Back to resultsImage Narrative With College Students
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image Narrative
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety focused on measuring depression, college students, posttraumatic growth, meaning making, quality of life
Eligibility Criteria
Inclusion Criteria:
- 18-29 in age
- college students at the University of Utah
- reporting moderate or higher levels of distress in DASS21
Exclusion Criteria:
-
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Imagenarrative treatment group
Wait List Control Group
Arm Description
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.
In weeks 6 through 10, the same program will be delivered to the wait list control group.
Outcomes
Primary Outcome Measures
DASS (Depression, Anxiety and Stress Scale) 21
measuring distress, 0-63, higher is worse
PTGI (posttraumatic growth index)
measuring posttraumatic growth, 0-105, higher is better
WHOQOL (WHO quality of life)-bref
measuring quality of life, 0-100, higher is better
MLQ (meaning in life)
measuring meaning making, 0-70, higher is better
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04759313
Brief Title
Image Narrative With College Students
Official Title
Image Narrative With College Students
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The PI developed the Image Narrative Intervention (INI) based on the research using visual images in which visual images and narratives were found to support trauma survivors in narrating their experiences and in meaning making. The proposed study is the first study to test the therapeutic effect of the INI program. The investigators propose to assess, both qualitatively and quantitatively, the feasibility and preliminary effect of the INI through a pilot randomized control trial (RCT) design with a wait list control.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
depression, college students, posttraumatic growth, meaning making, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imagenarrative treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
Experimental
Arm Description
In weeks 6 through 10, the same program will be delivered to the wait list control group.
Intervention Type
Behavioral
Intervention Name(s)
Image Narrative
Intervention Description
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.
Primary Outcome Measure Information:
Title
DASS (Depression, Anxiety and Stress Scale) 21
Description
measuring distress, 0-63, higher is worse
Time Frame
change through study completion, an average of 3 months
Title
PTGI (posttraumatic growth index)
Description
measuring posttraumatic growth, 0-105, higher is better
Time Frame
change through study completion, an average of 3 months
Title
WHOQOL (WHO quality of life)-bref
Description
measuring quality of life, 0-100, higher is better
Time Frame
change through study completion, an average of 3 months
Title
MLQ (meaning in life)
Description
measuring meaning making, 0-70, higher is better
Time Frame
change through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-29 in age
college students at the University of Utah
reporting moderate or higher levels of distress in DASS21
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaehee Yi, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Image Narrative With College Students
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