Online Wellness Intervention for College Students

Depression Clinical Trial

Official title:

An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740411
• Other study ID #: 844589
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2021
• Source: University of Pennsylvania
• Contact: Akash Wasil, MA
• Phone: 631-766-9466
• Email: wasil[@]sas.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old and a student at a participating university. Access to the internet.

Exclusion Criteria:

• Cannot have participated in a previous version of COMET.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Well-being

Intervention

Behavioral:
• The Common Elements Toolbox (COMET)
COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Indiana University, Ohio State University, University of Missouri, St. Louis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Patient Health Questionnaire-9 (PHQ-9)	Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.	Up to 8 weeks post-intervention
Primary	Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)	Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.	Up to 8 weeks post-intervention
Primary	Change in the Short Warwick-Edinburgh Mental Well-being Scale	Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.	Up to 8 weeks post-intervention
Primary	Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).	Well-being questionnaire with questions related to positive emotion, engagement, relationships, meaning, accomplishment, negative emotion, and health. Scores on each item range from 0 to 5. Lower scores indicate less well-being. We are using a shortened version of this questionnaire with 12 items. We have also modified the items to ask participants about their experiences over the past 48 hours. We predict that our intervention will produce changes in the positive emotion and negative emotion subscales. Each subscale consists of 3 items.	Up to 8 weeks post-intervention
Secondary	Ratings on the Acceptability of Intervention Measure (AIM)	Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.	Immediately after the intervention
Secondary	Ability to Cope with COVID-19	2 questions related to their ability to cope with stressors over the past two weeks relating to the COVID-19 pandemic. Participants answered these questions on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: a) if they have been able to handle lifestyle changes due to the coronavirus and b) if the pandemic has had an extremely negative impact on their life.	Up to 8 weeks post-intervention
Secondary	Change in Secondary Control	We administered three items to assess secondary control, derived from the Secondary Control Scale for Children (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). Scores on each item range from 0-4, with higher scores indicating more secondary control.	Up to 8 weeks post-intervention
Secondary	Change in the Positive and Negative Affect Schedule	Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.	Up to 8 weeks post-intervention
Secondary	Perceived Utility Ratings	Participants were asked to rate three items relating to the perceived utility of each module. Specifically, we asked participants: How helpful the module was How engaging the module was How much they will continue applying content from the module. Higher scores indicate greater perceived utility.	Immediately after the intervention
Secondary	Change in the Perceived Stress Scale-4	Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.	Up to 8 weeks post-intervention
Secondary	Change in the Gratitude Adjective Checklist	Gratitude measure. Three items rated on a 1-5 scale with total scores ranging from 3-15. Higher scores indicate higher levels of gratitude.	Up to 8 weeks post-intervention
Secondary	Change in the Self-kindness subscale of the Self-Compassion Scale	Self-compassion measure. We are using the 5-item self-kindness subscale. Participants will provide values ranging from 1 to 5. These values will be summed to create a total score on this scale ranging from 5 to 25, with higher scores representing higher levels of self-compassion.	Up to 8 weeks post-intervention
Secondary	Change in Cognitive Restructuring	We administered three items to assess cognitive restructuring, derived from the cognitive reappraisal subscale of the Emotion Regulation Questionnaire. Scores range from 3-21, with higher scores representing a higher amount of cognitive restructuring.	Up to 8 weeks post-intervention
Secondary	Change in items from the Behavioral Activation for Depression Scale	Behavioral Activation Measure. We selected 3 items from the BADS to use to assess changes in behavioral activation. The scores for these three items are summed to give a total score from 0-18. Higher scores represent higher levels of behavioral activation.	Up to 8 weeks post-intervention
Secondary	Beck Hopelessness Scale	Hopelessness Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (more hopelessness).	Up to 8 weeks post-intervention
Secondary	Change in module-specific skills	We are administering 4 items designed to detect cognitive or behavioral changes that relate to each intervention module.; Cognitive restructuring: "Over the past two weeks, I have been able to manage negative thoughts."; Behavior activation: "Over the past two weeks, I have intentionally spent time performing hobbies and activities that make me happy."; Gratitude: "Over the past two weeks, I have been able to focus my attention toward noticing and appreciating good things."; Self-compassion: "Over the past two weeks, I have been able to treat myself with empathy and compassion."; For each item, participants respond using a 7-point scale ranging from strongly disagree to strongly agree. Higher scores indicate favorable cognitions and behaviors related to each construct.	Up to 8 weeks post-intervention