Relationships of Executive Functions, Severity of Psychiatric Symptoms With Response to Therapy

• ClinicalTrials.gov Identifier: NCT04603170
• Recruitment Status: Completed
• First Posted: October 26, 2020
• Last Update Posted: October 28, 2020
• Sponsor: Malahat Amani
• Information provided by (Responsible Party): Malahat Amani, University of Bojnord

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Patient Acceptance of Health Care	Other: DRUG

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 Design

• Study Type: Observational
• Actual Enrollment: 164 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: University of Bojnord
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: February 1, 2019
• Actual Study Completion Date: March 1, 2019

Groups and Cohorts

Intervention Details:

• Other: DRUG
  taking drug medication prescribed by psychiatrists for at least one month

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes 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)

Criteria

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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Malahat Amani

Bojnourd, North Khorsan, Iran, Islamic Republic of

Sponsors and Collaborators

Malahat Amani

Investigators

• Principal Investigator: Malahat amani, ph.d; University of Bojnord

More Information

• Responsible Party: Malahat Amani, University of Bojnord
• ClinicalTrials.gov Identifier: NCT04603170
• Other Study ID Numbers: 13180899
• First Posted: October 26, 2020
• Last Update Posted: October 28, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No