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Trial record 9 of 64 for:    MINDSET

Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD

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ClinicalTrials.gov Identifier: NCT03707522
Recruitment Status : Completed
First Posted : October 16, 2018
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Martha Zimmermann, University of Nevada, Reno

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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: Growth mindset Behavioral: Modifiable risk factor (MRF) information Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Growth Mindset Psychoeducation on Modifiable Risk Factors for Common Mental Disorders
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • College freshmen

Exclusion Criteria:

  • Not fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707522


Locations
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United States, Nevada
University of Nevada, Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
University of Nevada, Reno
Investigators
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Principal Investigator: Anthony Papa, PhD University of Nevada, Reno
  Study Documents (Full-Text)

Documents provided by Martha Zimmermann, University of Nevada, Reno:
Informed Consent Form  [PDF] May 31, 2018


Publications:
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Responsible Party: Martha Zimmermann, Principal Investigator, University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03707522     History of Changes
Other Study ID Numbers: Psychoeducation for CMD
First Posted: October 16, 2018    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms