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The effectiveness of acceptance and commitment therapy on perceived stress, depressive symptoms, and psychosomatic problems in women with depression referring to counseling services

Protocol summary

Study aim
Determining the effectiveness of acceptance and commitment therapy on perceived stress, depressive symptoms, and psychosomatic problems in women with depression referring to counseling services in Ahvaz
Design
A controlled, double-blind, randomized, phase 2 clinical trial with parallel groups on 30 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Acceptance and commitment therapy will be investigated on perceived stress, depressive symptoms, and psychosomatic problems in women with depression referring to counseling services in Ahvaz. The present study will be conducted using a quasi-experimental design on two comparison groups in three stages: pre-test, post-test, and one-month follow-up. The research sample is purposive.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study are:) Having at least a high school diploma A score higher than 19 on the Depression and Perceived Stress Test Exclusion criteria also include: Having psychotic symptoms of hallucinations and delusions Presence of personality disorders
Intervention groups
Experimental group (ACT intervention): This group receives acceptance and commitment therapy. ACT therapy focuses on accepting unpleasant thoughts and feelings (without trying to change them) and adhering to personal values to create meaningful behavioral changes. Sessions of this therapy usually include exercises in mindfulness, acceptance, cognitive defusion, connecting with values, and committed action. Control group: This group does not receive any specific intervention: This group does not receive any specific intervention and simply acts as a control group so that changes in the experimental group can be compared with their baseline status.
Main outcome variables
Perceived stress, depressive symptoms, and psychosomatic problems

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250603066055N1
Registration date: 2025-07-19, 1404/04/28
Registration timing: registered_while_recruiting

Last update: 2025-07-19, 1404/04/28
Update count: 0
Registration date
2025-07-19, 1404/04/28
Registrant information
Name
Alireza Mohammadi khorasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5273 1452
Email address
alirezamohammadikhorasani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-10, 1404/04/19
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on perceived stress, depressive symptoms, and psychosomatic problems in women with depression referring to counseling services
Public title
The effectiveness of acceptance and commitment therapy on perceived stress, depressive symptoms, and psychosomatic problems in women with depression referring to counseling services
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a high school diploma A score higher than 19 on the Depression and Perceived Stress Test Not having undergone psychotherapy in the past six months due to the possibility of confounding the results of the present study
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
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 Islamic Azad University of Ahvaz
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr ، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6184793154
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.102

Health conditions studied

1

Description of health condition studied
Acceptance and commitment therapy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Perceived stress
Timepoint
2
Method of measurement
Cohen's Perceived Stress Questionnaire, Psychosomatic Symptoms Questionnaire

2

Description
Symptoms of depression
Timepoint
2
Method of measurement
Depression Questionnaire

3

Description
Psychosomatic problems
Timepoint
2
Method of measurement
Psychosomatic symptom questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acceptance and commitment therapy is applied.
Category
Treatment - Other

2

Description
Control group: did not receive acceptance and commitment therapy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Farzmand Klantari
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 3334 8421
Email
farashenakht.32@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 3334 8421
Email
farashenakht.32@gmail.com
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
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
Islamic Azad University
Full name of responsible person
Alireza Mohammadi khorasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 22 Zip، Tohid Alley ،Pardis Park
City
Behbehan
Province
Khouzestan
Postal code
6361683719
Phone
+98 61 5273 1452
Fax
Email
alirezamohammadikhorasani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Mohammadi khorasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 22 Zip، Tohid Alley ،Pardis Park
City
Behbehan
Province
Khouzestan
Postal code
6361683719
Phone
+98 61 5273 1452
Fax
Email
alirezamohammadikhorasani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Mohammadi khorasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 22 Zip، Tohid Alley، Pardis Park
City
Behbehan
Province
Khouzestan
Postal code
6361683719
Phone
+98 61 5273 1452
Fax
Email
alirezamohammadikhorasani@gmail.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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