The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome

December 5, 2019 updated by: Kirstyn L. Krause
Whether used alone or in combination with other approaches, strategies such as cognitive restructuring (CR) and exposure are well-established treatments for anxiety. CR involves identifying and challenging thoughts, beliefs, or assumptions that maintain anxiety, and exposure involves confronting feared situations, typically in a gradual manner. Many theories have been proposed to explain why exposure is effective. One theory posits that corrective learning occurs only when expectations about the outcome of a situation are violated. Therefore, exposure is thought to be effective when the discrepancy between the expected and actual outcome is maximized. One group of researches has suggested that engaging in CR prior to exposure will prematurely reduce the discrepancy between expectancy and outcome, resulting in less inhibitory learning. As such, they recommend that CR only be conducted after exposure in order to consolidate learning about expectancy violation. This recommendation has not been experimentally studied and is in contrast to what is typically practiced clinically. CR is often introduced in therapy prior to exposure. The present study will determine whether conducting CR before exposure results in (1) greater initial reductions in expectation following CR before exposure, (2) less expectancy violation, and (3) poorer treatment gains at posttreatment and 1-month followup. Eighty-two participants with claustrophobia will be randomly assigned to receive either CR before exposure or CR after exposure. The intervention will be conducted in a single session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Inhibitory learning is the extinction of a behavioral response through repeated presentations of a conditioned stimulus (CS) in the absence of an unconditioned stimulus (US, CS-noUS). The CS first elicits a behavioral response through excitatory learning - repeated pairing with the US that naturally elicits the same behavioral response (CS-US). One way that inhibitory learning can be maximized in exposure is by violating one's expectancy about CS-US relationship, such that the individual is surprised by the outcome (e.g., CS-noUS). The purpose of the present study is to evaluate the recommendation to avoid cognitive interventions before exposure. Specifically, the aim is to discover whether cognitive interventions before exposure prematurely reduce expected feared outcome ratings, leading to smaller expectancy violation and poorer inhibitory learning (i.e., exposure session or intervention gains) compared to conducting exposures with a consolidation period following exposure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Self-reported proficiency in English language.

  2. High claustrophobic fear as demonstrated by:

    1. Self-report of moderate anxiety (score of at least 2 out of 4) if participant had to lie down in small dark chamber without windows for several minutes.
    2. Endorsement of claustrophobia according to the DSM-5 criteria for Specific Phobia, with or without Criterion F.
    3. Exiting of wooden claustrophobic chamber before 2 minutes have passed, or self-reported fear rating at or exceeding 50/100 fear while in the chamber.

Exclusion Criteria:

  1. Current or past cognitive behavioral therapy (i.e., cognitive therapy, exposure) for claustrophobia or anxiety and related disorders in the past year
  2. Change in dose of psychotropic medication in the past 3 months.
  3. Use of benzodiazepine more frequently than once per week in the past 3 months.
  4. Diagnosis of current (past month) panic disorder or agoraphobia.
  5. Claustrophobia due to or worsened by current (past month) posttraumatic stress disorder (PTSD).
  6. Participants with current (past month) diagnosis of severe depression, bipolar disorder, alcohol/substance use, or psychosis.
  7. Presence of imminent suicidality or homicidality.
  8. Self-reported medical condition that may make it dangerous for participant to experience heightened emotions or arousal (e.g., heart condition/disease, respiratory problem, asthma triggered by intense emotion/arousal).
  9. Participation in professional treatment for claustrophobia between the end of the first lab meeting and the 1-month follow-up (Note: This does not include self-help exposure practice).
  10. Weight or height exceeding maximum capacity of claustrophobic chamber (e.g., weight over 250 lbs, height over 6 feet 5 inches).

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CR Before Exposure
Participants in this arm will receive 15 minutes of CR (preparation) before engaging in exposure and will complete the 15-minute questionnaire filler task after exposure.
Behavioral: CR Before Exposure
Participants complete 15 minutes of CR (Preparation) using the "evidence technique" outlined in the cognitive-behavioral manual Mind Over Mood (Greenberger & Padesky, 2016). This technique involves evaluating the validity of expected feared outcomes. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Finally, participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted after exposure in the other arm of the study.
Experimental: CR After Exposure
Participants in this arm will complete the 15-minute questionnaire filler task before exposure and receive 15 minutes of CR (consolidation) after engaging in exposure.
Behavioral: CR After Exposure
Participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted before exposure in the other arm of the study. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Then, participants complete 15 minutes of CR (Consolidation, Craske et al.'s, 2014) by calculating the difference between predicted and actual expected feared outcomes, and identifying identify (1) whether they believe their feared outcomes occurred (Yes/No), (2) describe how they know this to be true, and (3) reflect on what they learned about their feared outcome or expectancy through exposure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Behavioral Approach at posttreatment and 1-month follow-up
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
The BAT includes eight 30-second cumulative steps designed to elicit increasing fear of suffocation and restriction (e.g., sleeping bag, mask, hand-cuffs, blankets), and is adapted from Deacon et al. (2010). An index of behavioral approach will be calculated by summing the number of points accrued in each step.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Peak Fear at posttreatment and 1-month follow-up
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-report measure assessing the highest level of fear experienced during the final completed step of the BAT at pretreatment from 0% (No Fear) to 100% (Extreme fear).
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Change from pretreatment (i.e., baseline) self-reported claustrophobic anxiety as measured by Claustrophobia Questionnaire: Total score at posttreatment and 1-month follow-up
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of suffocation and restriction. 26 items are summed to create a total score. Total scores range from 0 to 104 with higher scores indicating greater claustrophobic anxiety.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral Approach Test (BAT): Urge to Escape
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-report measure assessing the strongest urge to escape experienced during the final completed step of the BAT at pretreatment from 0% (No Urge to Escape) to 100% (Extreme Urge to Escape).
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-reported Suffocation Anxiety as measured by the Claustrophobia Questionnaire: Suffocation subscale
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Subscale self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of suffocation. Fourteen items are summed to create a subscale score. Scores range from 0 to 56 with greater scores indicating greater suffocation anxiety.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-reported Restriction Anxiety as measured by the Claustrophobia Questionnaire: Restriction subscale
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Subscale self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of restriction. Twelve items are summed to create a subscale score. Scores range from 0 to 48 with greater scores indicating greater restriction anxiety.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-reported Fear of Suffocation as measured by the Claustrophobia General Cognitions Questionnaire: Suffocation subscale
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Subscale self-report measure of the likelihood of claustrophobic cognitions about suffocation while in enclosed spaces. Eight items are summed to create a subscale score. Scores range from 0 to 40 with greater scores indicating greater fear of suffocation.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-reported Fear of Inability to Escape as measured by the Claustrophobia General Cognitions Questionnaire: Inability to Escape subscale
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Subscale self-report measure of the likelihood of claustrophobic cognitions about inability to escape while in enclosed spaces. Eight items are summed to create a subscale score. Scores range from 0 to 40 with greater scores indicating greater fear of inability to escape.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Self-reported Fear of Loss of Control as measured by the Claustrophobia General Cognitions Questionnaire: Loss of control subscale
Time Frame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Subscale self-report measure of the likelihood of claustrophobic cognitions about loss of control while in enclosed spaces. Nine items are summed to create a subscale scores. Scores range from 0 to 45 with greater scores indicating greater fear of loss of control.
Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Expected Feared Outcome: Personal
Time Frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure evaluating the extent to which the participant believes his or her personal expected feared (selected from the CGCQ) would occur in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Suffocation
Time Frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate the extent to which the participant believes he or she will suffocate when in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Restriction
Time Frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate the extent to which the participant believes he or she will become trapped when in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Peak Fear
Time Frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate the highest amount of fear participants believe they will experience in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (No Fear) to 100% (Extreme Fear).
Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Urge to Escape
Time Frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate the strongest urge to escape participants believe they will experience in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (No Urge to Escape) to 100% (Extreme Urge to Escape).
Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Peak Fear
Time Frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
The highest level of fear the participant experienced during the previous claustrophobic exposure trial on a scale from 0% (No Fear) to 100% (Extreme fear).
Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Urge to Escape
Time Frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
The strongest urge to escape the participant experienced during the previous claustrophobic exposure trial on a scale from 0% (No urge to escape) to 100% (Extreme urge to escape).
Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Mean Expectancy Violation: Personal
Time Frame: Mean of 6 Expectancy Violation: Personal change scores calculated on day 1 during the intervention.
The mean of the 6 change scores calculated for Expectancy Violation: Personal (i.e., the difference between the Perceived Actual Outcome: Personal rating after each exposure trial from the Expected Feared Outcome: Personal rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Personal.
Mean of 6 Expectancy Violation: Personal change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Suffocation
Time Frame: Mean of 6 Expectancy Violation: Suffocation change scores calculated on day 1 during the intervention.
The mean of the 6 change scores calculated for Expectancy Violation: Suffocation (i.e., the difference between the Perceived Actual Outcome: Suffocation rating after each exposure trial from the Expected Feared Outcome: Suffocation rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Suffocation.
Mean of 6 Expectancy Violation: Suffocation change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Restriction
Time Frame: Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.
The mean of the 6 change scores calculated for Expectancy Violation: Restriction (i.e., the difference between the Perceived Actual Outcome: Restriction rating after each exposure trial from the Expected Feared Outcome: Restriction rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Restriction.
Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported depression, anxiety, and stress as measured by the Depression Anxiety Stress Scales (21-item version)
Time Frame: Administered once on day 1 at pretreatment.
Self-report questionnaire measuring emotional states of depression, anxiety, and stress in the past week. Each subscale contains 7 items, which are first summed, then doubled. Scores on each subscale can range from 0 to 42, with greater scores indicating greater levels of distress
Administered once on day 1 at pretreatment.
Treatment expectancy and credibility as measured by the Credibility/Expectancy Questionnaire
Time Frame: Administered once on day 1 during the intervention.
Self-report measure assessing the perceived credibility and expectancy of exposure therapy. Answers to each of the 6 items are transformed into standard scores and summed to create either a total score, or a subscale credibility score or treatment expectancy score. The range of scores is not exact given that standard scores indicate deviations from the mean. According to the normal distribution, approximately 99.7% of participants should fall within a score -3 and +3 for each item, yielding a likely total range between -15 and +15 for the total score and -9 and +9 for each subscale score (credibility, treatment expectancy). Greater scores indicating greater treatment expectancy and credibility ratings.
Administered once on day 1 during the intervention.
Perceived Actual Outcome: Personal
Time Frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Personal actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Suffocation
Time Frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Suffocation actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Restriction
Time Frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Restriction actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Expectancy Violation: Personal
Time Frame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Change score calculated by subtracting the Perceived Actual Outcome: Personal rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Personal rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Expectancy Violation: Personal.
Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Expectancy Violation: Suffocation
Time Frame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Change score calculated by subtracting the Perceived Actual Outcome: Suffocation rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Suffocation rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Expectancy Violation: Suffocation.
Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Expectancy Violation: Restriction
Time Frame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Change score calculated by subtracting the Perceived Actual Outcome: Restriction rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Restriction rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Suffocation.
Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirstyn L. Krause

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirstyn L Krause, MA, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB 2018-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results of the study will be disseminated via conference presentations, journal publications, and through the investigator's lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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