Protocol summary
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Study aim
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Comparison of the Effectiveness of unified protocol for adolescents (UP_A) with Music Therapy and mindfulness as an adjunct treatment of UP_A in Improving Psychological Symptoms in adolescents with emotional disorders.
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Design
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Randomized, with a sample size of 90, a clinical trial with a control group.
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Settings and conduct
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This treatment consists of three groups (two intervention groups and one control group). One group receives UP-A treatment with mindfulness , Another group receives UP-A with music therapy, and the control group that receives only UP-A treatment. This treatment is grouped and each group consists of 30 people. Mindfulness therapy is based on the self-help book "Sitting Like a Frog". The music content is basically a child's music that is selected after consultation with a number of musicians and psychologist. This study is without blindness. Treatment is done at Farabi Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: adolescents with emotional disorders; In the age range of eleven to sixteen years;
Exclusion criteria: Lack of medication during intervention; Not attending all treatment sessions
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Intervention groups
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Patients are randomly divided into two experimental groups and one control group, and the treatment program will be provided to experimental groups for 15 sessions, and the control group will receive only UP_A treatment. one of the experimental groups UP_A plus mindfulness and another group UP_A plus music therapy received.
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Main outcome variables
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Anxiety, depression, stress.
General information
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Reason for update
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Because the control group did not receive treatment, to follow the moral principles, it was decided that this group would also receive treatment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180205038630N2
Registration date:
2018-07-24, 1397/05/02
Registration timing:
registered_while_recruiting
Last update:
2020-04-28, 1399/02/09
Update count:
1
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Registration date
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2018-07-24, 1397/05/02
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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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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Comparison of the Effectiveness of unified protocol adolescents (UP_A) with music therapy and mindfulness as an adjunct treatment of UP_A in Improving Psychological Symptoms in adolescents with emotional disorders.
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Public title
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Comparison of the Effectiveness of UP_A with music therapy and mindfulness as an adjunct treatment of UP_A
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Students with emotional disorders
The age range is 11-16 years
Exclusion criteria:
Receiving the medication during the intervention
Lack of participation in all treatment sessions
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Age
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From 11 years old to 16 days 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:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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By simple random method individuals are assigned to the control and test groups using sealed envelope
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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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2018-06-20, 1397/03/30
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Ethics committee reference number
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IR.KUMS.REC.1397.178
Health conditions studied
1
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Description of health condition studied
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Attention deficit-hyperactivity disorder
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ICD-10 code
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F90
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ICD-10 code description
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Attention-deficit hyperactivity disorders
2
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Description of health condition studied
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Social anxiety disorder of childhood
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ICD-10 code
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F93.2
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ICD-10 code description
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Social anxiety disorder of childhood
3
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Description of health condition studied
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Phobic anxiety disorder of childhood
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ICD-10 code
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F93.1
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ICD-10 code description
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Phobic anxiety disorder of childhood
4
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Description of health condition studied
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Unsocialized conduct disorder
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ICD-10 code
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F91.1
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ICD-10 code description
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Unsocialized conduct disorder
Primary outcomes
1
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Description
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Score in the Aggression Questionnaire
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Bass & perry the aggression Questionnaire
2
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Description
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Score in the teenage inventory of social skills
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Inderbitzen &, foster The teenage inventory of social skills
3
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Description
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Depression score in depression, anxiety, stress scale
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Depression, anxiety, stress scale (DASS)
4
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Description
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Anxiety score in depression, anxiety, stress scale
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Depression, anxiety, stress scale (DASS)
5
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Description
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Stress score in depression, anxiety, stress scale
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Depression, anxiety, stress scale (DASS)
6
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Description
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Score in Clinician global impression-severity scale
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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Clinician global impression-severity scale (CGI-S)
7
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Description
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Score in the screen for child anxiety related emotional Disorders (SCARED)
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Timepoint
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At the beginning of the study, after the end of the intervention and two months after the study
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Method of measurement
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screen for child anxiety related emotional Disorders (SCARED)
Intervention groups
1
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Description
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First intervention group: For fifteen weeks receives unified protocol adolescents (UP-A) plus mindfulness.
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Category
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Behavior
2
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Description
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Second intervention group: For fifteen weeks receives unified protocol adolescents (UP-A) plus music therapy
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Category
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Behavior
3
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Description
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Control group: it only receives UP_A treatment
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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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No
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available