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Online Wellness Intervention for College Students

Primary Purpose

Depression, Anxiety, Well-being

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Common Elements Toolbox (COMET)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Common Elements Toolbox (COMET)

Wait-list control condition

Arm Description

Outcomes

Primary Outcome Measures

Change in the Patient Health Questionnaire-9 (PHQ-9)
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change in the Perceived Stress Scale-4
Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
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.
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.
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.
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.
Beck Hopelessness Scale
Hopelessness Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (more hopelessness).
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.

Full Information

First Posted
February 1, 2021
Last Updated
May 11, 2021
Sponsor
University of Pennsylvania
Collaborators
Indiana University, Ohio State University, University of Missouri, St. Louis
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1. Study Identification

Unique Protocol Identification Number
NCT04740411
Brief Title
Online Wellness Intervention for College Students
Official Title
An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Indiana University, Ohio State University, University of Missouri, St. Louis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Common Elements Toolbox (COMET)
Arm Type
Experimental
Arm Title
Wait-list control condition
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
The Common Elements Toolbox (COMET)
Intervention Description
COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes.
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire-9 (PHQ-9)
Description
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Time Frame
Up to 8 weeks post-intervention
Title
Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
Description
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Time Frame
Up to 8 weeks post-intervention
Title
Change in the Short Warwick-Edinburgh Mental Well-being Scale
Description
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Time Frame
Up to 8 weeks post-intervention
Title
Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).
Description
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.
Time Frame
Up to 8 weeks post-intervention
Secondary Outcome Measure Information:
Title
Ratings on the Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Immediately after the intervention
Title
Ability to Cope with COVID-19
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Change in Secondary Control
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Change in the Positive and Negative Affect Schedule
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Perceived Utility Ratings
Description
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.
Time Frame
Immediately after the intervention
Title
Change in the Perceived Stress Scale-4
Description
Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
Time Frame
Up to 8 weeks post-intervention
Title
Change in the Gratitude Adjective Checklist
Description
Gratitude measure. Three items rated on a 1-5 scale with total scores ranging from 3-15. Higher scores indicate higher levels of gratitude.
Time Frame
Up to 8 weeks post-intervention
Title
Change in the Self-kindness subscale of the Self-Compassion Scale
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Change in Cognitive Restructuring
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Change in items from the Behavioral Activation for Depression Scale
Description
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.
Time Frame
Up to 8 weeks post-intervention
Title
Beck Hopelessness Scale
Description
Hopelessness Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (more hopelessness).
Time Frame
Up to 8 weeks post-intervention
Title
Change in module-specific skills
Description
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.
Time Frame
Up to 8 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akash Wasil, MA
Phone
631-766-9466
Email
wasil@sas.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akash Wasil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Online Wellness Intervention for College Students

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