- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707522
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
162
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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
|
10 minute interactive article describing neuroplasticity
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
|
10 minute interactive article describing modifiable risk factors for depression and anxiety
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)
|
10 minute interactive article describing neuroplasticity
10 minute interactive article describing activity scheduling
|
Placebo Comparator: Control + Control
2 doses online daily activity scheduling interactive article (control)
|
10 minute interactive article describing activity scheduling
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
June 19, 2018
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
December 21, 2018
Study Registration Dates
First Submitted
October 9, 2018
First Submitted That Met QC Criteria
October 14, 2018
First Posted (Actual)
October 16, 2018
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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