The effectiveness of acceptance and commitment therapy (ACT) on improving quality of life, reducing symptoms of anxiety and depression, and enhancing psychological flexibility in patients with psoriasis.
Investigating the effectiveness of Acceptance and Commitment Therapy (ACT) on improving quality of life, reducing anxiety and depression, and enhancing cognitive flexibility in patients with psoriasis.
Design
This study is designed as a pilot quasi-experimental trial with parallel groups (intervention and control) conducted on 60 patients (30 participants in each group). Participants will be selected through convenience sampling, and allocation into the two groups will be performed using simple randomization with SPSS software. This study is designed as a pilot trial (preliminary phase).
Settings and conduct
Study setting: Dermatology department of Imam Reza Hospital in Amol city;
Study population: patients with psoriasis;
Type of blinding: single-blind;
Blinding method: the data analyst was unaware of the participants’ group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 40 years; ability to read and write; providing informed consent to participate in the study.
Exclusion criteria: Diagnosis of severe psychiatric disorders based on medical records or psychiatrist evaluation; receiving concurrent similar psychological interventions at the time of enrollment.
Intervention groups
In the intervention group, Acceptance and Commitment Therapy (ACT) was delivered in eight in-person group sessions, each lasting 60 minutes, including instruction on ACT principles, mindfulness exercises, and homework assignments.
In the control group, no intervention was provided during the study period; however, after the completion of the experimental sessions, ACT training was offered to them remotely (online).
Main outcome variables
Quality of life score on the DLQI scale; Anxiety score on the HADS scale; Depression score on the HADS scale; Cognitive flexibility score on the CFI scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251008067556N1
Registration date:2026-06-08, 1405/03/18
Registration timing:prospective
Last update:2026-06-08, 1405/03/18
Update count:0
Registration date
2026-06-08, 1405/03/18
Registrant information
Name
Mahta Abdoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4324 5936
Email address
mhta.abdoli98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-20, 1405/03/30
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy (ACT) on improving quality of life, reducing symptoms of anxiety and depression, and enhancing psychological flexibility in patients with psoriasis.
Public title
Evaluating the effectiveness of Acceptance and Commitment Therapy (ACT) in patients with psoriasis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of psoriasis skin disease according to a physician's diagnosis
Age range between 20-40 years
Reading and writing
The willingness and consent of consciousness to enter the research project
Exclusion criteria:
Diagnosis of severe psychiatric disorders based on medical records or psychiatrist evaluation.
Receiving concurrent similar psychological interventions at the time of enrollment.
Unwillingness to participate in the study or failure to provide informed consent.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be allocated into intervention and control groups using a simple randomization method based on a random numbers table in SPSS software. First, the list of eligible participants will be entered into SPSS software. Then, a random variable with uniform distribution will be generated using the following command:
Compute Random = RV.UNIFORM(0,1)
After generating the random variable, the data will be sorted from the smallest to the largest random number, and participants will be assigned to the intervention and control groups according to the resulting order.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given the nature of the intervention (Acceptance and Commitment Therapy), complete blinding was not feasible, as both the therapist and participants were aware of the type of intervention. However, to minimize bias in the data analysis process, partial (single) blinding was implemented; that is, the individual responsible for data entry and statistical analysis was unaware of group assignments (experimental or control).
Furthermore, participants were not informed about the exact research hypothesis or the expected outcomes to prevent the occurrence of the expectancy effect.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ayatollah Amoli University of Science and Research
Before the intervention and after completion of the treatment sessions
Method of measurement
Measured using the Dermatology Life Quality Index (DLQI)
2
Description
Anxiety level in patients with psoriasis
Timepoint
Before the intervention and after completion of the treatment sessions
Method of measurement
Measured using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS‑A)
3
Description
Depression level in patients with psoriasis
Timepoint
Before the intervention and after completion of the treatment sessions
Method of measurement
Measured using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS‑D)
4
Description
Cognitive flexibility in patients with psoriasis
Timepoint
Before the intervention and after completion of the treatment sessions
Method of measurement
Measured using the Cognitive Flexibility Inventory (CFI) by Dennis & Vander Wal
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receives Acceptance and Commitment Therapy (ACT) in a face-to-face, group format. The intervention consists of eight 60‑minute group sessions delivered over eight weeks (one session per week). Session content is based on the six core ACT processes and includes: theoretical education, acceptance exercises, cognitive defusion practices, mindfulness exercises for present‑moment awareness, values clarification, values‑based goal setting, and committed action planning with homework assignments. Educational materials include presentation slides, a homework booklet, and simple practice files. The sessions are delivered by a clinical psychologist trained in ACT. To ensure treatment fidelity, sessions are reviewed by a senior researcher or clinical supervisor using a fidelity checklist, and participants’ homework assignments are documented and evaluated.
Category
Behavior
2
Description
Control group: The control group receives routine care and does not receive any additional psychological intervention. Routine care includes standard medical follow‑up, general dermatological advice, and prescribed medications provided by the dermatologist. To maintain structural equivalence, the control group receives only minimal contact during the study period (limited to necessary follow‑up calls for scheduling assessments), and no educational or therapeutic sessions are provided. After data collection is completed, participants in the control group are offered a brief educational package on stress management and self‑care if they wish.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahta Abdoli
Street address
Imam Reza Hospital, Emam Reza Street
City
Amol
Province
Mazandaran
Postal code
4614937597
Phone
+98 11 4327 2011
Email
name@imamreza.mazums.az.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmaeil Fattahi
Street address
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
City
Amol
Province
Mazandaran
Postal code
4661616917
Phone
+98 11 4321 7000
Email
name@amol.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Babol University of Medical Sciences
Full name of responsible person
Alireza Azizi
Position
University Faculty Members
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
City
Amol
Province
Mazandaran
Postal code
4713655365
Phone
+98 11 3222 3594
Email
name@azizi.a.re
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahta Abdoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
City
Amol
Province
Mazandaran
Postal code
4613856348
Phone
+98 11 4324 5937
Email
name@mhta.abdoli98
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahta Abdoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
City
Amol
Province
Mazandaran
Postal code
4613856348
Phone
+98 11 4324 5937
Email
name@mhta.abdoli98
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this 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
No - There is not 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available