Comparison of the effect of cognitive-behavioral therapy and treatment based on acceptance and commitment on family functioning, care burden, quality of life, experiential avoidance, anxiety, depression and stress in informal caregiver patients with traumatic brain injury.
Comparison of the Effect of Cognitive-Behavioral Therapy and Acceptance and Commitment-Based Therapy on Family Emotional and Behavioral Factors and unofficial Caregivers of Patients with Brain Injury
Design
The clinical trial has two groups of intervention and one control group, with parallel groups, randomized
Settings and conduct
Sixty people who are caring for an individual who are diagnosed with brain damage will be selected on a non-target based sampling basis. Demographic information is collected through interviews and questionnaires and then they will be controlled. The random allocation of individuals in the intervention and control groups will be done in random blocks and then will be aggregated. Then in an intervention group, an ACT group and a CBT group will be treated. After the end, follow up courses that will be completed 2 months and 4 months after the treatment will be completed, so that the questionnaires will be administered to both groups,
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having a family member with a diagnosis of traumatic brain damage
2- Have minimum cycle education
3- Care for at least 3 consecutive months
4. Conscientiousness
5. Not having a history of physical illness and severe mental illness before engaging in research.
6- Individuals aged 25-50 years
Exclusion criteria:
1. More than two absentee sessions in the treatment of CBT
2. More than one absentee session in ACT treatment
3. Acute or chronic mental or physical illness after engaging in research
4. Need for medication or other therapies
Intervention groups
An intervention group is undergoing cognitive-behavioral therapy, and the other intervention group receiving treatment based on acceptance and commitment
Main outcome variables
Changes in healthcare policy and management; treatment costs; quality of diagnosis and treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190704044100N1
Registration date:2020-09-03, 1399/06/13
Registration timing:retrospective
Last update:2020-09-03, 1399/06/13
Update count:0
Registration date
2020-09-03, 1399/06/13
Registrant information
Name
mahtab hadavand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 8432 3338
Email address
mahtab.hadavand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cognitive-behavioral therapy and treatment based on acceptance and commitment on family functioning, care burden, quality of life, experiential avoidance, anxiety, depression and stress in informal caregiver patients with traumatic brain injury.
Public title
Comparison of the Effect of Cognitive-Behavioral Therapy and Acceptance and Commitment-Based Therapy on Caregivers of Patients with Brain Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a family member with a diagnosis of traumatic brain damage
Have minimum cycle education
Care for at least 3 consecutive months
Informed consent
Not having a history of physical illness (cancer, MS) and severe psychosis (types of psychotic disorders) before engaging in research
People aged 25-50 years
Exclusion criteria:
More than two absentee sessions in the treatment of CBT
More than one absentee session in ACT treatment
Acute or chronic mental or physical illness after engaging in research
Need for medication or other therapies
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of individuals in intervention and control groups is done in random blocks . The randomization unit will be done individually by the table of random numbers.
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 kashan University of Medical Sciences
Street address
Kashan, Roubandi Boulevard,Kashan University of Medical Sciences and Health Services
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.076
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Depression score, anxiety and stress in the DASS21 questionnaire
Timepoint
Measurement of depression, anxiety, stress at the beginning of the study, end of study, 2 months after the end of the study, 4 months after the end of the study
Method of measurement
DASS21 questionnaire
Secondary outcomes
1
Description
The score that a person earns in quality of life questionnaires(SF-36).
Timepoint
Before the intervention, the end of the intervention, 2 months after the intervention, 4 months after the intervention
Method of measurement
SF-36
Intervention groups
1
Description
Intervention group: cognitive behavioral therapy
Category
Treatment - Other
2
Description
Intervention group: Acceptance and commitment therapy
Kashan, km 5 Ravand road, Ravandi boulevard, Shahid Beheshti Hospital
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Email
mahtab.hadavand@yahoo.com
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
Mahtab Hadavand
Position
Master of Science in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
mahtab.hadavand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Hadavand
Position
Master of Science in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan, Ravandi Boulevard, Kashan University of Medical Sciences, medical School
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
mahtab.hadavand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Hadavand
Position
Master of Science in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
mahtab.hadavand@yahoo.comm
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data can be shared after unidentifiable people.
When the data will become available and for how long
Data will be available approximately 4-6 months after data interruptions.
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
At the request of the applicant is in line with the objectives of the study, it promotes the development of prevention and treatment, promotes research in the field of study.
From where data/document is obtainable
09037671285
mahtab.hadavand@yahoo.com
What processes are involved for a request to access data/document
About 4-6 months after the data interruption is available. The applicant is only required to send a request to the contact number and email. After examining the application, it will be emailed about one to two weeks if the request is in line with the intended purpose.