Comparison of the effects of cognitive behavioral therapy and acceptance and commitment therapy on cognitive flexibility, executive function, anxiety, depression, and quality of life of patient and caregiver in patients with major depressive disorder after traumatic brain injury
Determining the effect of two cognitive-behavioral therapeutic approach and an acceptance and commitment-based therapy model on psychological flexibility, executive functions, depression, anxiety, quality of life associated with health related to patient and caregiver in patients with major depression after traumatic brain injury
Design
A clinical trial with a control group, sample size 60 people, with parallel groups of three groups of 20 people, single blind, randomized by random numbers table.
Settings and conduct
Trauma Research Center of Kashan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Having MDD diagnosis after TBI means having P-TBI-MDD diagnosis
Intervention groups
Cognitive-behavioral group therapy (CBT): A treatment that will be done according to the 12-hour protocol that has been adapted from Bieling et all
Acceptance and Commitment Therapy Model (ACT): An intervention that will be implemented according to the protocol of 12 sessions proposed by Robert D. Zettle
Control group: No therapies will be received and members will discuss their problems in several sessions
Main outcome variables
Psychological flexibility; executive functions; Patient's anxiety and depression and quality of life; caregiver's anxiety and depression and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190115042371N1
Registration date:2019-02-19, 1397/11/30
Registration timing:retrospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Ali Faghihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3820 0772
Email address
faghihi-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-27, 1397/07/05
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-27, 1397/07/05
Actual recruitment end date
2018-12-18, 1397/09/27
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Comparison of the effects of cognitive behavioral therapy and acceptance and commitment therapy on cognitive flexibility, executive function, anxiety, depression, and quality of life of patient and caregiver in patients with major depressive disorder after traumatic brain injury
Public title
Comparison of the effects of cognitive behavioral therapy and acceptance and commitment therapy in major depressive disorder after traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having MDD diagnosis after TBI means having a P-TBI-MDD diagnosis
Duration of TBI between one and four years
informed consent
Ages 18 to 45 years
Have at least 8 years of education
Lack of alcohol, substance, or drugs abuse
Not having dementia and delirium and mental disorders other than major depression
Exclusion criteria:
Dissuading from participating in research
Abuse of alcohol, substance, or drugs after engaging in research
Having a disease or problems affecting function and mental health after engaging in research
Get absent in more than 2 sessions
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The list of patients suffering from brain injury was given to us through the medical records unit. Then all these people were coded. Subsequently, with the help of a random number table, sixty of these people are selected and then in the same way, they are divided into three groups (n=20).
Blinding (investigator's opinion)
Single blinded
Blinding description
Each group visits the hospital for treatment at different hours of the day, while the identity of the individuals in each group is hidden for other groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kashan University of Medical Sciences
Street address
Ethics Committee of Kashan University of Medical Sciences, Ghotb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
3713979671
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.024
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S00-S09
ICD-10 code description
Injuries to the head
2
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Psychological flexibility
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Acceptance and Action Questionnaire - II (AAQ-II)
2
Description
Executive functions
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Wisconsin Card Sorting Test and Tower of London test
3
Description
Anxiety
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Beck Anxiety Inventory, and Depression Anxiety and Stress Scales 21
4
Description
Depression
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Beck Depression Inventory-II, and Depression Anxiety and Stress Scales 21
5
Description
Quality of Life
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Quality of Life after Brain Injury
Secondary outcomes
1
Description
Problem solving
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Wisconsin Card Sorting Test
2
Description
Planning
Timepoint
Before the intervention, in the middle of intervention, after intervention, three months after the intervention
Method of measurement
Tower of London test
3
Description
Caregiver anxiety
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Depression Anxiety and Stress Scales 21
4
Description
Caregiver depression
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Depression Anxiety and Stress Scales 21
5
Description
Caregiver quality of life
Timepoint
Before the intervention, after intervention, three months after the intervention
Method of measurement
Short Form Health Survey (SF-12)
Intervention groups
1
Description
Intervention group 1: Cognitive-behavioral group therapy (CBT). A treatment that will be done according to the 14-sessions protocol that has been adapted from Bieling et all
Category
Behavior
2
Description
Intervention group 2: Acceptance and Commitment Therapy model (ACT). An intervention that will be implemented according to the protocol of 12 sessions proposed by Robert D. Zettle
Category
Behavior
3
Description
Control group: No therapies will be received and members will discuss their problems in several sessions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Trauma Research Center, Kashan University of Medical Sciences
Full name of responsible person
Dr. Esmaeil Fakharian
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences, Kashan, Isfahan, Iran
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
trc@kaums.ac.ir
Web page address
http://trc.kaums.ac.ir/default.asp
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafshe
Street address
Ghotb Ravandi Boulevard, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 0021
Email
medicine@kaums.ac.ir
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Faghihi
Position
clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
alifaghihi180@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Faghihi
Position
clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
alifaghihi180@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Faghihi
Position
clinical psychology master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0634
Email
alifaghihi180@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available