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Single Session Intervention to Prevent Common Mental Disorders and Among College Students

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growth Mindset and Modifiable Risk Factor Information
Control
Sponsored by
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Anxiety

Eligibility Criteria

17 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nevada, Reno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes

Online daily activity scheduling interactive article (control)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2019
Last Updated
November 4, 2020
Sponsor
University of Nevada, Reno
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1. Study Identification

Unique Protocol Identification Number
NCT04267068
Brief Title
Single Session Intervention to Prevent Common Mental Disorders and Among College Students
Official Title
Single Session Intervention to Prevent Common Mental Disorders and Among College Students
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Reno

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Online daily activity scheduling interactive article (control)
Intervention Type
Behavioral
Intervention Name(s)
Growth Mindset and Modifiable Risk Factor Information
Intervention Description
15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Description
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.
Time Frame
6 months
Title
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Papa, Ph.D.
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Single Session Intervention to Prevent Common Mental Disorders and Among College Students

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