05-22, 1405/03/01
Actual recruitment end date
2026-12-21, 1405/09/30
Trial completion date
2027-01-20, 1405/10/30
Scientific title
The Effectiveness of Integrated Group Therapy Based on Mindfulness and Acceptance and Commitment Therapy (ACT) on Quality of Life and Reduction of Perceived Stress in Patients with Hidradenitis Suppurativa
Public title
Effect of Mindfulness- and Acceptance and Commitment-Based Group Therapy on Quality of Life and Stress in Patients with Hidradenitis Suppurativa
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Confirmed diagnosis of **Hidradenitis Suppurativa**
Disease duration of at least one year
Willingness and written informed consent to participate in the Acceptance and Commitment Therapy (ACT)-based treatment sessions
Not receiving any other form of psychotherapeutic intervention during the study period
Age between 18 and 60 years.
Exclusion criteria:
Participation in any psychological intervention within at least 6 months prior to enrollment in the study.
Absence from more than two treatment sessions.
Inability or unwillingness to complete the study assessments due to fatigue.
Withdrawal of consent or unwillingness to continue participation in the study.
Incomplete questionnaire responses.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Campus, University of Tehran, Jalalieh, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2026-01-18, 1404/10/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.702
Health conditions studied
1
Description of health condition studied
Hidradenitis suppurativa
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and after completion of the intervention
Method of measurement
Measured using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Secondary outcomes
1
Description
Perceived stress
Timepoint
Before the intervention and after completion of the intervention
Method of measurement
Measured using the Perceived Stress Scale (PSS)
Intervention groups
1
Description
Intervention group: Fifteen patients with Hidradenitis Suppurativa receiving Mindfulness- and Acceptance and Commitment Therapy (ACT)-based group therapy plus routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Zeinab Aryanian
Street address
Islamic Unity Street, below Islamic Unity Square, District 12, Tehran, Tehran Province, Iran,
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Fax
Email
name@domain.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
6th Floor, Vice Presidency of Research and Technology Central Administration Building, Tehran University Keshavarz Blvd., at the corner of Qods St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
PhD Candidate of Biostatistics
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
No. 12, Unit 2, Ferdows Alley, Mirjalili St., Qazvin St., South Karegar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1335765453
Phone
+98 21 5540 3541
Email
f.hosseini@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
PhD Candidate of Biostatistics
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
No. 12, Unit 2, Ferdows Alley, Mirjalili St., Qazvin St., South Karegar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13357655453
Phone
+98 21 5540 3541
Email
f.hosseini@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
PhD Candidate of Biostatistics
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
No. 12, Unit 2, Ferdows Alley, Mirjalili St., Qazvin St., South Karegar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1335765453
Phone
+98 21 5540 3541
Email
f.hosseini@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual Participant Data (IPD) will not be shared because it contains confidential patient information. To protect participants' privacy and maintain confidentiality, these data will not be made publicly available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available