The aim of this study is to determine effectiveness of Acceptance and Commitment Therapy (ACT) on self-care, self-efficacy, and emotional distress in type 2 elder diabetes patients, Yazd in two experimental and control groups. The main inclusion criteria are: being over 60 years old; having diabetes type 2 for more than a year. The main exclusion criteria are: having severe mental problem; receiving any psychological treatment in the past year; the use of narcotic drugs and drug abuse in the past month. 80 elderly patients with type II diabetes, by taking inclusion and exclusion criteria will be randomly selected And randomly assigned to experimental and control groups of 40, then to teach subjects in the intervention group were randomly divided into two groups of 20 persons. Before the intervention questionnaire 4 wish to pre-test will be given to both groups. Following the intervention (act) for experimental group in the form of group meetings, 8 sessions will be executed, while the control group did not receive treatment. The questionnaires were completed again after the end of the sessions and then again two month after (follow-up test) for measuring the maintaining of the effect of therapeutic intervention by the experimental and the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071028873N1
Registration date:2017-06-29, 1396/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
zahra maghsoudi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd
Country
Iran (Islamic Republic of)
Phone
+98 917 153 4268
Email address
zahra-maghsoudi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acceptance and Commitment Therapy on Self-care, Self-efficacy, and Emotional Distress in Type 2 Elder Diabetes Patients, Yazd
Public title
The Effect of Acceptance and Commitment Therapy on Self-care, Self-efficacy, and Emotional Distress in Type 2 Elder Diabetes Patients, Yazd
Purpose
Treatment
Inclusion/Exclusion criteria
The Criteria for Inclusion in the Study Were: being over 60 years old; having diabetes type 2 for more than a year; Being able to read and write and willingness to participate in the study. exclusion criteria were: having severe mental problem such as depression; receiving any psychological treatment in the past year; having sever complications resulted from diabetes such as diabetic foot; severe ulcer; amputation, the use of narcotic drugs and drug abuse in the past month.
Age
From 60 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Bahonar square- Shahid Sadoughi University of Medical Sciences
City
YAZD
Postal code
8916978477
Approval date
2016-05-02, 1395/02/13
Ethics committee reference number
IR.SSU.REC.1395.15
Health conditions studied
1
Description of health condition studied
The Effect of Acceptance and Commitment Therapy on Self-care, Self-efficacy, and Emotional Distress in Type 2 Elder Diabetes Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self Care
Timepoint
Before, After and Two Month After Untervention
Method of measurement
(SDSCA (Summary of Diabetes Self-care Activities)
2
Description
Self Efficacy
Timepoint
Before, After and Two Month After Untervention
Method of measurement
Diabetic Self Efficacy
3
Description
Emotional Distress
Timepoint
Before, After and Two Month After Untervention
Method of measurement
Diabetes Distress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Acceptance and Commitment Therapy (ACT) is carried out by one Clinical Psychologist and one Nurse in 8 Sessions, Once a Week, Each Session Lasts 90 Minutes.
Category
Behavior
2
Description
No Action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Zahra Maghsoudi
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Amir Hoshang Mehrparvar
Street address
Shahid Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & Midwifery
Full name of responsible person
Zahra Maghsoudi
Position
Elderly Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd
Postal code
Phone
+98 71 4440 2377
Fax
Email
Maghsoudi.zahra89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences , School of Nursing & Midwifery
Full name of responsible person
Dr. Javadi Mostafa
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Bu Ali St, Timsar Falahi Ave, Safaeyeh, Yazd
City
Yazd
Postal code
8916877443
Phone
+98 35 3825 8404
Fax
Email
Javadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & Midwifery
Full name of responsible person
Zahra Maghsoudi
Position
Elderly Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd
Postal code
Phone
+98 71 4440 2377
Fax
Email
Maghsoudi.zahra89@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)