Protocol summary
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Study aim
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The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
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Design
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This double-blind controlled clinical trial has an intervention group and a control group. The participants were screened in two stages, first, they were evaluated using BDI-II, those who scored 14 and highest were invited to interview (n=96). Then participants based on inputs and outputs and diagnosis of Major Depressive Disorder (n=40) were assigned to two groups with the Random number generator V 1.3 (n=20). Finally, the interventions were done and after the interventions and assessments, the information was analyzed by SPSS (n=36).
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Settings and conduct
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After a diagnostic interview by a psychiatrist, patients who are diagnosed with major depressive disorder are randomly assigned to intervention and control groups, also assessment will done in two months after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Being university student
2. Residence in Zanjan while researching
3. Tending to participate in research
4. Scores between 14 - 25 in beck depression inventory second edition and major depressive disorder diagnosis by the psychiatrist.
Exclusion criteria:
1. Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders
2. Depression related to medical condition
3. Previous psychological intervention specially cognitive behavioral therapy more than five sessions
4. Consume psychotropic drugs
5. The history of hospitalization and receiving electroconvulsive therapy (ECT)
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Intervention groups
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Intervention group will receive behavioral activation group therapy; and control group will receive only behavioral activation booklet.
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Main outcome variables
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Depression severity, repetitive thoughts and educational social function
General information
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Reason for update
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During the research process, modifications were implemented based on existing limitations and opportunities. The key changes include:
1. As the number of patients with a diagnosis interval exceeded expectations and enlarging the sample size had no impact on the research process, a consultation with the scientific research team, including the supervisor, led to an increase in the sample size to 40 individuals.
2. Considering the university's limitation on academic years, the follow-up period was shortened from 6 months to 2 months in collaboration with the department director and supervisor.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181128041782N1
Registration date:
2019-03-04, 1397/12/13
Registration timing:
registered_while_recruiting
Last update:
2023-12-20, 1402/09/29
Update count:
1
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Registration date
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2019-03-04, 1397/12/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-21, 1397/11/01
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Expected recruitment end date
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2019-03-20, 1397/12/29
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Actual recruitment start date
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2019-01-21, 1397/11/01
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Actual recruitment end date
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2019-03-20, 1397/12/29
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Trial completion date
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2019-07-14, 1398/04/23
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Scientific title
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The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial
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Public title
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The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being university student
Residence in Zanjan while researching
Tending to participate in research
Scores between 14 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist
Exclusion criteria:
Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders
Depression related to medical condition
Previous psychological intervention specially cognitive behavioral therapy more than five sessions
Consume psychotropic drugs
The history of hospitalization and receiving electroconvulsive therapy (ECT)
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
32
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After diagnosis by the psychiatrist, a list of patients with inclusion criteria is prepared and numbered and assigned to treatment and control groups by Random number generator V 1.3 software; so that all participants have equal chance of being in the groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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After sampling, any of participant will not aware from randomization and allocation to groups. The data analyzer is selected outside of the study and all of datas will be given to him as a code.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-27, 1397/09/06
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Ethics committee reference number
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IR.ZUMS.REC.1397.255
Health conditions studied
1
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Description of health condition studied
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Major Depressive Disorder - Mild
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ICD-10 code
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F32.0
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ICD-10 code description
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Major depressive disorder, single episode, mild
2
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Description of health condition studied
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Major Depressive Disorder - Moderate
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ICD-10 code
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F32.1
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ICD-10 code description
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Major depressive disorder, single episode, moderate
Primary outcomes
1
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Description
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Depression Severity
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Timepoint
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Pre-test, Post-test and follow up (Two months after post-test)
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Method of measurement
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Beck Depression Inventory-II (BDI-II)
Secondary outcomes
1
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Description
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Repetitive thoughts
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Timepoint
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Pre-test, Post-test and Follow up (Two months after post- test)
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Method of measurement
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Repetitive Thinking Questionnaire-31
2
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Description
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Function of students
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Timepoint
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Pre-test, Post-test and Follow up (Two months after post- test)
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Method of measurement
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Work (Educational) and Social Adjustment Scale
Intervention groups
1
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Description
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Intervention group will receive ten session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.
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Category
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Behavior
2
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Description
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Control group will receive only behavioral activation booklet، which contains the same topics with the intervention group and will be checked weekly by internet and and guidance will be provide if needed.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All of the information related to main outcome will be published.
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When the data will become available and for how long
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Start the access period from 2023
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Access to documents is possible to inform other researchers. Access to documents is possible to work with the researcher.
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From where data/document is obtainable
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1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed
2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi
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What processes are involved for a request to access data/document
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Documents will be shared only when the reason for the request is announced by phone or e-mail.
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Comments
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Researchers can contact S.saberipsy@gmail.com to access the results and details.