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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04267068
Other study ID # 1219218
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2019
Est. completion date July 13, 2020

Study information

Verified date November 2020
Source University of Nevada, Reno
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 factors outlined in the intervention


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.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date July 13, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 26 Years
Eligibility Inclusion Criteria: - Age 17-26 - College student at the University of Nevada, Reno Exclusion Criteria: - Under the age of 17, over the age of 26 - Participated in pilot study - Not a college student at the University of Nevada, Reno

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Growth Mindset and Modifiable Risk Factor Information
15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety
Control
30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student

Locations

Country Name City State
United States University of Nevada, Reno Reno Nevada

Sponsors (1)

Lead Sponsor Collaborator
University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
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