Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder

May 23, 2022 updated by: Universitat Jaume I

Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder: A Randomized Controlled Trial

The aim of this study is to assess the efficacy of an online CBT-based intervention combined with an Ecological Momentary Intervention (EMI) and different complementary tools for the treatment of problem gambling and gambling disorder. The main hypothesis is that the Internet-based psychological intervention group will obtain better results than the waiting list control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N=67) or an intervention group (N=67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioural therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 minutes. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help.

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 (Anticipated)

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.
134

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Laura Díaz Sanahuja, PhDstudent
  • Phone Number: +34 964387651
  • Email: lsanahuj@uji.es

Study Contact Backup

  • Name: Juana M Bretón López, Lecturer
  • Phone Number: +34 964387642
  • Email: breton@uji.es

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years or older.
  • Willingness to participate in the study and sign informed consent.
  • To have and handle the computer, Internet and an email address.
  • Ability to understand, read and write Spanish.
  • Based on the cut-off points established by the Norc diagnostic screen for gambling disorders (NODS; adapted by Becoña, 2004): be a problem gambler (3-4 items) or a pathological gambler (5 or more items).
  • Willingness to provide the name of a co-therapist to validate the information provided, as well as to be able to locate the patient in follow-ups.
  • Willing to provide follow-up data on gambling.

Exclusion Criteria:

  • Any serious mental disorder (Bipolar and Related Disorders and Schizophrenia Spectrum and Other Psychotic Disorders), medical illness, and moderate or severe alcohol and/or substance use disorder, that prevents the program from being carried out.
  • If their gambling behaviour occurs in the context of a Maniac Episode or because of the intake of dopaminergic medication (e.g. Parkinson's disease).
  • The presence of high suicidal risk.
  • Receiving another psychological treatment while the study is still ongoing.
  • Receiving pharmacological treatment is not an exclusion criterion during the study period, but participants having an increase and/or change in the medication 2 months prior to enrollment will not be considered for the trial. Also, the increase and/or change in the medication during the study period in the experimental group will imply the participant's exclusion from subsequent analyses (a decrease in pharmacological treatment is accepted).

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
  • Masking: NONE

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: Gambling Internet-based Protocol
Intervention group that carries out the Gambling Internet-based Protocol based on Cognitive and Behavioral Therapy (CBT) and receives support by the therapist (a weekly 10-minute phone call without clinical content). In addition, they will receive one notification per day to respond to the EMI questions at 8 PM. The EMI includes immediate automatic feedback depending on the participant's responses.
Behavioral: Gambling Internet-based Protocol
Gambling Internet-based protocol is a multimedia interactive and self-help program for problem and pathological gamblers, which will allow individuals to learn and practice adaptive ways to cope with this problem. The main therapeutic modules included in this program are: 1) Motivational for change; 2) Psychoeducation; 3) Stimulus control (e.g. self-prohibition and blocking of usual gambling websites with therapist confirmation) and responsible return of debts; 4) Cognitive restructuring; 5) Emotion regulation; 6) Planning of significant activities; 7) Coping skills and exposure with response prevention; 8) Relapse prevention.
NO_INTERVENTION: Waiting List Control Group
Participants in a 12-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period.

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 in the Gambling Symptom Assessment Scale (G-SAS; Kim, Grant, Potenza, Blanco & Hollander, 2009) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
The G-SAS is a 12-item self-report instrument that assesses gambling symptom severity. All items are referred to as an average symptom based on the past 7 days.The statements correspond with gambling urges;average frequency, duration,and control of thoughts associated with gambling;time spent on gambling or gambling-related behaviour;anticipatory excitement caused by an imminent gambling act; pleasure associated with winning;emotional distress;and personal trouble.All items are rated on a 4-point scale (total score: 0-48).The higher score the higher gambling symptoms severity (mild=8-20;moderate=21-30;severe=31-40;extreme=41-48).It shows high internal consistency (α=0.87) and good convergent validity with other measures associated with gambling symptom severity in a sample of pathological gamblers.Because this instrument has not a Spanish version, standardized procedures were followed to adapt G-SAS to the Spanish language.Cronbach's alpha will be calculated with the data at hand.
Up to 12 months
Change in the Gambling-Related Cognitions Scale (GRCS-S; Raylu & Oei, 2004; Spanish validation Del Prete, Steward, Navas, Fernández-Aranda, Jiménez-Murcia, Oei & Perales, 2016) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
The GRCS-S is a self-report instrument aimed to assess five domains of gambling-related cognitions (interpretative bias, IB; the illusion of control, IC; predictive control, PC; gambling expectancies, GE; and perceived inability to stop gambling, ISG). It comprises 23 items which are worded on a 7-point Likert type scale (1= I completely disagree; 7=I completely agree). The total score consists of adding the values of the whole items. The score for each subscale is obtained adding the values for the items' set that represent each subscale. The higher the total score the higher the number of gambling-related cognitions presented. GRCS-S shows adequate psychometric properties in a sample composed by treatment-seeking gamblers and non-treatment-seeking gamblers: the concurrent and criterion-related validity are verified, the full scale reliability is 0.95, and for each subscale reliability ranges from 0.68 to 0.91 (GE= 0.77; IC=0.68; PC=0.84; ISG=0.91; IB= 0.89).
Up to 12 months

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
Change in the Gambling Self-Efficacy Questionnaire (GSEQ; May, Whelan, Steenbergh & Meyers, 2003; Winfree, Ginley, Whelan, & Meyers, 2014) at Pre-intervention, Post-module, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
The GSEQ is a self-report instrument that assesses perceived self-efficacy to control gambling in high-risk situations through 16 six-point Likert scale items. Participants are asked to indicate how confident they feel in a scale that ranges from 0% (Not at all confident) to 100% (Very confident) in increments of 20%. Specifically, it includes intrapersonal (e.g. unpleasant emotions, physical discomfort, pleasant emotions, testing personal control, and urges and temptations) and interpersonal factors (conflict with others, social pressure and pleasant times with others) based on Marlatt's (1985) model of relapse situations for addictive behaviors. The overall score is calculated taking into account the mean response from all items, and it can range from 0 to 100. The higher overall score the higher overall confidence about controlling their gambling behavior. There is evidence of convergent and discriminant validity, and the internal consistency is high (α=0.99) in a community sample.
Up to 12 months
Change in the University of Rhode Island Change Assessment Scale (URICA; McConnaughy, Prochaska & Velicer, 1983; Spanish validation Gómez-Peña et al., 2011) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
The URICA is a 32 items self-report instrument that includes four subscales and assesses four of the five stages of change proposed by Prochaska & DiClemente (precontemplation, PC; contemplation, C; action, A; and maintenance, M) on a 5-point Likert type scale (1=strongly disagree; 5=strongly agree). Scores for each subscale range from 8 to 40, and are obtained adding the value of the 5 items that include each subscale. A second-order score is obtained and is referred to the degree of 'Readiness to change' (C+A+M-PC). The URICA shows good psychometric proprieties in a sample of pathological gamblers. The internal consistency values are adequate for the stages of change assessed as well as for the total score corresponding to 'Readiness to change'. Specifically, the Cronbach's alpha coefficients ranges from 0.74 to 0.84 taking into account the different stages (Precontemplation=0.74; Contemplation=0.80; Action=0.84; and Maintenance=0.74) and for the total score is 0.84.
Up to 12 months
Change in the EMI measures during procedure.
Time Frame: During procedure.
Gambling urge intensity (on a scale from 0 "Not at all" to 10 "maximum") and frequency (on a 5-point Likert scale from "Never" to "Almost always"), self-efficacy to cope with gambling urges (on a scale from 0 "Not at all" to 10 "Completely"), gambling behaviour (yes/no), money wagered (euros), and amount of time gambling (minutes) are also assessed for 90 days in the experimental group.
During procedure.

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
Change in the NORC DSM-IV Screen for Gambling Problems (NODS; Gernstein et al., 1999; Becoña, 2004) at Pre-intervention (screening), Post-intervention, 3-, 6- and 12 months Follow-up.
Time Frame: Up to 12 months
The NODS is a hierarchically structured 17-item screen that is designed to assess the at-risk, problem and pathological gambling. It is referred to the experience in gambling both throughout their life and in the last year, with dichotomous choice questions (Yes / No). The total score ranges from 0 to 10 (1-2 affirmative items correspond with at-risk gambling; 3-4 items with problem gambling; and 6 or more with pathological gambling). The data obtained on specificity and sensitivity is good, its test-retest reliability is 0.98, and its validity is excellent considering that it corresponds strictly to the DSM-IV criteria. We will use the 12-month version at pre-test to establish the diagnosis based on the DSM-IV-TR, and the 3-month version of the NODS to assess the progress made in gambling severity throughout the intervention and in follow-up assessments.
Up to 12 months
Mini International Neuropsychiatric Interview - The M.I.N.I. 7.0.2, 8/8/16 version (Sheehan, 2016).
Time Frame: Pre-intervention (screening)
MINI is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5 (major depressive episode; obsessive-compulsive disorder; posttraumatic stress disorder; alcohol use disorder; substance use disorder; any psychotic disorder; anorexia nervosa; bulimia nervosa; generalized anxiety disorder; medical, organic, drug cause ruled out; and antisocial personality disorder). Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if it is needed. Validity and reliability are supported and similar properties to the SCID-P for DSM-III-R and the CIDI are shown, but it can be administered in a much shorter period of time.
Pre-intervention (screening)
Gambling history interview and current gambling situation and related variables assessment at the pre-intervention (screening)
Time Frame: Pre-intervention (screening)
This interview is based on the Structured Interview of Gambling History (Echeburúa & Báez, 1994). In addition to making a selection of five of the items of the first interview to assess parents' gambling habits, the onset, and aggravation of the patient's gambling behaviour (including ups and downs and periods of abstinence), other five interesting items of variables related to the current gambling situation are added. They are referred to economic debts, to which people or entities they owe money and the specific amount, if they have access to money and the forms through which they can access, what they have done so far to solve the problem, how long it has happened since the last bet and the specific risk places. The 10 items are open-ended questions and offer qualitative data to understand the participants' context and gambling situation.
Pre-intervention (screening)
Change in the Hospital Anxiety Depression Scale (HADS) (Zigmond and Snaith, 1983; Castresana et al., 1995) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
HADS is a self-report instrument that consists of 14 items and has two subscales: seven items measure depressive symptoms and the other seven items anxiety symptoms. Respondents are asked to indicate which option fits them the most, taking the past week into account. Each item is rated in a four-point scale from 0 to 3. The scores for both subscales are obtained by adding all the items values, and both ranges from 0 to 21. Scores up to 8 indicates there is absence of significant morbidity, from 8 to 10 corresponds to a borderline case, and scores higher than 10 indicates morbidity. The internal consistency rates from 0.42 to 0.71 (p<0.01) regarding depression subscale, and from 0.36 to 0.64 regarding anxiety subscale.
Up to 12 months
Change in the Overall Depression Severity and Impairment Scale (ODSIS; Bentley, Gallagher, Carl & Barlow, 2014; Spanish validation Mira et al., 2019) at Post-module.
Time Frame: During procedure.
ODSIS is a 5-item self-report instrument that evaluates a unidimensional factor referred to the severity and functional impairment associated with depression during the last week. There are five response options for each item and they are coded from 0 to 4. The total score is obtained adding the values of all the items and it ranges from 0 to 20. Scores of 5 or higher indicate depressive symptoms. This scale is validated online considering a sample of patients with depressive or anxiety disorders. It shows an excellent internal consistency (α=0.92), and the construct, convergent and discriminant validities are evidenced.
During procedure.
Change in the Overall Anxiety Severity and Impairment Scale (OASIS; Campbell-Sills et al., 2009; Spanish validation González-Robles et al., 2018) at Post-module.
Time Frame: During procedure.
OASIS is a 5-items self-report instrument that assesses a unidimensional factor referred to the severity and frequency of anxiety symptoms, as well as to the behavioral avoidance and the functional impairment related to these symptoms in the previous week. There are five response options for each item and they are coded from 0 to 4. The total score is obtained adding the values of all the items and it ranges from 0 to 20. Scores higher than 8 show the occurrence of anxiety symptoms. This scale is validated online in a sample of patients with depression and anxiety. It shows good internal consistency (α=0.86) and adequate convergent and discriminant validities, as well as sensitivity to change.
During procedure.
Change in the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004: Spanish validation Hervás & Jódar, 2008) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
DERS is a self-report measure that includes 28 items and it assesses five factors related to difficulties in emotion regulation processes: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Participants should report in a 5-point Likert type scale how often the items are applied for themselves from 1 (almost never; 0-10%) to 5 (almost always; 91-100%). A score for each subscale is obtained adding the values of the set of items that correspond to each subscale and taking into account reversed items. A final score is obtained adding the values of all items. The higher scores the higher difficulties in emotion regulation processes. DERS has good psychometric properties in the general population. Internal consistency is 0.93, test-retest reliability is adequate, and convergent and incremental validities are evidenced.
Up to 12 months
Change in the Positive and Negative Affect Schedule (PANAS; Watson, Clark & Tellegen, 1988) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
The PANAS is made up of 20 items that assess two independent dimensions, positive affect (PA) and negative affect (NA). PANAS is used for measuring trait and state affectivity. Each dimension consists of 10 items which are rated on a 5-point Likert type scale (1=very slightly or not at all; 2= a little; 3=moderately; 4; quite a bit; 5=very much). Participants should indicate to what extent they have experienced each emotion generally and during the last week. Total scores are calculated adding the values of the items for each dimension, and it ranges from 10 to 50. Psychometric properties are not yet available since the Spanish validation in clinical patients is ongoing, but Cronbach's alpha will be calculated with the data at hand.
Up to 12 months
Change in the Short UPPS-P Impulsivity Scale (UPPS-P; Lynam, Smith, Whiteside & Cyders, 2006; Spanish validation Cándido, Orduña, Perales, Verdejo-García & Billieux, 2012) at Pre-intervention, Post-intervention, 3-, 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
UPPS-P assess five impulsivity traits (negative urgency, lack of premeditation, lack of perseverance, sensation seeking and positive urgency) through 20 four-point Likert scale items (1=strongly agree; 4=strongly disagree). Scores of each of the five factors and a global score of the UPPS-P are obtained taking into account direct and inverse items. It is calculated adding the values of the four items that include each factor. The higher the score the higher impulsivity. UPPS-P present good psychometric properties in a sample of university students. Internal consistency is acceptable (α ranges from 0.61 to 0.81) and external validity is supported.
Up to 12 months
Change in the Quality Life Index (QLI; Mezzich, Cohen & Ruipérez, 1999; Spanish validation Mezzich, Ruipérez, Pérez, Yoon, Liu & Mahmud, 2000) at Pre-intervention, Post-intervention, 3- , 6-, and 12 months Follow-up.
Time Frame: Up to 12 months
QLI is a 10-item self-report instrument that assess one concept of quality of life taking into account 10 dimensions on a ten-point Likert type scale (1=poor; 10=excellent): physical well-being, psychological/emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social-emotional support, community and services support, personal fulfillment, spiritual fulfillment and global perception of quality of life. Total score corresponds to the average of the scores of the set of items and rages from 1 to 10 (1-4,5=perception of the quality of life below the average; 4,6-8,1= perception of the quality of life in the average; 8,2-10=perception of the quality of life above average). Internal consistency (α=0.89) and test-retest reliability (0.89) are high, and the discriminant validity is evidenced in a sample of psychiatric patients.
Up to 12 months
Change in the System Usability Scale (SUS; Castilla et al., 2016) after the first use of the program (after the welcome module) and post-intervention.
Time Frame: Up to 3 months
SUS is a 10-item self-report instrument aimed to assess the system usability opinion in a 5-Likert type scale that ranges from 1 ( Completely disagree) to 5 (Completely agree). Psychometric properties are not yet available since the Spanish validation in clinical patients is ongoing, but Cronbach's alpha will be calculated with the data at hand.
Up to 3 months

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.
Universitat Jaume I

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.
  • Study Director: Juana M Bretón López, Lecturer, Jaume I University
  • Study Director: Azucena García Palacios, Lecturer, Jaume I 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

Helpful Links

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 (ANTICIPATED)

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.
February 1, 2023

Primary Completion (ANTICIPATED)

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.
December 1, 2024

Study Completion (ANTICIPATED)

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.
December 1, 2024

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 22, 2019

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 28, 2019

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 30, 2019

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.
May 24, 2022

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.
May 23, 2022

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.
May 1, 2022

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.
  • UJI-A2016-14

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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