Protocol summary
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Study aim
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Determining the efficacy of acceptance and commitment therapy in improving psychological symptoms in patients with social anxiety disorder
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Design
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Clinical trial with control group, Not blinded, Randomized
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Settings and conduct
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This study is conducted at the counseling Center of Kermanshah University of Medical Sciences. Patients receive 12 sessions of acceptance and commitment therapy individually and weekly. The duration of each session is 90 minutes. To evaluate the follow up period again two months after the end of the intervention the subjects are evaluated. In order to evaluate the effects of treatment subjects will be evaluated one week before, one week after and two months after the end of the intervention respectively. The intervention is done by an experienced psychologist and based on Eifert and Forsyth protocol.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: having social anxiety disorder as the main diagnosis.
Exclusion criteria: current diagnosis of any comorbid mental disorders in axis 1 and 2 based on a psychiatrist's diagnostic interview.
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Intervention groups
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Intervention group: 12 people with social anxiety disorder will receive 12 sessions of treatment based on cceptance and commitment.
Control group: 12 people and do not receive any special treatment.
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Main outcome variables
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Social anxiety; Self-compassion; Acceptance and action; External shame; Difficulty in regulating excitement; Interpersonal sensitivity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180421039369N1
Registration date:
2018-09-16, 1397/06/25
Registration timing:
retrospective
Last update:
2020-05-02, 1399/02/13
Update count:
1
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Registration date
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2018-09-16, 1397/06/25
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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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2018-04-18, 1397/01/29
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Expected recruitment end date
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2018-05-19, 1397/02/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The efficacy of acceptance and commitment therapy in improving psychological symptoms in patients with social anxiety disorder
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Public title
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The assessment of acceptance and commitment therapy on social anxiety
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The main and primary diagnosis of social anxiety disorder based on anxiety disorder interview
Patient's agreement to participate in research
Lack of psychological therapy in the last year
No psychiatric medication intake during the past six months
No main and primary diagnosis of mood disorders and other anxiety disorders
Exclusion criteria:
Current diagnosis of any comorbid mental disorders in Axis 1 and 2 based on a psychiatrist's diagnostic interview
History of current substance dependence and over a year before the onset of treatment
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Age
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From 18 years old to 65 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:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For randomizing assignment, the Simple Random method is used. 24 cards with the same appearance are provided. On 12 of cards the number 1 and on 12 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.
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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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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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2018-05-21, 1397/02/31
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Ethics committee reference number
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IR.KUMS.REC.1397.085
Health conditions studied
1
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Description of health condition studied
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Social phobias
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ICD-10 code
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F40.1
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ICD-10 code description
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Social phobias
Primary outcomes
1
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Description
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Social phobia
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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Spin social anxiety questionnaire
Secondary outcomes
1
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Description
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External shame
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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External shame questionnaire
2
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Description
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Self-compassion
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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Self compassion questionnaire
3
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Description
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Acceptance and action
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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Acceptance and Action Questionnaire
4
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Description
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Difficult emotion regulation
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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Difficult emotion regulation scale
5
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Description
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Interpersonal sensitivity
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Timepoint
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A week before the intervention, one week after the intervention, two months after the intervention
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Method of measurement
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Interpersonal Sensitivity Questionnaire
Intervention groups
1
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Description
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Intervention group: the intervention group consists of 12 individuals during the 12 sessions receiving Treatment based on acceptance and commitment individually according to eifert and forsyth protocol. This treatment has two main objectives: 1) Enhancing the power of accepting unpleasant thoughts and feelings that the patient does not have control over their existence or disappearance. 2) Commitment and action towards the kind of life that is valuable to him. In this treatment the concepts of acceptance, commitment, values and exposure to anxiety are trained and treatment sessions are held weekly and each session lasts 90 minutes during three months. After that, the follow-up period takes two months.
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Category
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Behavior
2
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Description
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Control group: consists of 12 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive acceptance and commitment treatment for maintaining the ethics of the control group.
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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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Kermanshah University of Medical Sciences
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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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Kermanshah 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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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 more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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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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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available