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The Effectiveness of Transdiagnostic Cognitive-Behavioral Therapy Protocol on Reducing Subclinical Symptoms of Anxiety and Depression, Improving Emotion Regulation, Resilience and Spiritual Health in Students

Protocol summary

Study aim
Determining the effectiveness of transdiagnostic cognitive-behavioral therapy protocol on reducing preclinical symptoms of anxiety and depression, improving emotion regulation, resilience and spiritual health in students
Design
A randomized, randomized controlled clinical trial on 56 patients.
Settings and conduct
In this research, after receiving the code of ethics from the ethics committee of Shahid Beheshti University of Medical Sciences, sample people are selected based on the Inclusion criteria, and then after the initial interview according to SCID-5-RV and declaring their willingness to participate in the meetings, explanations They are given about research. All participants complete the DASS, CERQ, CD-RISC, SWB, and CFI questionnaires before starting the treatment during the introductory session and then immediately after the course and 2 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having preclinical anxiety and depression symptoms based on the cut-off point of a score of 18 and above in the DASS-42 subscale and a score of 16 and above in the anxiety subscale of the DASS-42 scale, Not suffering from severe psychiatric disorders, Not using drugs and alcohol in the last three months. Willingness to participate in research. Exclusion criteria: receiving cognitive-behavioral interventions for at least 8 sessions in the last 1 year.
Intervention groups
Intervention group: includes all students of Farhangian University of Tehran province who receive integrated transdiagnostic treatment as a group in 14 sessions of 60 minutes on a weekly basis. The control group includes students who do not receive any intervention.
Main outcome variables
Connor and Davidson Resilience Scale (CD-RISC), Cognitive Emotion Regulation Questionnaire (CERQ), Depression- Anxiety- Stress Scale (DASS), Cognitive flexibility scale (CFI), Spiritual well-being questionnaire (SWB)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211223053494N4
Registration date: 2023-05-11, 1402/02/21
Registration timing: prospective

Last update: 2023-05-11, 1402/02/21
Update count: 0
Registration date
2023-05-11, 1402/02/21
Registrant information
Name
Jafar Sarani yaztappeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 1334 1894
Email address
sarani.jafar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Transdiagnostic Cognitive-Behavioral Therapy Protocol on Reducing Subclinical Symptoms of Anxiety and Depression, Improving Emotion Regulation, Resilience and Spiritual Health in Students
Public title
The Effectiveness of Transdiagnostic Cognitive-Behavioral Therapy Protocol on Subclinical Symptoms of Anxiety and Depression, Emotion Regulation, Resilience and Spiritual Health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having preclinical anxiety and depression symptoms based on the cut-off point of a score of 18 and above in the DASS-42 subscale and a score of 16 and above in the anxiety subscale of the DASS-42 scale, Not suffering from specific or underlying physical diseases, Not suffering from severe psychiatric disorders such as bipolar spectrum disorders, psychotic spectrum disorders, and cognitive disorders. Not using drugs and alcohol in the last three months. Absence of speech or hearing problems Willingness to participate in research
Exclusion criteria:
absence of more than two sessions, receiving another similar psychological intervention at the same time as the current research, receiving cognitive-behavioral interventions for at least 8 sessions in the last 1 year, receiving psychiatric drugs at the same time as the intervention or within a month before the intervention, Lack of consent to continue the treatment during the intervention process, Aggravation of the person's problems during the intervention and the need to provide another intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization. The randomization unit is people. 56 student subjects will be divided into intervention and control groups by Microsoft Excel software using Rand function. Based on this, a table of random numbers is prepared and the Randbetween function is created, and the subjects are placed in two groups of 28 people according to the rows of this table.
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
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Shahid Beheshti University of Medical Sciences, Shahid Chamran Evin Highwa
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.407

Health conditions studied

1

Description of health condition studied
Anxiety, Depression, Emotion Regulation, Resilience and Spiritual Health
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
Cognitive Emotion Regulation Score (CERQ) in the Garnevsky Questionnaire, Craig Vaspinhaven
Timepoint
At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)

2

Description
Depression, anxiety and stress score in Lovibond and Lovibond scale
Timepoint
At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS)

Secondary outcomes

1

Description
Spiritual well-being score in Paloutzian and Ellison questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention
Method of measurement
Spiritual well-being (SWB)

2

Description
Cognitive flexibility score in Dennis scale
Timepoint
At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention
Method of measurement
Cognitive flexibility scale (CFI)

3

Description
Connor and Davidson Resilience Scale (CD-RISC)
Timepoint
At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention
Method of measurement
Connor and Davidson Resilience Scale (CD-RISC)

Intervention groups

1

Description
Intervention group: includes all students of Farhangian University of Tehran province who receive integrated transdiagnostic treatment as a group according to the protocol in 14 sessions of 60 minutes on a weekly basis. This treatment was designed by Barlow et al (2011). The content of the first session: (module one): improving motivation to engage in treatment, introducing motivation and discussing its importance for the outcome of treatment, helping the patient to evaluate the pros and cons of changing, helping the patient to evaluate the pros and cons of not changing, helping the patient to establish specific treatment goals, helping the patient to determine manageable steps to achieve the treatment goals. The second session (second module): psychological education and the logic of therapy, reviewing the assignment of the previous session, creating an overview of the functional and adaptive nature of emotions, presenting the three components of emotional experiences (thoughts, physical feelings and behaviors), introducing the concept of behaviors arising from emotions, Introducing the antecedents, responses and consequences of emotional experiences, discussing the learned responses of the third and fourth session (third module): emotional awareness training, reviewing the assignment of the previous session, introducing non-judgmental emotional awareness, introducing present-focused awareness, implementing emotional awareness exercises within the session, help To the patient to practice techniques using mood induction using music in the fifth and sixth session (fourth module): Cognitive Appraisal and Reappraisal, review of the assignment of the previous session, explanation of the mutual relationship between thoughts and emotions, introduction of automatic evaluations, introduction of mental traps common and helping the patient to identify them, introducing cognitive re-evaluation and helping the patient to practice it in order to increase flexibility in thinking, the seventh session (fifth module): emotional avoidance and behaviors arising from emotion, review of the assignment of the previous session, introducing the concept of emotional avoidance, Introducing the types of emotional avoidance strategies and discussing the contribution of these strategies in the negative cycle of emotional response, helping the patient to identify his emotional avoidance strategies, proving the contradictory effects of emotional avoidance, re-introducing the concept of behaviors arising from emotion and discussing them more deeply, introducing the logic of confrontation with behaviors arising from emotions, identifying behaviors arising from maladaptive emotions, the eighth session (sixth module): Awareness and Tolerance of Physical Sensations, reviewing the previous session's assignment, helping the patient to identify internal physical feelings related to emotions, helping the patient to gain more understanding From the role of internal physical feelings in creating an emotional response, performing symptomatic exercises designed to evoke uncomfortable physical feelings, sessions 9 to 13 (seventh module): Interoceptive and Situational Emotion Exposures, reviewing the assignment of the previous session, helping the patient to understand the purpose of emotional exposures. , helping the patient to create a hierarchy of emotional and situational avoidance, designing effective emotion coping exercises, helping patients to face strong emotions through emotional coping exercises, the fourteenth session (eighth module): Accomplishments, Maintenance, and Relapse Prevention, Reviewing the assignment of the previous session, reviewing coping skills, reviewing treatment progress, identifying and fixing potential or common triggers, promoting the generalization of skills, and establishing goals for continuous improvement.
Category
Treatment - Other

2

Description
Control group: includes students who do not receive intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Jafar Sarani Yaztappeh
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Email
sarani.jafar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsin Zarghi
Street address
Vice-Chancellor of Research Affairs,Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Erabi Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Elnaz Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
1452687818
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Elnaz Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
1452368712
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Sarani Yaztappeh
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Email
sarani.jafar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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