The Effectiveness of Cognitive Behavioral Therapy (CBT) on Post‑Traumatic Stress, Mental Health, and Depression in Neglected and Orphaned Adolescents Living in Residential Care Centers in Shiraz
The Effectiveness of Cognitive Behavioral Therapy (CBT) on Post‑Traumatic Stress, Mental Health, and Depression in Neglected and Orphaned Adolescents
Design
A controlled clinical trial with parallel, unblinded, randomized groups on 30 individuals. The rand function of Excel software was used for randomization.
Settings and conduct
The method of the present study was a quasi-experimental study with a pre-test-post-test design with a control group. The statistical population of this study included all neglected and unsupervised adolescents living in care centers in Shiraz in 1405. This population included five official care centers for adolescents, with a total of 32 eligible individuals between the ages of 12 and 18
Participants/Inclusion and exclusion criteria
Meeting diagnostic criteria for depressive disorders; age 12 to 18 years; parental consent; individual availability
Intervention groups
In the present study, the cognitive-behavioral treatment protocol for depression was used. This treatment protocol is designed based on the cognitive-behavioral approach and is presented in the form of a structured program consisting of 12 treatment sessions. The initial framework of this program was presented by Munoz and Miranda in the book "Cognitive-Behavioral Treatment of Depression" and was developed in research projects at the University of California, San Francisco and the Prevention Centers affiliated with Palo Alto University.
The control group received no intervention and was placed on a waiting list for treatment.
Main outcome variables
Post‑traumatic stress disorder score; Mental health score; Depression score
General information
Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number:IRCT20260509069302N1
Registration date:2026-05-19, 1405/02/29
Registration timing:prospective
Last update:2026-05-19, 1405/02/29
Update count:0
Registration date
2026-05-19, 1405/02/29
Registrant information
Name
Seyede Tarah Hosseini Haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 312 7361
Email address
tarah.hosseini.h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-20, 1405/02/30
Expected recruitment end date
2026-06-20, 1405/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Cognitive Behavioral Therapy (CBT) on Post‑Traumatic Stress, Mental Health, and Depression in Neglected and Orphaned Adolescents Living in Residential Care Centers in Shiraz
Public title
Cognitive Behavioral Therapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria for depressive disorders
Age 12 to 18 years
Parental consent
Availability of the individual
Exclusion criteria:
Presence of severe psychiatric disorders such as psychotic disorders or bipolar disorder based on medical records or clinical assessment
Cognitive or intellectual impairment that interferes with understanding or participation in cognitive behavioral therapy sessions
Concurrent participation in structured psychological therapy similar to the intervention at the time of enrollment
Changes in psychiatric medication within the past four weeks
Presence of severe or unstable medical illness that prevents participation in therapy sessions
Lack of informed consent from the legal guardian or the adolescent participant
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be enrolled after providing informed consent. Participants will then be randomly assigned to either the intervention group (cognitive behavioral therapy) or the control group using simple randomization based on a computer-generated random numbers table. The allocation ratio will be 1:1.
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 Firozabad Azad University
Street address
No 34, Fadak Blvd
City
shiraz
Province
Fars
Postal code
7156787498
Approval date
2024-05-30, 1403/03/10
Ethics committee reference number
IR.IAU.M.REC.1403.520
Health conditions studied
1
Description of health condition studied
Depression, post-traumatic stress
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
Post‑traumatic stress disorder score measured by a PTSD scale at baseline and after completion of the intervention
Timepoint
Before treatment, after the end of treatment
Method of measurement
Mississippi Questionnaire
2
Description
Score of mental health measured by the General Health Questionnaire (GHQ‑28) at baseline and after completion of the intervention
Timepoint
Before treatment, after the end of treatment
Method of measurement
General Health Questionnaire (GHQ-28)
3
Description
Severity of depressive Depression score measured by a depression questionnaire at baseline and after completion of the intervention
Timepoint
Before treatment, after the end of treatment
Method of measurement
Beck depression questionnaire
Secondary outcomes
1
Description
Post‑traumatic stress disorder score measured by a PTSD scale at baseline and after completion of the intervention
Timepoint
After the intervention
Method of measurement
Mississippi Questionnaire
2
Description
Score of mental health measured by the General Health Questionnaire (GHQ‑28) at baseline and after completion of the intervention
Timepoint
After the intervention
Method of measurement
General Health Questionnaire (GHQ-28)
3
Description
Depression score measured by a depression questionnaire at baseline and after completion of the intervention
Timepoint
After the intervention
Method of measurement
Beck depression questionnaire
Intervention groups
1
Description
Intervention group: Participants in this group will receive group‑based Cognitive Behavioral Therapy (CBT). The intervention consists of eight weekly sessions lasting 60 minutes each, delivered by a trained therapist. The sessions include cognitive restructuring, identification and modification of dysfunctional thoughts, coping skills training, and emotion regulation techniques.
Category
Behavior
2
Description
Control group: Participants in this group will receive routine services provided by the residential center and will not receive the CBT intervention during the study period. After completion of the study, the intervention will be offered if desired.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz city care centers
Full name of responsible person
Seyedeh Tara Hoseinihaghighi
Street address
Fadak st.
City
Shiraz
Province
Fars
Postal code
7156787498
Phone
+98 71 3725 8261
Email
tarah.hosseini.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behboudi Green Villa Maintenance Center
Full name of responsible person
Hadi Daneshparvar
Street address
Vilay sabz, kavar Street, Modares Blvd
City
shiraz
Province
Fars
Postal code
7166694696
Phone
+98 71 3272 5447
Email
5480112082@iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behboudi Green Villa Maintenance Center
Proportion provided by this source
50
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
Persons
2
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadi Daneshparvar
Street address
Vilay sabz center, kavarstreet, Modars Blvd
City
shiraz
Province
Fars
Postal code
7166694696
Phone
+98 71 3273 5447
Email
ramin3677s@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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede Tarah
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fadak st.
City
Shiraz
Province
Fars
Postal code
7156787498
Phone
+98 71 3725 8261
Email
tarah.hosseini.h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede Tarah
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fadak st.
City
Shiraz
Province
Fars
Postal code
7156787498
Phone
+98 71 3725 8261
Email
tarah.hosseini.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede Tarah
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fadak st.
City
Shiraz
Province
Fars
Postal code
7156787498
Phone
+98 71 3725 8261
Email
tarah.hosseini.h@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data, such as information related to the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts from March 2027
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
General data is for guidance only.
From where data/document is obtainable
I am Seyyed Tara Hosseini Haghighi - Rost Psychological Counseling and Services Center - Shiraz, North Motahari Boulevard - Ibn Sina Medical Building - Second Floor, Unit 8 - 09173127361
What processes are involved for a request to access data/document
The applicant must send his/her application with a complete explanation of why and how the work is being done to my email address tarah.hosseini.h@gmail.com