Finding the effectiveness of acceptance and Commitment Group Training (ACT) and Emotion Regulation Group Training on Glycemic control index (HbA1c, diabetic quality of life and empowerment in patients diagnosed with type2 diabetes.
Finding the effectiveness of Acceptance and Commitment Group Training (ACT) and Emotion Regulation Group Training on Glycemic control index (HbA1c), Diabetic Quality of life and Empowerment in Patients diagnosed with type 2 Diabetes.
Design
Treatment consisted of: two experiment groups and one control group, not blinded, using available sampling method and randomly divided in three groups (acceptance and commitment-based therapy: 15 patients, emotion regulation: 15 patients and control group: 15 patients.
Settings and conduct
English
The main purpose of this study is supportive study is to compare therapeutic methods: within groups; Acceptance and Commitment therapy group and Emotion Regulation and control group, on hemoglobin glucose, diabetic quality of life and empowerment in patients with
Type 2 diabetes. these two treatments are studied within two experimental groups and the control group did not received any treatment. the study was not blinded. Corona Virus Pandemic coincidence with the Study and the need of the study groups to be in quarantine, training sessions are held virtually.
Participants/Inclusion and exclusion criteria
1.Conscious consent to participate in research 2. Age range 40-60 3. Not participating in other similar researches at the same time 4. Being at least 8 years under graduation 5. Being at least 2 years diagnosed with type 2 diabetes by a doctor 6. No psychiatric disorders
Intervention groups
Acceptance and commitment group training: 8 sessions of 90 minutes.
Emotion regulation group training: 8 sessions of 90 minutes.
Main outcome variables
Hemoglobin Glucose: Blood Serum Level Test, Diabetic Quality of Life: Diabetic Quality of Life Questionnaire (DQOL), Empowerment: Diabetes Empowerment Scale (F-DES-28).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047677N1
Registration date:2020-08-17, 1399/05/27
Registration timing:retrospective
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Elham Eghrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 6529
Email address
elham.eghrari@iautj.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-18, 1398/11/29
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2020-02-19, 1398/11/30
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-09-10, 1399/06/20
Scientific title
Finding the effectiveness of acceptance and Commitment Group Training (ACT) and Emotion Regulation Group Training on Glycemic control index (HbA1c, diabetic quality of life and empowerment in patients diagnosed with type2 diabetes.
Public title
Effectiveness of Psychologic therapies on psychological symptoms and hemoglobin glucose in patients diagnosed with type2 diabetes.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40_60
Being at least 8 years under graduation
Being at least 2 years diagnosed with type 2 diabetes by a doctor
Conscious consent to participate in research
No psychiatric disorders
Not participating in other similar researches at the same time
Exclusion criteria:
More than 2 sessions absence of in training sessions
Suffering other acute medical disease
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:
45
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
To select a sample, after preparing a list of those who refer to the Khorasan Razavi Diabetes Association and contact them, 45 people who meet the criteria for participating in the research will be selected.The selected members will be randomly divided into 3 groups and there will be 15 people in each group. Random allocation of the research sample to two intervention groups and a control group will be done based on six permuted blocks so that in each six block, two allocations to intervention group one, two allocations to intervention group two and two allocations to control group will be allocated. In this case, a total of 36 blocks are created, each block is numbered with a number and then the number of six blocks id selected base on the random numbers table until the sample size reaches 45 and finally 15 people in each group are assigned.
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 Azad University of Torbate Jam
Before the intervention (pretest), immediately after the intervention (post test), three month after the intervention(follow up)
Method of measurement
Serum Hemoglobin Glucose Level test
2
Description
Diabetic quality of life
Timepoint
Before the intervention (pretest), immediately after the intervention (post test), three month after the intervention(follow up)
Method of measurement
Diabetic Quality of life Questionnaire
3
Description
Empowerment
Timepoint
Before the intervention (pretest), immediately after the intervention (post test), three month after the intervention(follow up)
Method of measurement
the Diabetes Empowerment scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Acceptance and Commitment Group training. Intervention method: Protocol is based on Acceptance and Commitment therapy of Hayes et al., Which will be held in 8 sessions of 90 minutes for 8 consecutive weeks.
Category
Behavior
2
Description
Second intervention group: Emotion Regulation training. Intervention method: Training of emotion regulation sessions based on the protocol of Barlow et al., Which will be held in 8 sessions of 90 minutes in 8 consecutive weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
International Iranian Diabetes Prevention and Control Foundation