NCT04221841

Brief Summary

Methods: The study population consisted of all adult women living in Sabzevar city (Iran). Using cluster sampling, 365 women were selected as the study sample. Participants completed Obsessive-Compulsive Inventory, Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Revised and Clarified (SPSRQ-RC) as well as Behavior Rating Inventory of Executive Function (BRIEF). Data analysis was conducted using correlation and regression tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 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

October 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

January 6, 2020

Last Update Submit

January 11, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • executive functions

    It was measured by behavior rating inventory of executive function. it consists of 75 items that are measured on a 5-point Likert scale. subscales include inhibition, shift, emotional control, self-monitoring, initiation, working memory, planning/organization, task monitoring and organization of materials. min and max scores are 0 and 150. respectively. the higher scores indicate problems in executive functions.

    1 month

  • obsessive-compulsive symptom

    it was measured by the Obsessive-Compulsive Inventory. This inventory contains 42 items that are measured on a 5-point Likert scale. It consists of the sub-scales of washing, controlling, doubting, ordering, obsession, hoarding, and neutralizing. the higher scores are probably an indicator of obsessive-compulsive disorder.

    1 month

  • reinforcement sensitivity

    it was measured by Sensitivity to Punishment and Sensitivity to Reward Questionnaire: This 20-item scale measures sensitivity to reward and sensitivity to punishment, which is scored on a 5-point Likert scale (from "totally correct" to "totally incorrect"). the higher scores in subscales of sensitivity to punishment and Sensitivity to Reward indicate high activity in punishment and reward systems.

    1 month

Interventions

correlation

Eligibility Criteria

Age18 Years - 54 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The statistical population consisted of all adult women living in Sabzevar city in 2019. The sampling was conducted using cluster sampling method. In randomly selected areas, participants were selected from among local women

You may qualify if:

  • having age between 18 to 54, be female, be literacy,

You may not qualify if:

  • be male, be illiteracy, having psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malahat Amani

Bojnourd, North Khorasan, 9453155111, Iran

Location

Study Design

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

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

October 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 22, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations