The impact of expressive writing versus acceptance and commitment therapy on inflammatory biomarkers, cognitive functioning, and psychological well-being in high-school students with moderate-to-severe stress or anxiety
The comparative efficacy of expressive writing and acceptance and commitment therapy in the reduction of stress biomarkers and the improvement of psychological and cognitive health in adolescents
Design
A clinical trial designed with two parallel intervention groups, and randomized on 48 samples. The randomization method was conducted using the random block method with four blocks and the online tool Sealed Envelope
Settings and conduct
The study will include students attending a specified school (Sarv-e-Danesh, located in Shahriar, Tehran) who exhibit moderate to high stress or anxiety levels, as indicated by the DASS-42. The participants are randomly assigned to either the EW or ACT intervention group using the block randomization method. The experimental group will utilize expressive writing as a means of managing anxiety and stress over the course of six weeks, while the control group will engage in acceptance and commitment therapy during the same period. Prior to and following the conclusion of the treatment period, the blood levels of NLR, CRP, and cortisol will be quantified, and the scores from the DASS-42 and the PASAT will be ascertained. Subsequently, the changes observed in the two groups will be compared.
Participants/Inclusion and exclusion criteria
Students aged 15 to 20 who exhibit a DASS-42 stress score exceeding 18 or an anxiety score exceeding 9
Intervention groups
The experimental group will utilize expressive writing as a means of managing anxiety and stress over the course of six weeks, while the control group will engage in acceptance and commitment therapy during the same period
Main outcome variables
Stress biomarkers in the blood, including cortisol, C-reactive protein (CRP), and the neutrophil-to-lymphocyte ratio (NLR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240910063001N2
Registration date:2024-10-05, 1403/07/14
Registration timing:prospective
Last update:2024-10-05, 1403/07/14
Update count:0
Registration date
2024-10-05, 1403/07/14
Registrant information
Name
Hasan Moltazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 4148
Email address
h-moltazemi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of expressive writing versus acceptance and commitment therapy on inflammatory biomarkers, cognitive functioning, and psychological well-being in high-school students with moderate-to-severe stress or anxiety
Public title
Expressive writing and acceptance and commitment therapy for stress and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be between the ages of 15 and 20
A stress score of more than 18 or an anxiety score of more than 9 in the psychological interview based on the Depression, Anxiety and Stress Scale-42
Informed consent of the patient and legal guardian for participation
Exclusion criteria:
History of significant psychiatric, neurological, or endocrine disorders
Prior engagement in psychotherapy
Current pharmacological treatment with psychotropic medications or steroids
Lack of compliance, defined as failure to participate in more than two follow-up sessions
Age
From 15 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into two groups, ACT and EW, using the random block method. Block randomization will be conducted using the website https://www.sealedenvelope.com. Each block will consist of four members, and the resulting combination will be as follows: [ABAB], [ABBA], [AABB], [BBAA], [BABA], [BAAB], where code "A" corresponds to the EW group and code "B" corresponds to the ACT group. The aforementioned website randomly selects 12 quadruple blocks, thus including 48 patients in the study. To ensure the allocation is concealed, a code is devised for each participant based on the generated blocks. These codes will be provided to the researcher at the time of admission by the study coordinator.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2024-09-16, 1403/06/26
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.117
Health conditions studied
1
Description of health condition studied
Stress, not elsewhere classified
ICD-10 code
Z73.3
ICD-10 code description
Physical and mental strain NOS
2
Description of health condition studied
Anxiety disorder, unspecified
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS
Primary outcomes
1
Description
Serum cortisol
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Laboratory test
2
Description
Serum C-reactive protein
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Laboratory test
3
Description
Neutrophil-to-lymphocyte ratio
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Laboratory test
Secondary outcomes
1
Description
Working memory and processing speed
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Paced Auditory Serial Addition Test
2
Description
Stress
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Depression, Anxiety, Stress Scale-42
3
Description
Anxiety
Timepoint
Before the start of the intervention and one week after its end (week 7)
Method of measurement
Depression, Anxiety, Stress Scale-42
Intervention groups
1
Description
Intervention group (EW): a course of expressive writing therapy, comprising three consecutive days of therapy per week, with each session lasting 15 minutes, over a period of six weeks. The therapy was conducted under the guidance of a psychology expert, with follow-up sessions conducted via telephone
Category
Behavior
2
Description
Control group (ACT): a course of acceptance and commitment therapy in the form of six one-hour group sessions over six weeks based on the headings of the educational protocol of acceptance and commitment therapy
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hedayat Sahraei
Street address
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4148
Email
h.sahraei@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fooladi
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Shahyad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 4148
Email
shima.shahyad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Shahyad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 4148
Email
shima.shahyad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Shahyad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 4148
Email
shima.shahyad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after participants are de-identified
When the data will become available and for how long
Six months after the results have been published
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
Systematic review studies and meta-analysis
From where data/document is obtainable
Shima Shahyad
What processes are involved for a request to access data/document