Protocol summary
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Study aim
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Investigating the effectiveness of combined schema therapy and dialectical behavior therapy for obsessive-compulsive disorder
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Design
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60 people with obsessive-compulsive disorder were selected by purposive sampling and then randomly divided into three experimental groups of 15 people and a control group of 15 people.
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Settings and conduct
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Farad, all four groups in the psychiatric office first filled the dysfunctional attitudes and mental health questionnaire as a pre-test, then all three intervention groups received treatments and the control group did not receive treatment. The test was taken from the subjects.
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Participants/Inclusion and exclusion criteria
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Entry criteria: suffering from obsessive-compulsive disorder, over 18 years of age, at least a high school diploma.
Non-entry criteria: suffering from one and two mental disorders other than obsessive-compulsive disorder, currently or in the last six months, involvement with trauma, drug and alcohol abuse, taking psychiatric drugs
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Intervention groups
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There are three intervention groups: the first group receives only dialectical behavior therapy. The second group receives only schema therapy. The third group receives first dialectical behavior therapy and then schema therapy.
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Main outcome variables
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Dysfunctional attitudes, Mental health, Symptoms of obsessive-compulsive disorder
General information
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Reason for update
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Complete the entered information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240517061824N1
Registration date:
2024-06-01, 1403/03/12
Registration timing:
retrospective
Last update:
2024-11-24, 1403/09/04
Update count:
2
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Registration date
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2024-06-01, 1403/03/12
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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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2023-07-23, 1402/05/01
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Expected recruitment end date
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2024-06-19, 1403/03/30
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Actual recruitment start date
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2023-04-21, 1402/02/01
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Actual recruitment end date
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2023-07-23, 1402/05/01
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Trial completion date
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2024-02-09, 1402/11/20
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Scientific title
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Comparing the effectiveness of dialectical behavior therapy, schema therapy and the Combination of both therapies on dysfunctional attitudes, mental health and symptoms of people with obsessive-compulsive disorder
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Public title
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Comparing the effectiveness of dialectical behavior therapy, schema therapy and the Combination of both therapies on dysfunctional attitudes, mental health and symptoms of people with obsessive-compulsive disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Suffering from obsessive-compulsive disorder
Education at least diploma
Age over 18 years
Not suffering from personality disorders
Absence of trauma at present or in the past 6 months
Consent to participate in rese
Exclusion criteria:
Abuse of drugs or alcohol
Taking psychiatric medication
Suicidal thoughts
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Age
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From 18 years old to 50 years old
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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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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: simple
Randomization Unit: Individual
Among the people referred to the psychiatric office, 60 people who were diagnosed with obsessive-compulsive disorder by clinical interview and the Yale-Brown Obsession Questionnaire were selected, then they were randomly assigned to three experimental groups and one control group, as follows. A lottery was held and each person took the papers in which one of the behavioral therapy, schema therapy, combined and control groups were written from inside the box and belonged to that group, and this was done until the completion of each group, which was 15 people. .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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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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2024-05-27, 1403/03/07
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Ethics committee reference number
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IR.MUBABOL.REC.1403.012
Health conditions studied
1
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Description of health condition studied
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Obsessive-compulsive disorder
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ICD-10 code
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F42
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ICD-10 code description
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Obsessive-compulsive disorder
Primary outcomes
1
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Description
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Dysfunctional Attitudes
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Timepoint
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Before the start of the therapy and immediately after the end of the therapy
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Method of measurement
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DAS Dysfunctional Attitudes Questionnaire
2
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Description
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Mental Health
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Timepoint
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Before the start of the therapy and immediately after the end of the therapy
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Method of measurement
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Goldberg General Health Questionnaire-28
3
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Description
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Symptoms of obsessive-compulsive disorder
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Timepoint
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Before the start of the therapy and immediately after the end of the therapy
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Method of measurement
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Yale Brown Obsessive-Compulsive Questionnaire
Intervention groups
1
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Description
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Intervention group 1: Dialectical behavior therapy
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Category
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Treatment - Other
2
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Description
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Intervention group 1: Dialectical behavior therapy
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Category
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Treatment - Other
3
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Description
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Intervention group 3: combined therapy (schema therapy with dialectical behavior therapy)
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Category
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Treatment - Other
4
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Description
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Control group: did not receive any treatment
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Category
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Treatment - Other
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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ARYAN Institute of Science and Technology
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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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Private
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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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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Not applicable
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Informed Consent Form
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No - There is not 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A part of the study data, which includes the results of the effectiveness of the treatments, is shared through the articles extracted from the thesis
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When the data will become available and for how long
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Access started immediately after the articles were published in 1403
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To whom data/document is available
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Study data will be available to all people
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Under which criteria data/document could be used
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No decision has been made on this yet
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From where data/document is obtainable
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No decision has been made on this yet
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What processes are involved for a request to access data/document
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No decision has been made on this yet
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Comments
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