- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603170
Relationships of Executive Functions, Severity of Psychiatric Symptoms With Response to Therapy
October 26, 2020 updated by: Malahat Amani
University of Bojnord
This study was conducted to investigate the moderating role of executive functions in the relationship between the severity of psychiatric symptoms and response to therapy.
The statistical population of this study was all outpatients with anxiety disorders and depression who referred to psychiatric clinics.
Study Overview
Detailed Description
This study was conducted to investigate the moderating role of executive functions in the relationship between the severity of psychiatric symptoms and response to drug therapy in depressed and anxious patients.
The statistical population of this study was all outpatients with anxiety disorders and depression who referred to psychiatric clinics.
164 participants completed Outcome Questionnaire, Brief Symptom Inventory, and Behavior Rating Inventory of Executive Function (BRIEF).
Study Type
Observational
Enrollment (Actual)
164
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Khorsan
-
Bojnourd, North Khorsan, Iran, Islamic Republic of
- Malahat Amani
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The statistical population included all adult outpatients with anxiety and depression disorders who referred to psychiatric offices in Bojnord city Sample was selected among the clients of psychiatric offices who received the diagnosis of anxiety and depression disorders and volunteer to participate in the study were sample (n=164)
Description
Inclusion Criteria:
receiving a diagnosis of anxiety and depression disorders, age over 18 years, and taking drug medication prescribed by psychiatrists for at least one month.-
Exclusion Criteria:
- having psychotic disorders, age under 18 years and absence from treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Outcome questionnaire
Time Frame: ONE WEEK
|
This questionnaire was designed to assess response to treatment.
This questionnaire has the dimension of mental distress or signs of distress, interpersonal relationships, and social role.
This 45-item questionnaire is answered on a 5-point Likert scale ranging 0 to 4 (not at all to extremely).Scores range from 0 to180.
higher scores mean a worse outcome.
|
ONE WEEK
|
Brief Symptom Inventory
Time Frame: ONE WEEK
|
This inventory measures the symptoms of psycho-somatization, obsessive-compulsive, interpersonal sensitivity, paranoid thoughts, depression, psychosis, general anxiety, hostility and anxiety.
It was answered to questions based on the 5-point Likert scale ranging from 0 to 4 (not at all to perfectly).
This questionnaire is 53 items.
Scores range from 0 to 212.range of score are higher scores mean a worse outcome and mental health problems.
|
ONE WEEK
|
Behavior Rating Inventory of Executive Function
Time Frame: ONE WEEK
|
This questionnaire is used to measure the executive functions of adults aged 18 to 90 from their daily performance in the natural environment.
It has 75 items that measure factors including response inhibition, shifting, emotional control, self-monitoring, initiation, working memory, planning, material organization, and task monitoring.
It was answered to questions based on the 3-point Likert scale ranging from 0 to 2 (not at all to extremely). the scores range 0 to 150.
High score is indicator of weak executive functions.
|
ONE WEEK
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Malahat amani, ph.d, University of Bojnord
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
October 20, 2020
First Submitted That Met QC Criteria
October 20, 2020
First Posted (Actual)
October 26, 2020
Study Record Updates
Last Update Posted (Actual)
October 28, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 13180899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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