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The effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder

Protocol summary

Study aim
Determining the effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder.
Design
A randomized, controlled, and parallel-group clinical trial on 30 individuals with bipolar disorder used a simple randomization method to randomize participants.
Settings and conduct
The study, conducted at the Empathy Psychology Clinic in Semnan, involves people with bipolar disorder. Participants are randomly assigned to two groups: an experimental group that receives cognitive-behavioral therapy (CBT) and a control group that receives only usual care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of bipolar disorder by a specialist, age between 20 and 50, ability to attend meetings and complete questionnaires, fluency in Persian, and verbal communication. Exclusion criteria: Severe psychiatric disorders (such as schizophrenia or severe personality disorders), severe drug or alcohol dependence, history of suicide attempt in the past six months, and debilitating physical illness that prevents attendance at meetings.
Intervention groups
In this study, the experimental group will participate in 8 90-minute sessions over a period of one month, which are designed based on cognitive-behavioral therapy (CBT). The content of these sessions includes identifying and modifying dysfunctional thoughts, teaching emotion regulation strategies, and strengthening psychological capital. The control group will receive only usual care and no specific therapeutic intervention will be provided to them.
Main outcome variables
Quality of life, psychological capital

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250223064825N1
Registration date: 2025-03-29, 1404/01/09
Registration timing: prospective

Last update: 2025-03-29, 1404/01/09
Update count: 0
Registration date
2025-03-29, 1404/01/09
Registrant information
Name
Kiana Emadi
Name of organization / entity
Islamic Azad University, Semnan Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3337 3652
Email address
kiana.emadii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-12, 1404/01/23
Expected recruitment end date
2025-05-13, 1404/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder
Public title
The effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of bipolar disorder by a psychiatrist or clinical psychologist. Age range between 20 and 50 years. Ability to participate in therapy sessions, complete questionnaires, and benefit from psychotherapy interventions. Informed consent to participate in the research and the possibility of follow-up after the end of the intervention. Ability to communicate verbally and understand Persian.
Exclusion criteria:
Absence of concomitant psychiatric disorders (such as schizophrenia or severe personality disorders) that would prevent participation in the intervention. Having a substance use disorder or severe dependence on alcohol and drugs Having a history of suicide attempts in the past six months Receiving other similar psychological treatments at the same time (such as cognitive-behavioral therapy or other psychotherapeutic interventions) Having a debilitating physical illness that prevents you from attending therapy sessions Having severe cognitive disability or low IQ that prevents understanding and implementing therapeutic techniques
Age
From 20 years old to 50 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
In this study, 30 people will be randomly divided into two groups: intervention and control. For this purpose, a simple random assignment method will be used. First, each participant will be assigned a number. Then, these numbers will be entered into a random number generation software and based on the generated numbers, the people will be divided into two groups. People whose numbers are randomly assigned to the first group will be entered into the intervention group, and the rest will be assigned to the control group. To ensure the correct implementation of randomization and to prevent any type of bias, the allocation process will be carried out by an independent person who is not involved in the research. This randomization method ensures that each participant has an equal chance of being placed in one of the groups and that the balance in the number of people in each group is maintained.
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 Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-12-30, 1403/10/10
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.094

Health conditions studied

1

Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

Primary outcomes

1

Description
Quality of life
Timepoint
Before the start of the intervention and after completing 8 intervention sessions.
Method of measurement
World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)

2

Description
Psychological capital
Timepoint
Before the start of the intervention and after completing 8 intervention sessions.
Method of measurement
Luthans Psychological Capital Questionnaire (2007)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group will undergo a cognitive-behavioral therapy (CBT) intervention, which will be held in 8 weekly 90-minute sessions. This intervention is designed to improve the quality of life and increase the psychological capital of patients with bipolar disorder. Initially, participants will be introduced to the basic concepts of cognitive-behavioral therapy, including the role of thoughts, feelings, and behaviors in everyday experiences. Then, techniques such as identifying and correcting irrational thoughts, cognitive restructuring, and evaluating evidence are taught to change negative thought patterns. In the following stages, participants will practice emotion regulation strategies, problem-solving skills, and effective coping methods to manage their emotional reactions in stressful situations. Also, techniques to increase hope, self-efficacy, and cognitive flexibility are provided to strengthen the psychological capital of patients. Finally, the skills learned to increase quality of life, create emotional balance, prevent relapse, and improve functioning in personal and social areas are reviewed and consolidated.
Category
Treatment - Other

2

Description
Control group: This group does not receive any intervention and serves only as a comparison. Individuals in this group continue with the usual, standard care they would normally receive and do not receive any cognitive-behavioral treatment or intervention during the study.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamdeli Psychology Clinic
Full name of responsible person
Ali Mohebi
Street address
corner of Azadi 10, Azadi Street, Amirkabir Boulevard.
City
Semnan
Province
Semnan
Postal code
3519835689
Phone
+98 23 3336 1969
Email
info@hamdeliclinic.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Shahab Moradi
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
shahabmoradi66@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, Semnan 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, Semnan Branch
Full name of responsible person
Kiana Emadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Imam Reza Complex, Piroozi Blvd., Imam Reza Square
City
Semnan
Province
Semnan
Postal code
3515767961
Phone
+98 23 3337 3652
Email
kiana.emadii@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Maryam Salehyan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
maryam.salehyan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Kiana Emadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Imam Reza Complex, Piroozi Blvd., Imam Reza Square
City
Semnan
Province
Semnan
Postal code
3515767961
Phone
+98 23 3337 3652
Email
kiana.emadii@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 identifying information is removed and ensured to be non-identifiable.
When the data will become available and for how long
Data can be made available one week after the results are published.
To whom data/document is available
Study data and documentation are available to relevant academic and industrial researchers after the request is submitted and approved.
Under which criteria data/document could be used
Data and documents can be used for the purpose of studying or conducting research, provided the source is cited.
From where data/document is obtainable
If you need data, please contact kiana.emadii@gmail.com.
What processes are involved for a request to access data/document
Upon receipt of the request, the principal investigator reviews it. If approved, the data will be sent to the requester within one week, along with a commitment to maintain the privacy of the participants, maintain confidentiality, and not publish the data without mentioning the principal investigator's name.
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