Comparison of the effectiveness of self-care group training and acceptance and commitment group therapy on quality of life and psychological well-being in patients with type 2 diabetes
Comparison of the effectiveness of self-care needs-based education and acceptance and commitment group therapy on quality of life and psychological well-being in patients with type 2 diabetes
Design
The present study is a quasi-experimental and pretest-post test design with control group. Using simple randomization method in three groups based on Acceptance and Commitment Therapy (n = 20), Self-Care Needs Education (20) = n) and control group (n = 20) will be assigned.
Settings and conduct
The statistical population of the study consisted of patients with type 2 diabetes referring to Kish Island Medical Centers aged 25-45 years.
Participants/Inclusion and exclusion criteria
Inclusion criteria were: Type 2 diabetes with physician-approved for at least one year, hemoglobin A1c level above 7%, minimum age 25 and maximum 45, minimum cycle education, no psychological treatment from The time of diagnosis, absence of acute or chronic medical illness in the medical records of patients such as epilepsy, skeletal diseases, heart and respiratory failure, etc. which can cause problems in blood sampling and long sessions tolerance, lack of Severe mental illnesses such as psychotic disorders and non-use of psychotropic drugs or substance abuse are currently approved by the psychologist.
Intervention groups
Prior to the sessions and with informed consent, glycosylated hemoglobin testing will be performed for participants in both groups. They will also complete the research questionnaires. They will then receive acceptance and commitment therapy (12 sessions 90-minute per week) and self-care needs training (5 sessions 90-minute per week).
Main outcome variables
quality of life and psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045871N1
Registration date:2020-04-20, 1399/02/01
Registration timing:retrospective
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Abas Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 4447 1906
Email address
molavi79@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-10-22, 1398/07/30
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2020-03-10, 1398/12/20
Scientific title
Comparison of the effectiveness of self-care group training and acceptance and commitment group therapy on quality of life and psychological well-being in patients with type 2 diabetes
Public title
The Effect of Self-Care and Acceptance and Commitment-Based Therapy on Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria were: Type 2 diabetes with physician-approved for at least one year, hemoglobin A1c level above 7%, minimum age 25 and maximum 45, minimum cycle education, no psychological treatment from Time of diagnosis
Exclusion criteria:
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not 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
Ethics committee of Hormozgan University of Medical Sciences
Before intervention, after intervention and three months after intervention
Method of measurement
World Health Organization Quality of Life Scale
2
Description
Psychological Wellbeing
Timepoint
Before intervention, after intervention and three months after intervention
Method of measurement
Reef Psychological Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will complete the research questionnaires. She will then receive self-care training (5 90-minute sessions per week)
Category
Rehabilitation
2
Description
Intervention group: They will complete the research questionnaires. It will then undergo acceptance and commitment treatment (12 sessions of 90 minutes per week).