Protocol summary
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Study aim
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Determine the effectiveness of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
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Design
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Practical and semi-experimental data collection is pre-test, post-test and follow up with control group. Clinical trial with control group, not blind, sample selection available targeted.
Experimental group was 14 and control group was 15
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Settings and conduct
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The treatment room of the Kurdistan University
Meetings weekly for one hour for each client
At each session, specific psychological techniques were practiced with clients at each session
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Participants/Inclusion and exclusion criteria
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The criteria for entering ، at least 18 years of age, male and female gender, diagnosis of anxiety disorder and depression. According to the psychiatrist, Sanandaj resident, No substance use, the willingness to participate and not receiving any therapeutic interventions, including psychological and Medication at least in the last year.
Exclusion criteria, the occurrence of other psychiatric disorders, one and two, except emotional disturbances, the risk of suicide.
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Intervention groups
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The experimental group received the transdiagnostic treatment with the drug, which included eight sessions of 50 to 60 minutes per week. The control group received only medication.
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Main outcome variables
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anxiety and depression.
General information
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Reason for update
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In the English title the name of the treatment was mistaken for the meta-cognitive meta-diagnosis.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181019041385N1
Registration date:
2019-10-28, 1398/08/06
Registration timing:
retrospective
Last update:
2020-01-12, 1398/10/22
Update count:
1
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Registration date
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2019-10-28, 1398/08/06
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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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2018-11-11, 1397/08/20
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Expected recruitment end date
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2019-03-11, 1397/12/20
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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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Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
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Public title
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Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Anxiety Disorder and Comorbid Depression (According to Psychiatrist)
Sanandaj resident
No history of substance abuse
The desire to participate and not receive any therapeutic intervention, including psychological and medication, at least in the last year
Exclusion criteria:
Has personality disorders
A history of suicide
illiterate
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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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:
29
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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Secondary Ids
1
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Registry name
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www.iranduc.ir
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Secondary trial Id
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1426565
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Registration date
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2018-05-21, 1397/02/31
Ethics committees
1
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Ethics committee
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Approval date
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2019-07-29, 1398/05/07
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Ethics committee reference number
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IR.UOK.REC.1398.023
Health conditions studied
1
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Description of health condition studied
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Anxiety disorders and complex depression
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ICD-10 code
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F41.3
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ICD-10 code description
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Anxiety disorders and complex depression
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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pre test, post test and follow up(one month after treatment)
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Method of measurement
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Beck Anxiety Inventory
2
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Description
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Depression
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Timepoint
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pre test, post test and follow up(one month after treatment)
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Method of measurement
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Beck Depression Inventory
Secondary outcomes
1
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Description
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emotional regulaition
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Timepoint
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Before and after 8 sessions of treatment
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Method of measurement
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Use the emotion regulation difficulty questionnaire
2
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Description
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Negative repetitive thoughts
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Timepoint
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Before and after 8 sessions of treatment
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Method of measurement
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Using Negative repetitive Thought Questionnaire
3
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Description
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Intolerance of Uncertainly
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Timepoint
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Before and after 8 sessions of treatment
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Method of measurement
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Use of uncertainty intolerance questionnaire
4
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Description
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Anxiety Sensitivity
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Timepoint
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Before and after 8 sessions of treatment
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Method of measurement
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Anxiety Sensitivity Questionnaire
5
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Description
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Experiential Avoidance
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Timepoint
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Before and after 8 sessions of treatment
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Method of measurement
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Experiential Avoidance Questionnaire
Intervention groups
1
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Description
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In the present study, participants were taking Anti-anxiety and antidepressant medication(Such as serotonin, Clonazepam, Buspirone, and venlafaxine) and also received eight sessions of transdiagnostic cognitive-behavioral therapy. Session 2: Psychological Training and Emotion Recognition. Session 3: Emotional Awareness Training.Session 4: Cognitive Assessment and Reassessment. Session 5: Emotional Avoidance (Behavior Understanding). Session 6: Emotional Behavior Behaviors (EDBs) Session 7: Exposure to Physical Sensations.
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Category
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Treatment - Other
2
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Description
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Control group: only anti-anxiety and anti-depressant drugs they consume.
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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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The university of kurdestan
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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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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
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Title and more details about the data/document
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The data will be provided after it is completed.
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When the data will become available and for how long
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Information will be provided up to 5 months after the defense.
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To whom data/document is available
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Under the guidance of the supervisor, information will be provided.
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Under which criteria data/document could be used
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For the scientific use and promotion of knowledge.
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From where data/document is obtainable
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From the Supervisor Dr. Mehdi zemestany.
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What processes are involved for a request to access data/document
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Information will be provided up to 5 months after the defense.
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Comments
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