Obsessive-Compulsive SymptomNCT04221841
Executive Functions and Reinforcement Sensitivity in Women With Obsessive Compulsive Symptoms
An observational study of Obsessive-Compulsive Symptom and Executive Dysfunction, run by Malahat Amani at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Symptom, Executive Dysfunction
- What is being tested?
- descriptive
- How many people
- 365 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2019to 22 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- having age between 18 to 54, be female, be literacy,
Who cannot join
- be male, be illiteracy, having psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: University of Bojnord
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.
- Being tested
- descriptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiveOther
correlation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Oct 2019
- Primary completion1 Nov 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malahat Amani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malahat Amani, University of Bojnord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221841
- Sponsor's protocol ID
- 131820
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Bojnord
- ClinicalTrials.gov ID
- NCT04221841
- Acronym / sponsor ID
- 131820
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Malahat AmaniUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- having age between 18 to 54, be female, be literacy,
Key exclusion criteria (1 listed)
- be male, be illiteracy, having psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| descriptivecorrelation | Other | – |
Primary outcome
executive functions
Time frame: 1 month
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.
obsessive-compulsive symptom
Time frame: 1 month
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.
reinforcement sensitivity
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Symptom and Executive Dysfunction, run by Malahat Amani at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
executive functions (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.