NCT04603170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 20, 2020

Last Update Submit

October 26, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Outcome questionnaire

    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

    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

    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

Interventions

DRUGOTHER

taking drug medication prescribed by psychiatrists for at least one month

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • receiving a diagnosis of anxiety and depression disorders, age over 18 years, and taking drug medication prescribed by psychiatrists for at least one month.-

You may not qualify if:

  • having psychotic disorders, age under 18 years and absence from treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malahat Amani

Bojnourd, North Khorsan, Iran

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Malahat amani, ph.d

    University of Bojnord

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Malahat Amani

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

January 1, 2019

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations