The effectiveness of acceptance and commitment therapy on psychosocial adjustment and diabetes annoyance in patients with type 2 diabetes
Design
This clinical trial has a control group, with parallel groups, randomized, without blinding will be performed on 30 people (men and women) with type 2 diabetes. Random allocation software is used for randomization.
Settings and conduct
This research is a quasi-experimental study that was performed to determine the effective effect of third-wave therapy on the studied variables of the face in Bojnourd and psychological clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Receive a definite diagnosis of type 2 diabetes from the relevant specialist;
Conscious consent to participate in research;
at least diploma education;
Age between 59 to 40 years.
Non-inclusion criteria: other acute or chronic disorders
Intervention groups
Intervention group: people with type 2 diabetes will undergo acceptance and commitment-based therapy (ACT) for 10 sessions of 120 minutes (two sessions per week) for 74 days. Control group: This group will not receive any intervention.
Main outcome variables
Psychosocial adjustment; diabetes distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210525051395N1
Registration date:2021-07-17, 1400/04/26
Registration timing:prospective
Last update:2021-07-17, 1400/04/26
Update count:0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
mohammad taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3232 4681
Email address
mo.taheri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of acceptance and commitment therapy on psychosocial adjustment and diabetes distress in patients with type 2 diabetes
Public title
The effectiveness of acceptance and commitment therapy on psychosocial adjustment and diabetes distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Receive a definite diagnosis of type 2 diabetes from the relevant specialist
Conscious consent to participate in research
Minimum diploma education
Age between 59 to 40 years
Exclusion criteria:
Other acute or chronic disorders
Age
From 40 years old to 59 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
Randomization in this study will be based on a simple random method. Therefore, each patient is randomly assigned a number by a table of random numbers, based on which, if it is an odd number; the patient in the intervention group and if the number is even; the patient 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 Tehran University of Social Welfare and Rehabilitation Sciences
Street address
Koodkiar dead end alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.USWR.REC.1400.029
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Psycho-social adjustment
Timepoint
Before intervention; after intervention and follow-up after 3 months
Method of measurement
Psychosocial adjustment questionnaire
2
Description
Diabetes distress
Timepoint
Before intervention; after intervention and follow-up after 3 months
Method of measurement
Diabetes distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy for self-management of type 2 diabetic patients, which was presented by the founders of this treatment in 2004. It has five main axes that are performed on the medical, psychological, and self-care aspects of diabetes. the Patients in this group will receive acceptance and commitment treatment in 10 120-minute sessions (one session per week) for 74 days.
Category
Treatment - Other
2
Description
Control group: Here we have 15 people on whom pre-test and post-test are performed but no intervention is performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Hor Health Center
Full name of responsible person
Ibrahim Bazkhanei
Street address
Hor Street; in front of Taamin-e-Ejtemaei Hospital; Chamran Street
City
Bojnurd
Province
North Khorasan
Postal code
9413875199
Phone
+98 58 3222 1444
Email
mb.bojnourd@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Koodkiar dead end alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Taheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation counseling
Street address
No. 51, Iqbal 14, Vahdat 8, south side of airport, West Taleghani Street
City
Bojnurd
Province
North Khorasan
Postal code
9411111111
Phone
+98 58 3232 4681
Email
taherimoh73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Taheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation counseling
Street address
No. 51, Iqbal 14, Vahdat 8 alley, south side of airport, West Taleghani Street
City
Bojnurd
Province
North Khorasan
Postal code
9419843174
Phone
+98 58 3232 4681
Email
taherimoh73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Taheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation counseling
Street address
No. 51, Iqbal 14, Vahdat 8 alley, south side of airport, West Taleghani Street
City
Bojnurd
Province
North Khorasan
Postal code
9419843173
Phone
+98 58 3232 4681
Email
taherimoh73@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