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Study of the effectiveness of cognitive behavioral group therapy on perceived stress, emotional resilience, and meaning of life in women with type 2 diabetes

Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral group therapy on perceived stress, emotional resilience, and meaning in life in women with type 2 diabetes
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 40 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population of this study will comprise all women diagnosed with Type 2 diabetes who visit Shafa Hospital in Ahvaz during the specified study period and receive a definitive diagnosis from a specialist. A convenience sampling method will be employed during the sampling stage. Once a sample size of 40 participants is reached, they will be randomly assigned to either the ‘Cognitive-Behavioral Therapy’ group (intervention group) or the ‘Waitlist’ group (control group), based on the predefined inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 40 years, women with type 2 diabetes with a definitive diagnosis from a specialist physician. Inclusion criteria: Participation in other psychotherapy sessions 6 months prior to the study, unwillingness to participate in the research.
Intervention groups
Intervention group: They will receive cognitive-behavioral therapy intervention. Cognitive behavioral therapy by Douglas and Robbie Chaud (2007), Tarjomehforooshan and Abedian (2014) will be administered to the experimental group in 8 90-minute sessions, two sessions per week. The therapeutic tools used will include cognitive model training, cognitive restructuring, relaxation techniques, and stress management. Control group: They will not receive any intervention.
Main outcome variables
Perceived stress, Emotional resilience, Meaning of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260608069712N1
Registration date: 2026-08-01, 1405/05/10
Registration timing: prospective

Last update: 2026-08-01, 1405/05/10
Update count: 0
Registration date
2026-08-01, 1405/05/10
Registrant information
Name
Mehrsa Balalzadeh
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 8542
Email address
mehrsa.balalzadeh@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-06, 1405/05/15
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of cognitive behavioral group therapy on perceived stress, emotional resilience, and meaning of life in women with type 2 diabetes
Public title
The role of cognitive-behavioral therapies in promoting resilience and meaning in life in women with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 40 years Definitive diagnosis of type 2 diabetes by a specialist doctor
Exclusion criteria:
Participation in other psychotherapy sessions in the 6 months prior to the study Unwillingness to participate in research
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of this study will include all women with type 2 diabetes who visit the hospital within the specified time period for the study and are given a definitive diagnosis of the disease by a specialist physician. In the sample selection stage, the available sampling method will be used. After selecting a sample size of 40 people, based on the study's entry and exit criteria, the participants will be randomly assigned to two groups: "cognitive-behavioral therapy" (intervention group) and "waiting list" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). The envelope will be opened and the allocation group will be informed only when each participant enters the study. To ensure the equality of baseline variables (such as anxiety level, age, and length of marriage), their distribution in the two groups will be examined during the statistical analysis stage.
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 Islamic Azad University, Ahvaz Branch
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-04-28, 1405/02/08
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.082

Health conditions studied

1

Description of health condition studied
Typw 2 Diabeted mellitus
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications

Primary outcomes

1

Description
Perceived stress
Timepoint
1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session.
Method of measurement
The method of measurement will be the Cohen et al. (1983) Perceived Stress Questionnaire.

2

Description
Emotional resilience
Timepoint
1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session.
Method of measurement
The measurement method will be using the Connor and Davidson (2003) Emotional Resilience Scale.

3

Description
The meaning of life
Timepoint
1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session.
Method of measurement
The measurement method will be using the Meaning of Life Questionnaire by Steger et al. (2006).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive-behavioral therapy intervention; Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: Cognitive model training (connection of thoughts, feelings, and behaviors); Cognitive restructuring (identifying and challenging automatic thoughts); Relaxation and stress management techniques; Problem-solving exercises; and value-based activities to promote meaning in life. Summary of session content: Session 1: Pre-test, familiarization with the cognitive-behavioral model, and training on the relationship between diabetes, negative thoughts, and stress; Session 2: Identification of automatic thoughts and cognitive biases related to the disease and stress management; Session 3: Training in relaxation techniques (such as deep breathing) to reduce perceived stress; Session 4: Cognitive restructuring and challenging dysfunctional thoughts about the limitations caused by diabetes; Session 5: Training in problem-solving skills and coping with everyday challenges of diabetes management; Session 6: Behavioral exercises to increase emotional resilience in the face of physical changes; Seventh session: Focusing on finding meaning in life and identifying personal values ​​amid the challenges of the disease; Eighth session: Conclusion, teaching planning to prevent the return of stress, conducting a post-test, and determining the time for the follow-up test.
Category
Treatment - Other

2

Description
Control group: The control group will not receive any intervention during the research. However, to avoid factors that threaten the internal validity of the research, such as compensatory competition of the control group or demoralization, they are assured that they will receive the intervention at the next time (after data collection).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mehrsa Balalzadeh
Street address
Shafa Hospital, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6133743281
Phone
+98 61 3374 3281
Email
mehrsa.balalzadeh@iau.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aslan Egdarnezhad
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
a_eigder@ymail.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
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
Mehrsa Balalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
West 6th Street, Kianabad
City
Ahvaz
Province
Khouzestan
Postal code
6155714719
Phone
+98 61 3391 8542
Email
mehrsa.balalzadeh@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrsa Balalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
West 6th Street, Kianabad
City
Ahvaz
Province
Khouzestan
Postal code
6155714719
Phone
+98 61 3391 8542
Email
mehrsa.balalzadeh@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrsa Balalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
West 6th Street, Kianabad
City
Ahvaz
Province
Khouzestan
Postal code
6155714719
Phone
+98 61 3391 8542
Email
mehrsa.balalzadeh@iau.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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