Comparison of the effectiveness of behavioral-cognitive therapy Beck based model and well-being therapy on clinical signs and life satisfaction in patients with major depression
The aim of this study is the comparison of the effectiveness of behavioral-cognitive therapy beck based model and well-being therapy on clinical signs and life satisfaction in patients with major depression
Design
This is a clinical trial with the control group, community-based and pragmatic. 36 individuals with major depression randomly will be assigned to three groups.
Settings and conduct
The participant’s evaluation in the first and second intervention groups will be conducted by beck depression inventory and Rife Psychological Well-being Questionnaires respectively. In intervention groups during each session, the pre-test and post-test will be conducted and re-examined two months later. However, in control group tests will be conducted during the course like intervention groups. This study will conduct at the Shamim Psychological Center in Bojnourd.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from a depression score of over 19 based on Beck Depression Test, having at least a diploma, having a minimum age of 18 and a maximum age of 50, Exclusion criteria:Suffering from major mental disorders such as personality disorder, drug and alcohol addiction, Getting other psychological and pharmaceutical treatments simultaneously with research
Intervention groups
Training in the intervention cognitive-behavioral group is done in twelve ninety-minute sessions and twice a week and also training in the welfare intervention group is done in eight fifty-minute sessions and once a week. There will be no training in the control group.
Main outcome variables
Clinical Signs, Life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181016041364N1
Registration date:2018-11-29, 1397/09/08
Registration timing:registered_while_recruiting
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Hassan Sarabandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 9017
Email address
sarabandih@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of behavioral-cognitive therapy Beck based model and well-being therapy on clinical signs and life satisfaction in patients with major depression
Public title
Comparison of the effectiveness of two educational methods on major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from a depression score higher than 19 in the Beck depression test
Having at least a diploma degree
Having at least 18 years of age and up to 50 years’ old
Exclusion criteria:
Suffering from major mental disorders such as personality disorder, drug and alcohol addiction
Getting other psychological and pharmaceutical treatments simultaneously with research
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
36 individuals will be randomly assigned to three groups. Block randomization based on permutation. Accordingly, 12 blocks will be allocated to patients, in each block 3 from intervention group 1, 3 from the intervention group 2, and 3 from the control group will be placed. Eventually, after completion of the blocks, group 1 will be trained by cognitive-behavioral therapy based on Beck's pattern and Group 2 train with welfare setting, and control group does not receive any treatment
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 Neyshabur
Street address
Ethics committee, Complex of Islamic Azad University of Neyshabur, Pazhouhesh Street, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319797139
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1397.008
Health conditions studied
1
Description of health condition studied
Major depression signs
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, After intervention and Two months after the first intervention
Method of measurement
Beck depression questionnaire
2
Description
Life satisfaction
Timepoint
Before intervention, After intervention and Two months after the first intervention
Method of measurement
Multidimensional life satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Beck-based cognitive-behavioral therapy will be conducted in twelve nine-minute sessions and twice a week. during each session, pre-test and post-test will be conducted by beck depression inventory and re-examined two months later. in each session, specific goals are examined, but the whole structure of treatment during the sessions includes assessment, introducing treatment to the patient and familiarity with the logic of treatment, applying cognitive-behavioral techniques and interventions, prevention of recurring and treatment follow-up. Meetings will also be conducted by a trained therapist.
Category
Behavior
2
Description
Intervention group 2: Wellness therapy will be carried out in eight fifty-minute sessions and once a week. during each session, the pre-test and post-test will be conducted by Rifa Psychological Well-being Questionnaire and re-examined two months later. in each session, specific goals are examined, but the whole structure of treatment during the sessions include assessment, introducing treatment to the patient and familiarity with the logic of treatment, applying cognitive-behavioral techniques and interventions, prevention of recurring and treatment follow-up. Meetings will also be conducted by a trained therapist.
Category
Behavior
3
Description
Control group: This group does not receive any treatment. However, tests will be conducted during the course like intervention groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shamim Consulting Center, Bojnourd County
Full name of responsible person
Hassan Sarabandi
Street address
Shamim Consulting Center, Jawad Alaeman Clinic, Government Boulevard, Bojnourd
City
Bojnourd
Province
North Khorasan
Postal code
9419694657
Phone
+98 58 3240 2022
Email
sarabandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Najat
Street address
General gsychology group, Islamic Azad University, Neyshabur, Iran
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319797139
Phone
+98 51 4262 1901
Email
hnejat54@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hassan Sarabandi
Position
Ph.D. student of Public Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shaghayeg Ave, Vakil Abad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179673983
Phone
+98 51 3864 3711
Email
sarabandih@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Sarabandi
Position
PhD student in public psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shaghayeg Ave, Vakil Abad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9319797139
Phone
+98 51 3864 3711
Email
sarabandih@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Sarabandi
Position
PhD student in public psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shaghayeg Ave, Vakil Abad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9319797139
Phone
+98 51 3864 3711
Email
sarabandih@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
Not applicable
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