Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Image Narrative With College Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759313
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Jaehee Yi, University of Utah

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The PI developed the Image Narrative Intervention (INI) based on her research using visual images in which she found that visual images and narratives 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. We 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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: Image Narrative Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Narrative With College Students
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Behavioral: Image Narrative
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.
 Behavioral: Image Narrative
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. DASS (Depression, Anxiety and Stress Scale) 21 [ Time Frame: change through study completion, an average of 3 months ]
    measuring distress

  2. PTGI (posttraumatic growth index) [ Time Frame: change through study completion, an average of 3 months ]
    measuring posttraumatic growth

  3. WHOQOL (WHO quality of life)-bref [ Time Frame: change through study completion, an average of 3 months ]
    measuring quality of life

  4. MLQ (meaning in life) [ Time Frame: change through study completion, an average of 3 months ]
    measuring meaning making


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759313


Contacts
Layout table for location contacts
Contact: Jaehee Yi, PhD 8016947348 jaehee.yi@gmail.com

Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Jaehee Yi, PhD University of Utah
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jaehee Yi, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04759313    
Other Study ID Numbers: imagenarrative
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaehee Yi, University of Utah:
depression
college students
posttraumatic growth
meaning making
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms