Protocol summary

Study aim
Determining the effectiveness of schema therapy on self-compassion and cognitive distortion of adolescents affected by emotional failure
Design
This clinical trial study is a control group, parallel group, double-blind, and randomized (sealed envelope) study. It is conducted on 30 male adolescents with a history of emotional breakdown within the past 3 months and referred to the Toloo Psychology Clinic. It includes a control group (15 people) and an intervention group that participates in therapy sessions, and the results of the groups' questionnaires are evaluated before and after the intervention.
Settings and conduct
30 clients of the Toloo Psychology Clinic who did not have diagnosed disorders such as depression or anxiety were randomly assigned to two experimental and control groups (15 people each). Both groups first completed self-compassion and cognitive distortion questionnaires as a pre-test. The experimental group then participated in 10 sessions of Young's (2003) schema therapy and then completed the same questionnaires as a post-test; the control group did not receive any intervention. The study was conducted in a double-blind manner, and each participant was assigned a code.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 15-18 years; Male adolescents with emotional trauma in the last 3 months; Adolescents who score high on the Ross Love Trauma Questionnaire (1999). Exclusion criteria: Adolescents with disorders such as depression and anxiety.
Intervention groups
Control group: 15 adolescents with inclusion criteria who do not receive any intervention in this group. Intervention group: 15 adolescents with inclusion criteria who participate in 10 90-minute sessions of schema therapy based on Young's (2003) theory. They are assessed with pre-test and post-test questionnaires.
Main outcome variables
Self-Compassion; Cognitive Distortion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250709066430N1
Registration date: 2025-08-05, 1404/05/14
Registration timing: prospective

Last update: 2025-08-05, 1404/05/14
Update count: 0
Registration date
2025-08-05, 1404/05/14
Registrant information
Name
Mohammad Nabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 4422 5584
Email address
mohammad.nabaei@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-03, 1404/06/12
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of schema therapy on self-compassion and cognitive distortion of adolescents affected by emotional failure
Public title
The effectiveness of schema therapy on self-compassion and cognitive distortion of adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Male teenagers who have been injured due to emotional failure during the last 3 months. Age range between 15-18 years Adolescents who score high on the Ross Love Impact Questionnaire (1999)
Exclusion criteria:
Adolescents with disorders such as depression and anxiety
Age
From 15 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Experimental and control groups: After selecting the sample, the next step involves dividing people into experimental and control groups using a random method. How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from 1 to 30 are assigned to people). Second step: From these people, using a random method using sealed and opaque (numbered) envelopes, people are divided into two experimental groups and a control group. Each person randomly selects an envelope and is divided into the corresponding group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was conducted in a double-blind manner; participants, caregivers, and evaluators were unaware of group assignment, and a unique code was assigned to each individual.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University -Varamin- Pishva Branchn
Street address
Islamic Azad University, Varamin–Pishva Branch, Naghsh-e Jahan Town, Pishva County, Tehran, Iran
City
Varamin
Province
Tehran
Postal code
7489533817
Approval date
2025-06-10, 1404/03/20
Ethics committee reference number
IR.IAU.VARAMIN.REC.1404.038

Health conditions studied

1

Description of health condition studied
Emotional failure
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified

Primary outcomes

1

Description
Self -Compassion
Timepoint
It will be assessed before and after the intervention.
Method of measurement
Self-Compassion Questionnaire (Neff, 2003)

2

Description
Cognitive Distortion
Timepoint
Before the intervention and after the intervention
Method of measurement
Abdollahzadeh and Salar Cognitive Distortion Questionnaire 2010

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 15 participants who meet the inclusion criteria and do not have disorders such as depression or anxiety diagnosed by a therapist will be randomly assigned to the study as the control group. They will complete the self-compassion and cognitive distortion questionnaire, but no treatment will be given to this group.
Category
Behavior

2

Description
Intervention group: 15 participants in the study who meet the inclusion criteria and do not have disorders such as depression and anxiety diagnosed by the therapist will be randomly assigned to the intervention group. They will complete the self-compassion and cognitive distortion questionnaire as a pre-test, then undergo 10 sessions of schema therapy based on Yang (2003), each session lasting 90 minutes, and after completing the sessions, they will complete the self-compassion and cognitive distortion questionnaires as a post-test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Toloo Specialized Center for Psychology, Psychiatry
Full name of responsible person
sareh falatoni
Street address
Unit 2, First Floor, No. 39, Ziba St., Shariati St., Above Mirdamad Blvd., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1948833413
Phone
+98 21 2289 3592
Email
Toloo.psychocilnic1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad University, South Tehran Branch
Full name of responsible person
Razieh Farazkish
Street address
7th Floor, Islamic Azad University, South Tehran Branch Building, Corner of Azarshahr St. and Iranshahr St., Karimkhan Zand St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1584715414
Phone
+98 21 3378 3737
Email
research@azad.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University, South Tehran Branch
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
Mohammad Nabaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 5, No. 155, Yas 7 Alley, Pasgah Street, Hashtgerd, Alborz, Iran
City
Hashtgerd
Province
Alborz
Postal code
۳۳۶۱۶۷۳۷۷۸
Phone
+98 26 4423 2684
Email
mohamad78.nabie19@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hosein Tavakoli
Position
Assistant Professor, South Tehran Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Valiasr Complex, South Tehran Branch, Islamic Azad University, Damavand Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1734643905
Phone
+98 21 7746 2251
Email
Rinotavakoli55@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Nabaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 5, No. 155, Yas 7 Alley, Pasgah Street, Hashtgerd, Alborz, Iran
City
Hashtgerd
Province
Alborz
Postal code
۳۳۶۱۶۷۳۷۷۸
Phone
+98 26 4423 2684
Email
mohamad78.nabie19@gmail.co

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
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 4 months after the results are published and after personally identifiable information is removed.
To whom data/document is available
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.
Under which criteria data/document could be used
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.
From where data/document is obtainable
If you need data, please contactmohamad78.nabie19@gmail.com
What processes are involved for a request to access data/document
After receiving and reviewing the request from the researcher, a response will be provided as soon as possible.
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