Comparison of the effectiveness of therapeutic schema and dialectical behavior therapy on cognitive regulation of emotion, cognitive flexibility and maladaptive strategies of worry in patients with depressive disorder.
Compare the effectiveness of schema therapeutic and dialectical behavior therapy on cognitive regulation of emotion, cognitive flexibility, and maladaptive worry strategies in patients with depressive disorder.
Design
Clinical trial with control group with parallel groups consisting of 45 patients with moderate depressive disorder selected by clinical interview based on DSM-V.The presence and severity of depression symptoms were assessed by the Beck depression questionnaire.The study was a blind, randomized study using a table of random numbers (15 people in each group).
Settings and conduct
The research was conducted in the Hami counseling center. Group training sessions were determined and the participants were privately informed to attend the sessions
Participants/Inclusion and exclusion criteria
Inclusion Criteria: receiving a diagnosis of moderate depression, not taking medication
Exclusion criteria: Receiving a diagnosis of mild or severe depression, receiving a diagnosis of moderate depression, taking medication at the same time, and having mood problems caused by taking medication.
Intervention groups
1-Dialectical behavior therapy : The protocol of this treatment is implemented in four weeks in a group for 8 sessions of 90 minutes.
2- Schema therapy : The protocol of this therapy is implemented in the experimental group during 8 sessions in the form of 90-minute weekly sessions.
3- Control : This group will not receive treatment during the research, but they will be treated at the end of the research.
Main outcome variables
The main result of the effectiveness of therapeutic schema and dialectical behavior therapy is to reduce the symptoms of depression and cognitive regulation of excitement, cognitive flexibility and maladaptive strategies of worry.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230517058212N1
Registration date:2023-08-06, 1402/05/15
Registration timing:retrospective
Last update:2023-08-06, 1402/05/15
Update count:0
Registration date
2023-08-06, 1402/05/15
Registrant information
Name
Zohre Jafarzade jahromi
Name of organization / entity
Islamic Azad University, Birjand branch
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 1137
Email address
zjafarzade.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-01, 1401/08/10
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
2022-10-24, 1401/08/02
Actual recruitment end date
2022-12-21, 1401/09/30
Trial completion date
2023-01-24, 1401/11/04
Scientific title
Comparison of the effectiveness of therapeutic schema and dialectical behavior therapy on cognitive regulation of emotion, cognitive flexibility and maladaptive strategies of worry in patients with depressive disorder.
Public title
Comparing the efficacy of schema therapy and dialectical behavior therapy in patients with depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receive a diagnosis of moderate depression
Not taking medicine
Non-participation in any type of therapeutic intervention at the same time as participation in the research program
Expression of desire to participate in the program in writing
Exclusion criteria:
Receive a diagnosis of personality disorders
The presence of mood problems caused by drug use or biological problems
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, 45 people who were selected as samples were numbered from 1 to 45.And these numbers were placed randomly without any particular order in the form of rows and columns in the table.Then one row and one column of the table were randomly selected. The intersection point of the selected row and column was the starting point of sampling.From this point and at the choice of the researcher, a direction (up, down, left or right) was drawn to select the members of the experimental and control groups.The numbers 15-00 obtained from the direction of the researcher's movement were selected as the first test group, and the numbers 16-30 as the second test group, and the numbers 45-31 as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants generally knew that they were undergoing psychotherapy.But they did not know that they were undergoing dialectical behavior therapy or schema therapy.Also, the data analyst did not know what treatment each participant was under or in which group they were (but the researcher did).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
21 Ostad Motahari St
City
Jahrom
Province
Fars
Postal code
74157-13548
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.BUMS.REC.1401.265
Health conditions studied
1
Description of health condition studied
Patients with depressive disorder
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Treatment of depressive disorder
Timepoint
Before the study, in the middle of the study (two weeks after the start of the treatment) and after finishing the treatmenttraining sessions
Method of measurement
Beck depression questionnaire
Secondary outcomes
1
Description
Cognitive regulation of emotion
Timepoint
After therapeutic interventions
Method of measurement
Using the cognitive emotion regulation strategies questionnaire of Garnevsky et al. (2002)
2
Description
Cognitive flexibility
Timepoint
After therapeutic interventions
Method of measurement
Using the Cognitive Flexibility Questionnaire of Dennis and Vanderwaal (2010)
3
Description
Maladaptive worry strategies
Timepoint
After therapeutic interventions
Method of measurement
Using the questionnaire of incompatible strategies, Meiryar et al. (1990)
Intervention groups
1
Description
Schema therapy: Schema therapy instructions and techniques were implemented on the experimental group during 8 sessions in the form of weekly 90-minute sessions.The first and second session: these sessions were dedicated to the implementation of the assessment phase and preliminary training of schema therapy.The third and fourth session: introduction, training and application of cognitive techniques was the challenge with the schema.Fifth and sixth sessions: Emotional (experimental) techniques were introduced and taught.7th and 8th sessions: training and implementation of behavioral pattern breaking techniques, persuading subjects to abandon incompatible coping styles and practice effective coping behaviors.
Category
Treatment - Other
2
Description
Dialectical behavior therapy: The dialectical behavior therapy training protocol was implemented in four weeks as a group for 8 sessions of 90 minutes.In the first session: after getting acquainted with the goals and rules, the group members were introduced to three mental states, logical, emotional and rational, in the comprehensive awareness skills section.The second session: in this session, in addition to the training of the mental states of the previous session, the training of the skills of what and how skills of comprehensive awareness were taught.The third session: what and how skills were practically taught in the group.Fourth session: In this stage, in addition to reviewing the exercises of the previous session, part of the emotional regulation skill was taught.Fifth session: Another part of emotional regulation skills was taught in this session.Sixth session: In this session, while reviewing the skills of the previous session, the skills of accepting emotions were taught.Seventh session: In this session, a part of the stress tolerance component was taught.In the eighth session, the review of the previous skills was considered as well as teaching how to generalize the skills outside the treatment session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hami Psychology and Counseling Center
Full name of responsible person
Zohre Jafarzade
Street address
22 Bahman Street, Hakim Medical Complex
City
Jahrom
Province
Fars
Postal code
74157-13548
Phone
+98 71 5422 2573
Email
Zjafarzade.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Birjand branch
Full name of responsible person
Dr. Seyyed Abdolmajid Bahrainian
Street address
Ostad Motahari St., Alley 21
City
Jahrom
Province
Fars
Postal code
74157-13548
Phone
+98 912 778 6737
Email
Majid.bahrainian@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, Birjand 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, Birjand branch
Full name of responsible person
Zohre Jafarzade
Position
PhD Student in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ostad Motahari St., Alley 21
City
Jahrom
Province
Fars
Postal code
74157-13548
Phone
+98 71 5433 1137
Email
Zjafarzade.j@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Birjand branch
Full name of responsible person
zohre Jafarzade Jahromi
Position
PhD Student in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
21 Ostad Motahari St
City
Jahrom
Province
Fars
Postal code
74157-13548
Phone
+98 71 5433 1137
Email
Zjafarzade.j@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Birjand branch
Full name of responsible person
Zohre Jafarzade
Position
PhD Student in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ostad Motahari St., Alley 21
City
Jahrom
Province
Fars
Postal code
74157-13548
Phone
+98 71 5433 1137
Email
Zjafarzade.j@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
Parts of the data, such as information about the intervention and its effect on dependent variables, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request for researchers engaged in research in the field of mental illnesses
From where data/document is obtainable
1- The e-mail address of Zohre Jafarzade Jahormi is zjafarzade.j@gmail.com
2- Zohre Jafarzade's contact number: 09308352827
What processes are involved for a request to access data/document
First, the researcher introduces herself by sending her an email and explaining the reason for the need for data, and in less than a month, she will be answered and the data will be sent.