Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety

January 3, 2024 updated by: The Hong Kong Polytechnic University

Examination of Web-based Single-session Growth Mindset Interventions for Reducing Adolescent Anxiety: A Four-arm Cluster Randomized Controlled Trial

Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and one in every four secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy. This study aims to compare the effectiveness of four SSIs: Single-session Intervention of Growth Mindset for Anxiety (SIGMA), SIGMA with booster messages, SSI of Growth mindset of Personality (SSI-GP), and active control using support therapy (ST), in reducing adolescent anxiety. Adolescents (N=731, aged 12-20) from secondary schools have been randomized to one of the four intervention conditions: the SIGMA, SIGMA-BOOSTER, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants reported anxiety symptoms, depression symptoms, and suicidal/self-hurting thoughts (primary outcomes); perceived control, hopelessness, attitude toward help-seeking and psychological well-being (secondary outcomes) at pre-intervention, the 2-week and 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA (including SIGMA and SIGMA-BOOSTER) and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention. We also predict SIGMA (including SIGMA and SIGMA-BOOSTER) will be more effective than SSI-GP. We will use the intention-to-treat principle and generalised estimating equation models for data analysis. This study was conducted from December 2022 to June 2023, with results expected to be available by March 2024. This protocol introduces the implementation content and strategies of growth mindset SSIs among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people.

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.

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.
731

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.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic 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

12 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. secondary school students in grades 7-11;
  2. Chinese youth who can read and write Chinese;
  3. enough visual and auditory abilities to complete the intervention and assessment;
  4. ability to give assent to participate in the study.

Exclusion Criteria:

  1. no parental consent;
  2. inability to stay focused to complete the intervention which is approximately 45 minutes;
  3. intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.

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: Prevention
  • 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: Single-session Intervention of Growth Mindset for Anxiety (SIGMA)
The SIGMA intervention group adapts the SSI-GP protocol in two ways: (a) by introducing the growth mindset of negative emotions rather than personality and (b) providing experiential process of negative emotion change. SIGMA consists of five components: (a) an introduction to emotions and the brain for conveying a scientific understanding of emotion and growth mindset of negative emotions; (b) stories and testimonials from high-school-aged youths who described their beliefs that people's negative emotion states (e.g., anxiety, depression, and stress) are malleable, and how these mindsets influence their coping with anxiety; (c) emotion changing experience induced by short videos; (d) common questions and misconceptions about growth mindset; and (e) self-persuasion writing exercises in which the participants write notes to younger students about the growth mindset of negative emotion.
Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety
This proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.
Experimental: Single-session Intervention on growth mindset of personality (SSI-GP)
The SSI-GP intervention group uses the intervention protocol of Project Personality. Two bilingual native English and Chinese speakers translated it into Chinese and made adaptations to better fit the local context. The SSI-GP consist of five components: (a) an introduction to the brain about the potential of neuroplasticity and behavioural change; (b) written testimonials from older, high-school-aged youths of their belief in change of personality; (c) additional vignettes written by older youths about how growth mindset of personality helped them succeed following setbacks; (d) overview of common questions and misconceptions about growth mindset; and (e) an exercise of writing notes to younger students about the malleability of people's personal traits.
Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety
This proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.
Active Comparator: Active control group: Support therapy (ST)
The control condition is a structurally similar web-based session of supportive therapy. The goals of supportive therapy are to encourage the client to identify and express feelings and to share their emotions-both positive and negative-with close others. The ST group does not teach or emphasize specific skills or beliefs. The active control group includes the same number of activities as do the SIGMA and SSI-GP interventions. Also, to mirror the intervention groups as closely as possible, supportive therapy includes vignettes written by similar school-aged youths, who describe times when they benefited from sharing their feelings with friends or family members.
Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety
This proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.
Experimental: SIGMA-BOOSTER
The SIGMA-BOOSTER group receives the same intervention as the SIGMA group, the only difference is that the SIGMA-BOOSTER group receives booster messages with core intervention content every 2 weeks between the 2-week post-test and the 2-month follow-up survey, that is, a total of 5 weekly booster messages are sent to the SIGMA-BOOSTER group, which will help us determine the most effective way of implementing the intervention.
Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety
This proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.

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
Anxiety Symptoms
Time Frame: baseline
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
baseline
Anxiety Symptoms
Time Frame: 2-week post-intervention
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
2-week post-intervention
Anxiety Symptoms
Time Frame: 8-week post-intervention
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
8-week post-intervention
Depression, and suicidal/self-hurting thoughts
Time Frame: baseline
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
baseline
Depression, and suicidal/self-hurting thoughts
Time Frame: 2-week post-intervention
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
2-week post-intervention
Depression, and suicidal/self-hurting thoughts
Time Frame: 8-week post-intervention
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
8-week post-intervention

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
Perceived control
Time Frame: baseline
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
baseline
Perceived control
Time Frame: 2-week post-intervention
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
2-week post-intervention
Perceived control
Time Frame: 8-week post-intervention
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
8-week post-intervention
Hopelessness
Time Frame: baseline
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
baseline
Hopelessness
Time Frame: 2-week post-intervention
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
2-week post-intervention
Hopelessness
Time Frame: 8-week post-intervention
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
8-week post-intervention
Attitude towards seeking help
Time Frame: baseline
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
baseline
Attitude towards seeking help
Time Frame: 2-week post-intervention
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
2-week post-intervention
Attitude towards seeking help
Time Frame: 8-week post-intervention
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
8-week post-intervention
Psychological wellbeing
Time Frame: baseline
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
baseline
Psychological wellbeing
Time Frame: 2-week post-intervention
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
2-week post-intervention
Psychological wellbeing
Time Frame: 8-week post-intervention
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
8-week post-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.
The Hong Kong Polytechnic University

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.
December 5, 2022

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.
June 30, 2023

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.
June 30, 2023

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).
August 20, 2021

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 26, 2021

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, 2021

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.
January 5, 2024

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.
January 3, 2024

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.
January 1, 2024

More Information

Terms related to this study

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.
  • HSEARS20201004001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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