NCT03707522

Brief Summary

The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on modifiable risk factors (e.g., social contact, physical activity) on engagement with modifiable risk factors. 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
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

June 19, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

October 9, 2018

Results QC Date

April 15, 2019

Last Update Submit

July 2, 2019

Conditions

Depression, Anxiety

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.

    3 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.

    3 months

Secondary Outcomes (3)

  • Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)

    3 months

  • Substance Use Measure (Lee et al., 2015)

    3 months

  • Positive Reframing; Brief COPE (B-COPE; Carver, 1997)

    3 months

Study Arms (4)

Growth mindset + MRF Information

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 mindsetBehavioral: Modifiable risk factor (MRF) information

Control + MRF information

EXPERIMENTAL

Online daily activity scheduling interactive article (control) followed by equal length interactive article describing the relationship between modifiable risk factors and mental health outcomes

Behavioral: Modifiable risk factor (MRF) informationBehavioral: Control

Control + Growth mindset

EXPERIMENTAL

Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)

Behavioral: Growth mindsetBehavioral: Control

Control + Control

PLACEBO COMPARATOR

2 doses online daily activity scheduling interactive article (control)

Behavioral: Control

Interventions

Growth mindsetBEHAVIORAL

10 minute interactive article describing neuroplasticity

Control + Growth mindsetGrowth mindset + MRF Information
Modifiable risk factor (MRF) informationBEHAVIORAL

10 minute interactive article describing modifiable risk factors for depression and anxiety

Control + MRF informationGrowth mindset + MRF Information
ControlBEHAVIORAL

10 minute interactive article describing activity scheduling

Control + ControlControl + Growth mindsetControl + MRF information

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • College freshmen

You may not qualify if:

  • Not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Related Publications (6)

  • Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

    PMID: 16250744BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • Lee JP, Lee RM, Hu AW, Kim OM. Ethnic Identity as a Moderator against Discrimination for Transracially and Transnationally Adopted Korean American Adolescents. Asian Am J Psychol. 2015 Jun;6(2):154-163. doi: 10.1037/a0038360.

    PMID: 26273427BACKGROUND

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND

  • Zazpe I, Bes-Rastrollo M, Ruiz-Canela M, Sanchez-Villegas A, Serrano-Martinez M, Martinez-Gonzalez MA. A brief assessment of eating habits and weight gain in a Mediterranean cohort. Br J Nutr. 2011 Mar;105(5):765-75. doi: 10.1017/S0007114510004149. Epub 2010 Dec 8.

    PMID: 21138604BACKGROUND

  • Ottenbreit ND, Dobson KS. Avoidance and depression: the construction of the cognitive-behavioral avoidance scale. Behav Res Ther. 2004 Mar;42(3):293-313. doi: 10.1016/S0005-7967(03)00140-2.

    PMID: 14975771BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Martha Zimmermann
Organization
University of Nevada, Reno
mzimmermann@nevada.unr.edu
7756368067

Study Officials

  • Anthony Papa, PhD

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 16, 2018

Study Start

June 19, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

August 12, 2019

Results First Posted

August 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)