Depression, AnxietyNCT04267068
Single Session Intervention to Prevent Common Mental Disorders and Among College Students
A study testing Growth Mindset and Modifiable Risk Factor Information in people with Depression, Anxiety, run by University of Nevada, Reno at 1 site in United States.
Trial summary
The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on depression and anxiety symptom severity. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk… Read more about this study
- Who is it for?
- Ages 17 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Growth Mindset and Modifiable Risk Factor Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 17-26
- College student at the University of Nevada, Reno
Who cannot join
- Under the age of 17, over the age of 26
- Participated in pilot study
- Not a college student at the University of Nevada, Reno
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on depression and anxiety symptom severity. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk factors outlined in the intervention
Read the detailed description
Depression and anxiety disorders (or common mental disorders; CMDs) are increasingly common among college students, with rates comparable to the general population. As such, brief, scalable and transdiagnostic prevention efforts targeting CMDs are needed. In order to address this need, this study aims to evaluate the impact of a single session intervention (SSI) utilizing growth mindset (GM) on CMD symptom severity and investigate the mediating role of changes in modifiable risk factors in the relationship between intervention and CMD symptom reduction. The intervention will adapt existing GM interventions for college students to engage mechanisms in the prevention and management of common mental disorders including engagement in modifiable risk factors. College students will be randomly assigned to complete either a GM intervention or a psychoeducation control.
- Conditions
- Depression, Anxiety
- Being tested
- Growth Mindset and Modifiable Risk Factor Information, Control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Mindset and Modifiable Risk Factor InformationBehavioural
15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety
ControlBehavioural
30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes Receives: Behavioral: Growth Mindset and Modifiable Risk Factor Information |
| Control | Active comparator | Online daily activity scheduling interactive article (control) Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
9-item questionnaire associated containing one item for each symptom of MDD as specified by the DSM. Items consist of a 4-point Likert scale (0="Not at all" to 3="Nearly every day"). Minimum score is 0, maximum score is 27. Higher scores indicate greater depression severity.
Measured: 6 months
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
7-item scale, common, brief measure of anxiety symptom severity. Items consist of a 4-point Likert scale (0="Not at all" to 3="Nearly every day"). Minimum score is 0, maximum score is 21. Higher scores indicate greater anxiety symptom severity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start5 Aug 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Papa, Ph.D., Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267068
- Sponsor's protocol ID
- 1219218
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Intervention to Prevent Common Mental Disorders and Among College Students
- ClinicalTrials.gov ID
- NCT04267068
- Acronym / sponsor ID
- 1219218
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on depression and anxiety symptom severity. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk factors outlined in the intervention
Detailed description
Depression and anxiety disorders (or common mental disorders; CMDs) are increasingly common among college students, with rates comparable to the general population. As such, brief, scalable and transdiagnostic prevention efforts targeting CMDs are needed. In order to address this need, this study aims to evaluate the impact of a single session intervention (SSI) utilizing growth mindset (GM) on CMD symptom severity and investigate the mediating role of changes in modifiable risk factors in the relationship between intervention and CMD symptom reduction. The intervention will adapt existing GM interventions for college students to engage mechanisms in the prevention and management of common mental disorders including engagement in modifiable risk factors. College students will be randomly assigned to complete either a GM intervention or a psychoeducation control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Growth Mindset and Modifiable Risk Factor InformationOnline growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes |
| Control | Active comparator | Behavioral: ControlOnline daily activity scheduling interactive article (control) |
Who may qualify
- Ages
- 17 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 17-26
- College student at the University of Nevada, Reno
Key exclusion criteria (3 listed)
- Under the age of 17, over the age of 26
- Participated in pilot study
- Not a college student at the University of Nevada, Reno
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Mindset and Modifiable Risk Factor Information15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety | Behavioural | Intervention |
| Control30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student | Behavioural | Control |
Primary outcome
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time frame: 6 months
9-item questionnaire associated containing one item for each symptom of MDD as specified by the DSM. Items consist of a 4-point Likert scale (0="Not at all" to 3="Nearly every day"). Minimum score is 0, maximum score is 27. Higher scores indicate greater depression severity.
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
Time frame: 6 months
7-item scale, common, brief measure of anxiety symptom severity. Items consist of a 4-point Likert scale (0="Not at all" to 3="Nearly every day"). Minimum score is 0, maximum score is 21. Higher scores indicate greater anxiety symptom severity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Papa, Ph.D. principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Mindset and Modifiable Risk Factor Information in people with Depression, Anxiety, run by University of Nevada, Reno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.