(1) Objectives: The aim of this study is to examine the effect of cognitive behavioral group psychotherapy on emotion regulation strategies of adolescents with youth bipolar in Euthymic Phase. (2) Design: This research is an experimental study with “pre-test, post-test and follow-up with control group” design. (3) Setting and conduct: The sample size of this study estimated 70 persons that randomly 35 persons in control group and 35 persons in experimental group allocated. Instruments for data gathering are Demographic Questionnaire and Cognitive Emotion Regulation Questionnaire. (4) Participants including major eligibility criteria: Patients with diagnosis of early onset bipolar disorder; with age range 12 to 18 years old; have the ability to listen and sit in group therapy sessions; have the ability to respond to written questions; patients who are in the euthymic phase of bipolar disorder and according to the diagnosis of psychiatrist do not have any other physical illness or mental disorder. Exclusion Criteria including the patients who discharge before the completion of group therapy sessions; The absence of more than two sessions of group therapy. (5) Intervention: Firstly the pre-test will be done in both groups. The experimental group will attend 12 sessions of 90 minutes in group therapy. The control group will not receive any intervention in this duration. Then the post-test and follow up respectively one week and three months after intervention will be done in both groups and then the results of two groups will be compared with together. (6) The main outcome variable: Increasing use of adaptive cognitive emotion regulation strategies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506286834N8
Registration date:2015-08-21, 1394/05/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice- Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Behavioral Group Psychotherapy on Cognitive Emotion Regulation Strategies of Adolescents with Youth Bipolar in Euthymic Phase
Public title
The Effect of Cognitive Behavioral Group Psychotherapy on Cognitive Emotion Regulation Strategies of Adolescents with Youth Bipolar in Euthymic Phase
Purpose
Prevention
Inclusion/Exclusion criteria
Participants including major eligibility criteria: Patients with diagnosis of early onset bipolar disorder; with age range 12 to 18 years old; have the ability to listen and sit in group therapy sessions; have the ability to respond to written questions; patients who are in the euthymic phase of bipolar disorder and according to the diagnosis of psychiatrist do not have any other physical illness or mental disorder. Exclusion Criteria including the patients who discharge before the completion of group therapy sessions; The absence of more than two sessions of group therapy.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences, Research Vice- Chancellor
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
TBZMED.REC.1394.390
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
F31.7
ICD-10 code description
Bipolar affective disorder, currently in remission
Primary outcomes
1
Description
Cognitive emotion regulation strategies
Timepoint
Before intervention, one week and three months after finishing intervention
Method of measurement
Cognitive Emotion Regulation Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the pre-test will be done. Intervention group will receive 12 sessions group therapy. Then, the post-test and follow-up will be done. Finally, the differences of pre-test, post-test and follow-up are compared with each other.
Category
Prevention
2
Description
Control group: This group will not receive any intervention. The differences of pre-test, post-test and follow-up are measured and compared with each other.