Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral group therapy compared to optimism training on depression, anxiety, optimism, and hope in hemodialysis patients
Design
A randomized, single-blind, three arm, parallel-group, controlled clinical trial with 25 patients in each group. Randomization process will be performed using the Block Randomization method.
Settings and conduct
This clinical trial will be conducted at the Taleghani, Imam Hossein, Loghman-e Hakim, and Shohadaye Tajrish hospitals in Tehran. The Patients will be blinded to their allocation to the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) A documented diagnosis of hemodialysis 2) Willingness to participate in the research Exclusion criteria: 1) Non-consumption of psychotropic medications 2) Excessive disability that would prevent participation in the classes
Intervention groups
Patients in the intervention groups will receive training for 8 90-minute sessions (one session per week for 8 consecutive weeks). The content of training in cognitive behavioral group therapy includes training in recognizing negative automatic thoughts in difficult and unfortunate situations, reframing exercises for negative thoughts, analyzing negative thoughts and coping strategies, and a guide to self-treatment and relapse prevention. In the optimism training group, it will include insight into optimism and its monitoring, optimism and growth after injury, positive interpretation of the previous complication and the logic of addressing it, seeing the positive characteristics of each phenomenon, optimism in social relationships, optimism over time, optimistic explanations of events, and turning optimism into a habit. Patients in the control group will receive routine hospital education.
Main outcome variables
Depression; Anxiety; Optimism; Hope

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240609062065N4
Registration date: 2025-12-01, 1404/09/10
Registration timing: retrospective

Last update: 2025-12-01, 1404/09/10
Update count: 0
Registration date
2025-12-01, 1404/09/10
Registrant information
Name
Amir mohamad Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 095 7427
Email address
nazari.amir7009@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
2024-09-22, 1403/07/01
Actual recruitment end date
2025-03-21, 1404/01/01
Trial completion date
2025-05-22, 1404/03/01
Scientific title
Comparing the effectiveness of cognitive behavioral group therapy and optimism training on depression, anxiety, optimism, and hope in hemodialysis patients
Public title
Comparing the effectiveness of cognitive behavioral group therapy and optimism training in hemodialysis patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
A documented diagnosis of hemodialysis Willingness to participate in the research
Exclusion criteria:
Non-consumption of psychotropic medications Excessive disability that would prevent participation in the classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 75
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the participants will be selected through convenience sampling and then will be assigned to three groups of cognitive behavioral group therapy, optimism training, and control groups, 25 individuals per group). Using a randomized block design (6-individual blocks, www.randomizer.org), random sequences of letters A, B, and C will be created, which will assign the samples to one of the three desired groups. All participants will receive sealed, opaque, sequentially numbered envelopes to conceal the allocation sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patients will not be aware of their allocation into the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Koodakyar deadend, Daneshjou Boulevard, Yaman street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.SBMU.PHNS.REC.1403.028

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
Depression
Timepoint
Before the intervention, immediately after the intervention, and two months later
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

2

Description
Anxiety
Timepoint
Before the intervention, immediately after the intervention, and two months later
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

3

Description
Optimism
Timepoint
Before the intervention, immediately after the intervention, and two months later
Method of measurement
Life Orientation Test (LOT)

4

Description
Hope
Timepoint
Before the intervention, immediately after the intervention, and two months later
Method of measurement
Schneider's Hope Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention groups will receive training for 8 90-minute sessions (one session per week for 8 consecutive weeks). The content of training in cognitive behavioral group therapy includes training in recognizing negative automatic thoughts in difficult and unfortunate situations, reframing exercises for negative thoughts, analyzing negative thoughts and coping strategies, and a guide to self-treatment and relapse prevention. In the optimism training group, it will include insight into optimism and its monitoring, optimism and growth after injury, positive interpretation of the previous complication and the logic of addressing it, seeing the positive characteristics of each phenomenon, optimism in social relationships, optimism over time, optimistic explanations of events, and turning optimism into a habit.
Category
Other

2

Description
Control group: Patients in the control group will receive routine hospital education.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
ehmc.sbmu.ac@gmail.com

2

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahrdari St
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Kamali St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

4

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Arabi St
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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