Depression, Anxiety
Conditions
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.
Interventions
BEHAVIORALGrowth mindset
10 minute interactive article describing neuroplasticity
BEHAVIORALModifiable risk factor (MRF) information
10 minute interactive article describing modifiable risk factors for depression and anxiety
BEHAVIORALControl
10 minute interactive article describing activity scheduling
Sponsors
University of Nevada, Reno
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* College freshmen
Exclusion criteria
* Not fluent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 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. |
| Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 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. |
| Substance Use Measure (Lee et al., 2015) | 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. |
| Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 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. |
Countries
United States
Participant flow
Recruitment details
College students recruited via e-mail
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 36 |
| 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 | 52 |
| Control + Control 2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling | 43 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 24 | 27 | 41 | 36 |
Baseline characteristics
| Characteristic | Total | Growth Mindset + MRF Information | Control + MRF Information | Control + Control | Control + Growth Mindset |
|---|---|---|---|---|---|
| Age, Continuous | 18.04 years STANDARD_DEVIATION 0.19 | 18.06 years STANDARD_DEVIATION 0.25 | 18.00 years STANDARD_DEVIATION 0 | 18.07 years STANDARD_DEVIATION 0.26 | 18.02 years STANDARD_DEVIATION 0.14 |
| GAD-7 (Anxiety severity) | 6.27 units on a scale STANDARD_DEVIATION 5.78 | 5.97 units on a scale STANDARD_DEVIATION 5.31 | 5.25 units on a scale STANDARD_DEVIATION 5.82 | 8.26 units on a scale STANDARD_DEVIATION 6.53 | 5.52 units on a scale STANDARD_DEVIATION 5.08 |
| PHQ-9 (Depression severity) | 6.89 units on a scale STANDARD_DEVIATION 6.43 | 7.06 units on a scale STANDARD_DEVIATION 6.01 | 5.28 units on a scale STANDARD_DEVIATION 5.22 | 9.65 units on a scale STANDARD_DEVIATION 7.93 | 5.62 units on a scale STANDARD_DEVIATION 5.34 |
| Race/Ethnicity, Customized Race/ethnciity Asian/Pacific Islander | 23 Participants | 4 Participants | 5 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/ethnciity Black or African-American | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/ethnciity Hispanic or Latino | 24 Participants | 5 Participants | 5 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/ethnciity Native American or American Indian | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnciity Other | 12 Participants | 4 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/ethnciity White | 95 Participants | 17 Participants | 22 Participants | 27 Participants | 29 Participants |
| Region of Enrollment United States | 162 Participants | 31 Participants | 36 Participants | 43 Participants | 52 Participants |
| Sex: Female, Male Female | 43 Participants | 7 Participants | 11 Participants | 14 Participants | 11 Participants |
| Sex: Female, Male Male | 119 Participants | 24 Participants | 25 Participants | 29 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Mindset + MRF Information | Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006) | 3.67 units on a scale | Standard Deviation 5.75 |
| Control + MRF Information | Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006) | 4.43 units on a scale | Standard Deviation 6.29 |
| Control + Growth Mindset | Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006) | 6.90 units on a scale | Standard Deviation 4.68 |
| Control + Control | Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006) | 12.14 units on a scale | Standard Deviation 7.69 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Mindset + MRF Information | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 5.50 units on a scale | Standard Deviation 7.34 |
| Control + MRF Information | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 4.57 units on a scale | Standard Deviation 3.15 |
| Control + Growth Mindset | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 6.70 units on a scale | Standard Deviation 3.37 |
| Control + Control | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 13.14 units on a scale | Standard Deviation 7.52 |
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.
Time frame: 3 months
Population: 1 participant completed primary but not secondary outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Mindset + MRF Information | Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 52.1 units on a scale | Standard Deviation 19.6 |
| Control + MRF Information | Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 57.3 units on a scale | Standard Deviation 22.9 |
| Control + Growth Mindset | Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 54.8 units on a scale | Standard Deviation 17.8 |
| Control + Control | Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003) | 74.3 units on a scale | Standard Deviation 25.2 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Mindset + MRF Information | Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 2.9 units on a scale | Standard Deviation 1.1 |
| Control + MRF Information | Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 2.9 units on a scale | Standard Deviation 1.1 |
| Control + Growth Mindset | Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 2.4 units on a scale | Standard Deviation 0.83 |
| Control + Control | Positive Reframing; Brief COPE (B-COPE; Carver, 1997) | 3.2 units on a scale | Standard Deviation 1 |
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.
Time frame: 3 months
Population: 2 participants completed primary but not secondary outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Growth Mindset + MRF Information | Substance Use Measure (Lee et al., 2015) | 3.9 units on a scale | Standard Deviation 1.5 |
| Control + MRF Information | Substance Use Measure (Lee et al., 2015) | 3.2 units on a scale | Standard Deviation 0.7 |
| Control + Growth Mindset | Substance Use Measure (Lee et al., 2015) | 3.6 units on a scale | Standard Deviation 1.3 |
| Control + Control | Substance Use Measure (Lee et al., 2015) | 4.9 units on a scale | Standard Deviation 2.5 |