Trial Outcomes & Findings for Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD (NCT NCT03707522)
NCT ID: NCT03707522
Last Updated: 2019-08-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
3 months
Results posted on
2019-08-12
Participant Flow
College students recruited via e-mail
Participant milestones
| Measure |
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
|
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
|
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
|
Control + Control
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
36
|
52
|
43
|
|
Overall Study
COMPLETED
|
7
|
9
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
41
|
36
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
Control + Control
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
27
|
41
|
36
|
Baseline Characteristics
Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD
Baseline characteristics by cohort
| Measure |
Growth Mindset + MRF Information
n=31 Participants
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
|
Control + MRF Information
n=36 Participants
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
|
Control + Growth Mindset
n=52 Participants
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
|
Control + Control
n=43 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
18.06 years
STANDARD_DEVIATION .25 • n=5 Participants
|
18.00 years
STANDARD_DEVIATION .00 • n=7 Participants
|
18.02 years
STANDARD_DEVIATION .14 • n=5 Participants
|
18.07 years
STANDARD_DEVIATION .26 • n=4 Participants
|
18.04 years
STANDARD_DEVIATION .19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · Black or African-American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · Native American or American Indian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · Asian/Pacific Islander
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnciity · Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
PHQ-9 (Depression severity)
|
7.06 units on a scale
STANDARD_DEVIATION 6.01 • n=5 Participants
|
5.28 units on a scale
STANDARD_DEVIATION 5.22 • n=7 Participants
|
5.62 units on a scale
STANDARD_DEVIATION 5.34 • n=5 Participants
|
9.65 units on a scale
STANDARD_DEVIATION 7.93 • n=4 Participants
|
6.89 units on a scale
STANDARD_DEVIATION 6.43 • n=21 Participants
|
|
GAD-7 (Anxiety severity)
|
5.97 units on a scale
STANDARD_DEVIATION 5.31 • n=5 Participants
|
5.25 units on a scale
STANDARD_DEVIATION 5.82 • n=7 Participants
|
5.52 units on a scale
STANDARD_DEVIATION 5.08 • n=5 Participants
|
8.26 units on a scale
STANDARD_DEVIATION 6.53 • n=4 Participants
|
6.27 units on a scale
STANDARD_DEVIATION 5.78 • n=21 Participants
|
PRIMARY outcome
Timeframe: 3 months9-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.
Outcome measures
| Measure |
Growth Mindset + MRF Information
n=7 Participants
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
|
Control + MRF Information
n=9 Participants
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
|
Control + Growth Mindset
n=11 Participants
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
|
Control + Control
n=7 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
5.50 units on a scale
Standard Deviation 7.34
|
4.57 units on a scale
Standard Deviation 3.15
|
6.70 units on a scale
Standard Deviation 3.37
|
13.14 units on a scale
Standard Deviation 7.52
|
PRIMARY outcome
Timeframe: 3 months7-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.
Outcome measures
| Measure |
Growth Mindset + MRF Information
n=6 Participants
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
|
Control + MRF Information
n=7 Participants
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
|
Control + Growth Mindset
n=10 Participants
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
|
Control + Control
n=7 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
|
3.67 units on a scale
Standard Deviation 5.75
|
4.43 units on a scale
Standard Deviation 6.29
|
6.90 units on a scale
Standard Deviation 4.68
|
12.14 units on a scale
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 1 participant completed primary but not secondary outcome measure
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.
Outcome measures
| Measure |
Growth Mindset + MRF Information
n=7 Participants
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
|
Control + MRF Information
n=9 Participants
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
|
Control + Growth Mindset
n=10 Participants
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
|
Control + Control
n=7 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)
|
52.1 units on a scale
Standard Deviation 19.6
|
57.3 units on a scale
Standard Deviation 22.9
|
54.8 units on a scale
Standard Deviation 17.8
|
74.3 units on a scale
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2 participants completed primary but not secondary outcomes
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.
Outcome measures
| Measure |
Growth Mindset + MRF Information
n=7 Participants
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
|
Control + MRF Information
n=9 Participants
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
|
Control + Growth Mindset
n=9 Participants
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
|
Control + Control
n=7 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Substance Use Measure (Lee et al., 2015)
|
3.9 units on a scale
Standard Deviation 1.5
|
3.2 units on a scale
Standard Deviation .7
|
3.6 units on a scale
Standard Deviation 1.3
|
4.9 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 3 months28-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.
Outcome measures
| Measure |
Growth Mindset + MRF Information
n=7 Participants
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
|
Control + MRF Information
n=9 Participants
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
|
Control + Growth Mindset
n=11 Participants
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
|
Control + Control
n=7 Participants
2 doses online daily activity scheduling interactive article (control)
Control: 10 minute interactive article describing activity scheduling
|
|---|---|---|---|---|
|
Positive Reframing; Brief COPE (B-COPE; Carver, 1997)
|
2.9 units on a scale
Standard Deviation 1.1
|
2.9 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation .83
|
3.2 units on a scale
Standard Deviation 1.0
|
Adverse Events
Growth Mindset + MRF Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control + MRF Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control + Growth Mindset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control + Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place