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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Control + Growth mindset | Experimental | Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control) |
|
| Control + Control | Placebo Comparator | 2 doses online daily activity scheduling interactive article (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth mindset | Behavioral | 10 minute interactive article describing neuroplasticity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Papa, PhD | University of Nevada, Reno | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada, Reno | Reno | Nevada | 89557 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16250744 | Background | 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. | |
| 11556941 | Background | 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. |
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College students recruited via e-mail
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Growth mindset: 10 minute interactive article describing neuroplasticity Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety |
| FG001 | 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 Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety Control: 10 minute interactive article describing activity scheduling |
| FG002 | Control + Growth Mindset | Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control) Growth mindset: 10 minute interactive article describing neuroplasticity Control: 10 minute interactive article describing activity scheduling |
| FG003 | Control + Control | 2 doses online daily activity scheduling interactive article (control) Control: 10 minute interactive article describing activity scheduling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Growth mindset: 10 minute interactive article describing neuroplasticity Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Growth mindset: 10 minute interactive article describing neuroplasticity Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Zimmermann | University of Nevada, Reno | 7756368067 | mzimmermann@nevada.unr.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2018 | Apr 15, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2018 | Apr 15, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Modifiable risk factor (MRF) information | Behavioral | 10 minute interactive article describing modifiable risk factors for depression and anxiety |
|
| Control | Behavioral | 10 minute interactive article describing activity scheduling |
|
| 3 months |
| Substance Use Measure (Lee et al., 2015) | 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) | 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 |
| 26273427 | Background | 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. |
| 16717171 | Background | 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. |
| 21138604 | Background | 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. |
| 14975771 | Background | 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. |
| BG001 | 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 Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety Control: 10 minute interactive article describing activity scheduling |
| BG002 | Control + Growth Mindset | Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control) Growth mindset: 10 minute interactive article describing neuroplasticity Control: 10 minute interactive article describing activity scheduling |
| BG003 | Control + Control | 2 doses online daily activity scheduling interactive article (control) Control: 10 minute interactive article describing activity scheduling |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PHQ-9 (Depression severity) | Severity of depression was be measured via the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), a 9-item questionnaire associated containing one item for each symptom of MDD as specified by the DSM. Scores range from 0-27. Scores 0-4 indicate minimal depression, 5-9 indicate mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. | Mean | Standard Deviation | units on a scale |
|
| GAD-7 (Anxiety severity) | Anxiety severity was measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006). The GAD-7 is a common, brief measure of anxiety symptom severity (α = .92). The range of scores is from 0-21. A score of 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| 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 Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety Control: 10 minute interactive article describing activity scheduling |
| OG002 | Control + Growth Mindset | Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control) Growth mindset: 10 minute interactive article describing neuroplasticity Control: 10 minute interactive article describing activity scheduling |
| OG003 | Control + Control | 2 doses online daily activity scheduling interactive article (control) Control: 10 minute interactive article describing activity scheduling |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 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. | 1 participant completed primary but not secondary outcome measure | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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|
|
| Secondary | Substance Use Measure (Lee et al., 2015) | 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. | 2 participants completed primary but not secondary outcomes | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
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| Secondary | Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| EG001 | 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 Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety Control: 10 minute interactive article describing activity scheduling | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control + Growth Mindset | Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control) Growth mindset: 10 minute interactive article describing neuroplasticity Control: 10 minute interactive article describing activity scheduling | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Control + Control | 2 doses online daily activity scheduling interactive article (control) Control: 10 minute interactive article describing activity scheduling | 0 | 0 | 0 | 0 | 0 | 0 |
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