NCT04759313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 10, 2021

Last Update Submit

February 1, 2023

Conditions

Depression, Anxiety

Keywords

depressioncollege studentsposttraumatic growthmeaning makingquality of life

Outcome Measures

Primary Outcomes (4)

  • DASS (Depression, Anxiety and Stress Scale) 21

    measuring distress, 0-63, higher is worse

    change through study completion, an average of 3 months

  • PTGI (posttraumatic growth index)

    measuring posttraumatic growth, 0-105, higher is better

    change through study completion, an average of 3 months

  • WHOQOL (WHO quality of life)-bref

    measuring quality of life, 0-100, higher is better

    change through study completion, an average of 3 months

  • MLQ (meaning in life)

    measuring meaning making, 0-70, higher is better

    change through study completion, an average of 3 months

Study Arms (2)

Imagenarrative treatment group

EXPERIMENTAL

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

Wait List Control Group

EXPERIMENTAL

In weeks 6 through 10, the same program will be delivered to the wait list control group.

Behavioral: Image Narrative

Interventions

Image NarrativeBEHAVIORAL

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.

Imagenarrative treatment groupWait List Control Group

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • in age
  • college students at the University of Utah
  • reporting moderate or higher levels of distress in DASS21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Jaehee Yi, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 18, 2021

Study Start

March 15, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)