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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Depression, Anxiety
Interventions Behavioral: Growth mindset
Behavioral: Modifiable risk factor (MRF) information
Behavioral: Control
Enrollment 162
Recruitment Details College students recruited via e-mail
Pre-assignment Details  
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Period Title: Overall Study
Started 31 36 52 43
Completed 7 9 11 7
Not Completed 24 27 41 36
Reason Not Completed
Lost to Follow-up             24             27             41             36
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control Total
Hide Arm/Group Description

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Total of all reporting groups
Overall Number of Baseline Participants 31 36 52 43 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
18.06  (.25) 18.00  (.00) 18.02  (.14) 18.07  (.26) 18.04  (.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
Female
7
  22.6%
11
  30.6%
11
  21.2%
14
  32.6%
43
  26.5%
Male
24
  77.4%
25
  69.4%
41
  78.8%
29
  67.4%
119
  73.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/ethnciity Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
White
17
  54.8%
22
  61.1%
29
  55.8%
27
  62.8%
95
  58.6%
Hispanic or Latino
5
  16.1%
5
  13.9%
6
  11.5%
8
  18.6%
24
  14.8%
Black or African-American
1
   3.2%
1
   2.8%
3
   5.8%
0
   0.0%
5
   3.1%
Native American or American Indian
0
   0.0%
2
   5.6%
1
   1.9%
0
   0.0%
3
   1.9%
Asian/Pacific Islander
4
  12.9%
5
  13.9%
9
  17.3%
5
  11.6%
23
  14.2%
Other
4
  12.9%
1
   2.8%
4
   7.7%
3
   7.0%
12
   7.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
31
 100.0%
36
 100.0%
52
 100.0%
43
 100.0%
162
 100.0%
PHQ-9 (Depression severity)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
7.06  (6.01) 5.28  (5.22) 5.62  (5.34) 9.65  (7.93) 6.89  (6.43)
[1]
Measure Description: 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.
GAD-7 (Anxiety severity)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 36 participants 52 participants 43 participants 162 participants
5.97  (5.31) 5.25  (5.82) 5.52  (5.08) 8.26  (6.53) 6.27  (5.78)
[1]
Measure Description: 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.
1.Primary Outcome
Title Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description:

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Overall Number of Participants Analyzed 7 9 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.50  (7.34) 4.57  (3.15) 6.70  (3.37) 13.14  (7.52)
2.Primary Outcome
Title Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description:

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Overall Number of Participants Analyzed 6 7 10 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.67  (5.75) 4.43  (6.29) 6.90  (4.68) 12.14  (7.69)
3.Secondary Outcome
Title Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant completed primary but not secondary outcome measure
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description:

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Overall Number of Participants Analyzed 7 9 10 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.1  (19.6) 57.3  (22.9) 54.8  (17.8) 74.3  (25.2)
4.Secondary Outcome
Title Substance Use Measure (Lee et al., 2015)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants completed primary but not secondary outcomes
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description:

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Overall Number of Participants Analyzed 7 9 9 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (1.5) 3.2  (.7) 3.6  (1.3) 4.9  (2.5)
5.Secondary Outcome
Title Positive Reframing; Brief COPE (B-COPE; Carver, 1997)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description:

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

Overall Number of Participants Analyzed 7 9 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (1.1) 2.9  (1.1) 2.4  (.83) 3.2  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
 
Arm/Group Title Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Hide Arm/Group Description

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

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

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

2 doses online daily activity scheduling interactive article (control)

Control: 10 minute interactive article describing activity scheduling

All-Cause Mortality
Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Growth Mindset + MRF Information Control + MRF Information Control + Growth Mindset Control + Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martha Zimmermann
Organization: University of Nevada, Reno
Phone: 7756368067
EMail: mzimmermann@nevada.unr.edu
Layout table for additonal information
Responsible Party: Martha Zimmermann, University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03707522     History of Changes
Other Study ID Numbers: Psychoeducation for CMD
First Submitted: October 9, 2018
First Posted: October 16, 2018
Results First Submitted: April 15, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019