Investigating the effect of acceptance and commitment therapy on diabetes management self-efficacy and psychological well-being in elderly people with diabetes:a randomized controlled clinical trial
Determining the effect of acceptance and commitment therapy on diabetes management self-efficacy and psychological well-being in elderly people with diabetes
Design
This study is a randomized clinical trial without blinding.
Settings and conduct
This study is a randomized clinical trial without blinding that will be conducted at the diabetes clinic at Vali Asr Hospital, Fasa University of Medical Sciences.
Participants/Inclusion and exclusion criteria
This study will enroll 60 elderly patients with diabetes. Inclusion criteria include willingness to participate in the study, age over 65 years, ability to attend educational sessions, literacy, and diagnosis and confirmation of diabetes by an endocrinologist. Exclusion criteria will include perceptual and cognitive impairments.
Intervention groups
The educational intervention program will be implemented in 6 sessions of 90 minutes each, two days a week for 3 weeks. The educational sessions will use lecture, group discussion, question and answer, and brainstorming methods. The educational sessions include the first session of introduction and training on acceptance and commitment therapy, the second session of creating flexible patterns of behavior through value-based exposure, the third session of moving towards a valuable life with an accepting and observant self, the fourth session of strategies for responding to intrusive and stressful thoughts, the fifth session of self-awareness and self-control behaviors, and the sixth session of setting goals based on values and taking effective actions to achieve those goals and stay on the path of values.
Main outcome variables
Diabetes management self-efficacy and Psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N13
Registration date:2025-09-07, 1404/06/16
Registration timing:prospective
Last update:2025-09-07, 1404/06/16
Update count:0
Registration date
2025-09-07, 1404/06/16
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acceptance and commitment therapy on diabetes management self-efficacy and psychological well-being in elderly people with diabetes:a randomized controlled clinical trial
Public title
Investigating the effect of acceptance and commitment therapy on psychological well-being and management self-efficacy in elderly people with diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 65 years old
Ability to participate in training sessions
Being literate in reading and writing
Diagnosing and confirming diabetes with an endocrinologist
Willingness to participate in the study
Exclusion criteria:
Having perceptual and cognitive disorders
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 cards are placed in a sealed envelope. 30 cards are put on stickers (A intervention group) and labels are placed on other 30 cards (B control group). Then the patients participating in the study are asked to take one of the cards. People who take card A will be in the intervention group and people who take card B will be in the control group.
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 Fasa University of Medical Sciences
Street address
Fars Province. Fasa City. Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2025-08-04, 1404/05/13
Ethics committee reference number
IR.FUMS.REC.1404.117
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Diabetes management self-efficacy
Timepoint
Before, immediately and three months after training
Method of measurement
Diabetes Management Self-Efficacy Questionnaire by Bijl et al.
2
Description
Psychological well-being
Timepoint
Before, immediately and three months after training
Method of measurement
Psychological Well-Being Questionnaire by Riff et al.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The educational program will be implemented in the form of 6 sessions of 90 minutes each session and two days a week for 3 weeks. Lectures, group discussions, questions and answers, and brainstorming methods are used in the training sessions by a psychologist who has already completed the training course. In this research, the general treatment guide based on acceptance and commitment will be used. Acceptance and commitment therapy is a psychotherapy technique that promotes acceptance of negative thoughts, feelings, and events. In fact, this psychotherapy technique encourages a person to consciously participate in activities. The training sessions include the first session of familiarization and training regarding treatment based on acceptance and commitment, the second session of creating flexible patterns of behavior through value-oriented encounter, the third session of moving towards a valuable life with an accepting and observant self, the fourth session of ways to respond to thoughts Disturbing and stressful, the fifth session is self-awareness and self-control behaviors, the sixth session is setting goals based on values and taking effective measures to achieve those goals and stay on the path of values.
Category
Lifestyle
2
Description
Control group: The control group will only receive the educational package and will not receive the educational intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Mostafa Bijani
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mojtaba Farjam
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
farjam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5334 2311
Email
bizhani_mostafa@yahoo.con
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5334 2311
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5334 2311
Email
bizhani_mostafa@yahoo.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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All the questionnaires used in this study as well as the content of the training program will be provided to the applicants.
When the data will become available and for how long
The time period for accessing the data is after the publication of the article extracted from the study and there is no time limit.
To whom data/document is available
Researchers, nursing managers, and hospital management can send their requests for using the results of this study to the corresponding author, Mostafa Bijani, in writing. Phone number 09173308451
Email bizhani_mostafa@yahoo.com
Under which criteria data/document could be used
Nursing managers can use the results of this study to develop educational programs for elderly patients with diabetes as well as their families.
From where data/document is obtainable
Researchers, nursing managers, and hospital management can send their requests for using the results of this study to the corresponding author, Mostafa Bijani, in writing. Phone number 09173308451
Email bizhani_mostafa@yahoo.com
What processes are involved for a request to access data/document
Sending the request for the use of research documents and results to the responsible author and sending the results by the responsible author to the requesting person Tell: 09173308451 Email:bizhani_mostafa@yahoo.com