Effectiveness of behavioral activation therapy based on changing lifestyles for depression symptoms, psychological well-being and Feelings of guilt in children between 7-15 years old with diabetes
The aim of this study is to determine effectiveness of behavioral activation therapy based on changing lifestyles for depression, psychological well-being and Feelings of guilt in children aged between 7-15 with diabetes in two experimental and control groups. The main inclusion criteria are: having diabetes (Type 1 and 2) for at least one year and without major psychiatric disorder. The main exclusion criteria are: need a significant change in insulin dose during the research and acute or chronic medical illness.The study population included all patients aged 7-15 that referred to the diabetes association of Tabriz of whom 34 participants were selected using convenient sampling. They were randomly allocated into two equal groups (experimental and control). Therapy sessions will be in 8 weeks and every week a session lasted 90 minutes. The control group did not receive any intervention. The primary outcomes of the study will include the three variables of depression, psychological well-being and feelings of guilt.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012616602N4
Registration date:2015-02-04, 1393/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Vahid Ataie Moghanloo
Name of organization / entity
Payam Noor University of Parsabad Moghan
Country
Iran (Islamic Republic of)
Phone
+98 45 2882 2371
Email address
vahidataie_3000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Payam Noor University of Parsabad Ardabil
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of behavioral activation therapy based on changing lifestyles for depression symptoms, psychological well-being and Feelings of guilt in children between 7-15 years old with diabetes
Public title
Effectiveness of behavioral activation therapy in children with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age less than 15 years; having diabetes (Type 1 and 2) for at least one year; without major psychiatric disorder; Exclusion criteria: need a significant change in the insulin dose during the research; acute or chronic medical illness; receiving psychiatric treatments or use of psychotropic drugs; drug abuse during the study period.
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Payam Noor University of Pars Abad Ardabil
Street address
Building No. 1, Number 24, St. Daneshgah, Pars Abad, Ardabil
City
Parsabad
Postal code
5675151548
Approval date
2011-07-01, 1390/04/10
Ethics committee reference number
23285
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Depression
Timepoint
Before intervention and two months after start of intervention
Method of measurement
Reynolds Child Depression Scale
2
Description
Psychological well-being
Timepoint
Before intervention and two months after start of intervention
Method of measurement
Satisfaction with Life Scale
3
Description
Feelings of Guilt
Timepoint
Before intervention and two months after start of intervention
Method of measurement
Eysenck Feelings of Guilt Scale
Secondary outcomes
empty
Intervention groups
1
Description
Process of group therapy will be done on the experimental group in 8 sessions and 90 minutes (Once a week). 1- The training of simple behavioral contracts. 2- The training of behavioral activation and focus on behavioral activation in interaction between individual and the environment. 3- The psychological training in the case of healing processes in a group. 4- In the fourth session the focused was on anxiety aspects of diabetes and expressing positive and hopeful sentences about the small improvements in patient. 5- The focus on the anxiety aspects of diabetes. 6- The focus on the recurrence symptoms of anxiety in patients. 7- Training of patient regarding coping skills, and training of cognitive reconstruction. 8- In the end wrapping, summary of treatment and providing the preventive strategies were done.
Category
Behavior
2
Description
The control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Diabetes Association
Full name of responsible person
Mr Mehdi Haghighi
Street address
Number 46, Fatemi St. Northern Ghatran, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payam Noor University of Pars Abad Ardabil
Full name of responsible person
Mr Mousa Moazzezi
Street address
Building No. 1, Number 24, St. Daneshgah, Pars Abad, Ardabil
City
Pars Abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payam Noor University of Pars Abad Ardabil
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
Payam Noor University of Pars Abad Ardabil
Full name of responsible person
Vahid Ataie Moghanloo
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
Department of Psychology, Payam Noor University, Pars Abad, Ardabil
City
Pars Abad
Postal code
5675151548
Phone
+98 45 2882 2371
Fax
+98 45 2882 3557
Email
vahidataie_3000@yahoo.com
Web page address
http://parpnu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Payam Noor University of Pars Abad Ardabil
Full name of responsible person
Vahid Ataie Moghanloo
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
Department of Psychology, Payam Noor University, Pars Abad, Ardabil
City
Pars Abad
Postal code
5675151548
Phone
+98 45 2882 2371
Fax
+98 45 2882 3557
Email
vahidataie_3000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Payam Noor University of Pars Abad Ardabil
Full name of responsible person
Vahid Ataie Moghanloo
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
Department of Psychology, Payam Noor University, Pars Abad, Ardabil
City
Pars Abad
Postal code
5675151548
Phone
+98 45 2882 2371
Fax
+98 458823557
Email
vahidataie_3000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)