NCT04267068

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

November 5, 2019

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Behavioral: Growth Mindset and Modifiable Risk Factor Information

Control

ACTIVE COMPARATOR

Online daily activity scheduling interactive article (control)

Behavioral: Control

Interventions

15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety

Intervention
ControlBEHAVIORAL

30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student

Control

Eligibility Criteria

Age17 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 17-26
  • College student at the University of Nevada, Reno

You may not qualify if:

  • Under the age of 17, over the age of 26
  • Participated in pilot study
  • Not a college student at the University of Nevada, Reno

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Anthony Papa, Ph.D.

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

February 12, 2020

Study Start

August 5, 2019

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations