Protocol summary
-
Study aim
-
Determining the effectiveness of group-based optimism training compared to cognitive behavioral therapy on depression, anxiety, optimism, and hope in hemodialysis patients
-
Design
-
A three arm, parallel-group, randomized controlled clinical trial with 45 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 Imam Hossein and Ayatollah Taleghani hospitals in Tehran.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
1) Having a confirmed diagnosis of hemodialysis by a nephrologist
2) Willingness to participate in the research
Exclusion criteria:
1) Having a confirmed diagnosis of a psychological disorder by a psychiatrist
2) Excessive disability that would prevent participation in the classes
-
Intervention groups
-
Patients in the intervention groups will receive training for eight 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
-
The study protocol was updated to correct methodological shortcomings.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20240609062065N4
Registration date:
2025-12-01, 1404/09/10
Registration timing:
retrospective
Last update:
2026-07-09, 1405/04/18
Update count:
1
-
Registration date
-
2025-12-01, 1404/09/10
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-09-22, 1403/07/01
-
Expected recruitment end date
-
2025-05-22, 1404/03/01
-
Actual recruitment start date
-
2024-09-22, 1403/07/01
-
Actual recruitment end date
-
2025-05-22, 1404/03/01
-
Trial completion date
-
2025-08-23, 1404/06/01
-
Scientific title
-
Comparing the effectiveness of group-based optimism training and cognitive behavioral therapy on depression, anxiety, optimism, and hope in hemodialysis patients
-
Public title
-
Comparing the effectiveness of group-based optimism training and cognitive behavioral therapy in hemodialysis patients
-
Purpose
-
Other
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Having a diagnosis of hemodialysis by a nephrologist
Willingness to participate in the research
Exclusion criteria:
Having a confirmed diagnosis of a psychological disorder by a psychiatrist
Excessive disability that would prevent participation in the classes
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
135
Actual sample size reached:
135
-
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 group-based optimism training, cognitive behavioral therapy, and control, 45 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)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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 and four 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 and four 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 and four months later
-
Method of measurement
-
Life Orientation Test (LOT)
4
-
Description
-
Hope
-
Timepoint
-
Before the intervention, immediately after the intervention, and two months and four months later
-
Method of measurement
-
Snyder's Hope Scale
Intervention groups
1
-
Description
-
Intervention group: Patients in the intervention groups will receive training for eight 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
1
-
Sponsor
-
-
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
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