- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759313
Image Narrative With College Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AIM 1. To understand the unique experiences of emerging adult college students during the Covid-19 pandemic (especially around the themes of the self, relationships with others, and the future).
AIM 2. To evaluate the feasibility of the INI for emerging adult college students during the Covid-19 pandemic, both quantitatively and qualitatively.
AIM 3. To evaluate the preliminary efficacy of the INI on distress, PTG, Quality of Life and Meaning-Making.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaehee Yi, PhD
- Phone Number: 8016947348
- Email: jaehee.yi@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-29 in age
- college students at the University of Utah
- reporting moderate or higher levels of distress in DASS21
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Imagenarrative treatment group
INI Sessions: Each participant will take part in a 5-week program of weekly 1-hour telehealth sessions with the PI or a social work PhD student facilitator trained in the INI by the PI.
|
Each participant will take part in a 5-week program of weekly 1-hour telehealth sessions with the PI or a social work PhD student facilitator trained in the INI by the PI.
|
|
Experimental: Wait List Control Group
In weeks 6 through 10, the same program will be delivered to the wait list control group.
|
Each participant will take part in a 5-week program of weekly 1-hour telehealth sessions with the PI or a social work PhD student facilitator trained in the INI by the PI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DASS (Depression, Anxiety and Stress Scale) 21
Time Frame: change through study completion, an average of 3 months
|
measuring distress
|
change through study completion, an average of 3 months
|
|
PTGI (posttraumatic growth index)
Time Frame: change through study completion, an average of 3 months
|
measuring posttraumatic growth
|
change through study completion, an average of 3 months
|
|
WHOQOL (WHO quality of life)-bref
Time Frame: change through study completion, an average of 3 months
|
measuring quality of life
|
change through study completion, an average of 3 months
|
|
MLQ (meaning in life)
Time Frame: change through study completion, an average of 3 months
|
measuring meaning making
|
change through study completion, an average of 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaehee Yi, PhD, University of Utah
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- imagenarrative
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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