Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD

July 2, 2019 updated by: Martha Zimmermann, University of Nevada, Reno

The Effect of Growth Mindset Psychoeducation on Modifiable Risk Factors for Common Mental Disorders

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89557
        • University of Nevada, Reno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • College freshmen

Exclusion Criteria:

  • Not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Growth mindset + MRF Information
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
10 minute interactive article describing neuroplasticity
Behavioral: Modifiable risk factor (MRF) information
10 minute interactive article describing modifiable risk factors for depression and anxiety
Experimental: Control + MRF information
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) information
10 minute interactive article describing modifiable risk factors for depression and anxiety
Behavioral: Control
10 minute interactive article describing activity scheduling
Experimental: Control + Growth mindset
Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)
Behavioral: Growth mindset
10 minute interactive article describing neuroplasticity
Behavioral: Control
10 minute interactive article describing activity scheduling
Placebo Comparator: Control + Control
2 doses online daily activity scheduling interactive article (control)
Behavioral: Control
10 minute interactive article describing activity scheduling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame: 3 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.
3 months
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
Time Frame: 3 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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)
Time Frame: 3 months
The scale contains 31 items assessing cognitive avoidance and behavioral avoidance of social and non-social avoidance. The scale uses a 5-item Likert scale (1="Not at all true for me" to 5="Extremely true for me"). Total scale range from 0-155. The behavioral social factor contains 8 items. Items are summed. Minimum score is 8, maximum score is 40. The cognitive nonsocial scale contains 10 items. Minimum score is 10. Maximum score is 50. The cognitive social subscale consists of 7 items. Minimum score is 7, maximum score is 35. The behavioral nonsocial subscale consists of 6 items. Minimum score is 6, maximum score is 30. Higher scores indicate higher levels of avoidance.
3 months
Substance Use Measure (Lee et al., 2015)
Time Frame: 3 months
3-item substance use measure including frequency of alcohol use, cigarette use and drug use. Items are measured using a five-point Likert scale (1="never or not at all" to 5="almost always"). The scale is scored by summing items. Minimum score is 3, maximum score is 15. Higher scores indicate more frequent substance use.
3 months
Positive Reframing; Brief COPE (B-COPE; Carver, 1997)
Time Frame: 3 months
28-item scale assessing various dimensions of healthy and unhealthy coping. This include 14 subscales: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Each subscale consists of two items. Subscales are scored by summing items. Scale consists of 4-item Likert scale (1="I haven't been doing this at all" to 4 "I've been doing this a lot"). Minimum score is 2, maximum score is 8 on each subscale. Higher scores indicate greater use of coping strategy. Positive reframing subscale was used.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nevada, Reno

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Papa, PhD, University of Nevada, Reno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Psychoeducation for CMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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