The Moderating role of coping style and social support in effect of Acceptance and Commitment Therapy (ACT) on HbA1c, quality of life and self-care in type II diabetics
In the present study, Acceptance and Commitment Therapy (ACT) is considered an effective intervention to achieve the treatment goal of diabetes that of maintaining close to normal range of glycosylated hemoglobin and the prevention of its complications. For this purpose, after applying inclusion criteria, 100 type II diabetic patients will be randomly assigned to two groups (n = 50). Participants in the experimental group, besides continuing medication treatment as usual and a 1-day education workshop, will participate in Acceptance and Commitment therapy for 10 sessions, once a week. Participants in the control group will continue medication as usual and will receive a 1-day educational workshop. At baseline, glycosylated hemoglobin (HbA1c) test will be measured from participants of the two groups and several questionnaires will be administered, including the Summary of Diabetes Self-Care Activities (SDSCA), The audit of diabetes-dependent quality of life (ADDQoL) and Multidimensional Scale of Perceived Social Support (MSPSS) and The brief COPE Questionnaire (COPE). After 3 months of completion of the study, all participants will have glycosylated hemoglobin (HbA1c) test for the second time and will complete all baseline questionnaires in addition to the Acceptance and Action Diabetes Questionnaire (AADQ). Finally, the effect of acceptance and commitment therapy on improving the symptoms of diabetes will be assessed via data analysis through Ancova and hierarchical regression statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091710860N1
Registration date:2013-02-02, 1391/11/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-02, 1391/11/14
Registrant information
Name
Zeinab Shayeghian
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
shayeghian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University scholarship + Personal source
Expected recruitment start date
2013-03-01, 1391/12/11
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Moderating role of coping style and social support in effect of Acceptance and Commitment Therapy (ACT) on HbA1c, quality of life and self-care in type II diabetics
Public title
The effect of Acceptance and Commitment Therapy (ACT) on treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- age range is between 40 to 60 years old; 2- Minimum educational degree is Diploma; 3- disease duration is between one and five years; 4 - It is necessary that the subjects during the study don't use psychotherapy programs and Drug changes outside of the educational and therapeutic intervention of study. Exclusion criteria: 1 - Being affected by other types of diabetes; 2- Being affected by severe diabetic complications that may impede the investigation.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tarbiat Modares University
Street address
Nasr Bridge, Cross of Chamran and Jalal Al Ahmad
City
Tehran
Postal code
Approval date
2012-12-15, 1391/09/25
Ethics committee reference number
52/3424د
Health conditions studied
1
Description of health condition studied
typeII Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self Care
Timepoint
before treatment. after treatment. 3 months after treatment
Method of measurement
Summary of Diabetes Self-Care Activities toobert and et al 2002
Secondary outcomes
1
Description
HbA1c
Timepoint
befor treatment. after treatment. 3 months after treatment
Method of measurement
blood tests Mg/dl
2
Description
Quality of life
Timepoint
befor treatment. after treatment. 3 months after treatment
Method of measurement
The audit of diabetes-dependent quality of life (ADDQoL)
Intervention groups
1
Description
It is a group therapy intervention. ACT treatment will be implemented in 8 session and three phases, as follows: The first phase (sessions 3-1) education and information, in this phase, patients, after communication of the therapist and patient to each other, receive extensive information about diabetes (diet, exercise, stress, etc.) and its complications, and effects of psychological factors on control and reversion and ACT concepts. The second phase (sessions 6-4) coping and stress management, it's about avoidance of coping with diabetes and self-care. The third phase (10-7) to accept and act, it's training of acceptance and educational elements of treatment and values.
Category
Lifestyle
2
Description
Participants in the control group will continue medication as usual and will receive a 1-day educational workshop.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Dr Kobra Roohi Gilani
Street address
Labbafinejad Clinic, Ninth Bostan, Pasdaran Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Ma'someh Darabi
Street address
Tarbiat Modares University, Humanities Faculties
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Research Institute for Endocrine Sciences
Full name of responsible person
Dr Parisa Amiri
Position
Assistant
Other areas of specialty/work
Street address
No 24, Parvaneh Street, Yaman Street, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
parisaamiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Zeinab Shayeghian
Position
PhD student of Psychology
Other areas of specialty/work
Street address
Tarbiat Modares University, Nasr Bridge, cross of Chamran and Jalal Al Ahmad