Protocol summary
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Study aim
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Assessment The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
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Design
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The clinical trial has a control group and an intervention group, without blinding, randomized on 32 participants. For randomization the site www.randomization.com will be used.
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Settings and conduct
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Psychological capital training in Ibn Sina Hospital of Mashhad will be conducted in 10 face-to-face sessions for 90 minutes and once a week on the intervention group. The control group will not receive the intervention. None of the participants know which of the control and intervention groups they are in.
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Participants/Inclusion and exclusion criteria
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Living in Mashhad
No psychiatric drug use
Not suffering from Psychological disorders
Not getting Psychological therapies in last year
No suicide history
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Intervention groups
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The intervention group (15 people) will attend the meetings at the specified time and hour. Psychological capital training will be conducted in 10 90-minute sessions, one session per week at Ibn Sina Hospital, and will be conducted by a master's student in clinical psychology under the supervision of the supervisor and with the supervision of the sessions.
The control group (15 people) will not receive a placebo. After filling the demographic information, psychological flexibility and distress tolerance questionnaires, the control group will not receive any intervention until the end of the research. According to the research ethics, after the end of the research and data analysis, psychological capital training will be implemented for the control group.
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Main outcome variables
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Distress Tolerance
Dimensions of Psychological Flexibility and
Anxiety, Stress and Depression Symptoms
General information
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Reason for update
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Failure to complete the sample within the desired period of time
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230820059198N1
Registration date:
2023-08-23, 1402/06/01
Registration timing:
prospective
Last update:
2024-02-05, 1402/11/16
Update count:
1
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Registration date
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2023-08-23, 1402/06/01
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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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2024-02-04, 1402/11/15
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Expected recruitment end date
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2024-02-29, 1402/12/10
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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 Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
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Public title
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The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Living in Mashhad
Informed consent to participate in research
Exclusion criteria:
Suffering from Psychological disorders
Taking psychiatric drugs
Receiving psychological treatments in the last year
A history of suicide attempts
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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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No information
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Sample size
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Target sample size:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random numbers table using www.randomization.com
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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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2023-08-08, 1402/05/17
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1402.245
Health conditions studied
1
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Description of health condition studied
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Anxiety, Stress and Depression Symptoms, Distress Tolerance, Psychological Flexibility
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ICD-10 code
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F41.2
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ICD-10 code description
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Mixed anxiety and depressive disorder
Primary outcomes
1
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Description
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Distress Tolerance score on Distress Tolerance Scale (DTS)
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Timepoint
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Pre intervention, Post intervention, 1 month after intervention
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Method of measurement
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Distress Tolerance Scale (DTS)
2
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Description
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Psychological Flexibility score on Psychological Flexibility Dimensions Questionnaire
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Timepoint
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Pre intervention, Post intervention, 1 month after intervention
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Method of measurement
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Psychological Flexibility Dimensions Questionnaire
3
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Description
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Score on Anxiety, Stress and Depression Scale (DASS-21)
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Timepoint
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Pre intervention, Post intervention, 1 month after intervention
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Method of measurement
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Anxiety, Stress and Depression Scale (DASS-21)
Intervention groups
1
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Description
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Intervention group: The intervention group (16 people) will attend the meetings at the specified time and hour. Psychological capital training will be conducted in 10 90-minute sessions, one session per week at Ibn Sina Hospital, and will be conducted by a master's student in clinical psychology under the supervision of the supervisor and with the supervision of the sessions.
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Category
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Other
2
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Description
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Control group: The control group (15 people) will not receive a placebo. After filling the demographic information, psychological flexibility and distress tolerance questionnaires, the control group will not receive any intervention until the end of the research. According to the research ethics, after the end of the research and data analysis, psychological capital training will be implemented for the control group.
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Category
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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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Mashhad 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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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