NCT04982523

Brief Summary

Late adolescence and early adulthood are the most exposed to trauma. College students exposed to trauma may experience depression, anxiety, stress, and difficulties adapting to college life. Depression symptoms are the most common reactions that people experience after traumatic experiences. Depression also harms college students reactions that people experience after traumatic experiences. It is difficult for people who are depressed to meet their social function. Trauma also has adverse physical effects, including dysfunction of the hypothalamus and adrenal axis, lowering blood cortisol levels. As a result, the body's immune system is disturbed, leaving people more exposed to diseases and experiencing more pain and fatigue. In particular, women are more vulnerable to PTSD than men. Women with post-traumatic stress and depression are also more likely to be exposed to several diseases. Moreover, when traumatized female college students experience life stress, it worsens their mental health and interferes with their studies. Cognitive behavioral therapy is the most effective content composition method for trauma intervention. CBT should be improved by helping to reduce PTSS and depression and managing various aspects of life, such as nutrition, activity, and rest. One major advantage of online programs is that they do not face any time or space constraints, and they are also less expensive than face-to-face programs. More importantly, online programs can reduce psychological barriers to participation. This is especially important for women who are more likely to feel shame and stigma about interpersonal traumas, such as those arising from relationships and sexual trauma, which are obstacles to their access to face-to-face programs. College students can easily access online programs because of their familiarity with the Internet, so the programs can be immediately available in response to crises without requiring them to expose personal information to unfamiliar therapists. In this study, the interventions program was based on the Roy Adaptation Model to address post-traumatic physical and mental health problems among female college students in Korea. Hypothesis

  • The post-traumatic stress scores, depressive symptom scores of participants who access the program will decrease more than those who do not.
  • The functional health scores, college adaptation scores of participants who access the program will increase more than those who do not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 21, 2021

Last Update Submit

July 22, 2021

Conditions

Keywords

Stress Disorders, Post-TraumaticDepressionInternet-Based InterventionCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change of post-traumatic stress symptoms

    Impact of Event Scale-Revised-Korean(IES-R-K). Version for Korean was measured the post traumatic stress symptom of female college students pre-test, post-test 1,2. The total score is 0 \~ 88 points, and the higher the total score, the more severe the post-traumatic stress symptoms.

    Baseline, 4 weeks, 8weeks

Secondary Outcomes (3)

  • Change of depression

    Baseline, 4 weeks, 8weeks

  • Fuctional Health

    Baseline, 4 weeks, 8weeks

  • College to adaptation

    Baseline, 4 weeks, 8weeks

Study Arms (2)

Online Mental Health Program Group

EXPERIMENTAL

The online mental health program of 8 sessions is provided. Data collection was collected pre-, post-, and one month after the program.

Behavioral: Online Mental Health Program

Control Group

NO INTERVENTION

Data collection was collected three times for three months. No intervention was provided during the study. If they wanted, they were provided the online mental health program same as the experimental group after data collection.

Interventions

The proposed program consisted of eight sessions conducted twice per week, consisting of 5 minutes of introductory material, 12-15 minutes of main content, and 5 minutes of concluding content. The main content intended to improve the control processes and each of the four adaptive modes of the RAM. The eight sessions were uploaded on the web. Links and passwords for each session were provided to the participants through SNS. The program was accessible from any electronic device with Internet access

Online Mental Health Program Group

Eligibility Criteria

Age19 Years - 29 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMale and female's cognition of trauma is different, and women are vulnerable to post-traumatic stress.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female college students between 19 and 29 years
  • who had a traumatic experience
  • who had post-traumatic stress symptom scores of 22-66

You may not qualify if:

  • who experienced childhood sexual abuse
  • who had experienced violent conflict or war, including North Korea defectors
  • who had a post-traumatic stress score greater than 66 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA University

Pocheon-si, Gyeonggi-do, 1160, South Korea

Location

Related Publications (15)

  • Breslau N, Kessler RC, Chilcoat HD, Schultz LR, Davis GC, Andreski P. Trauma and posttraumatic stress disorder in the community: the 1996 Detroit Area Survey of Trauma. Arch Gen Psychiatry. 1998 Jul;55(7):626-32. doi: 10.1001/archpsyc.55.7.626.

    PMID: 9672053BACKGROUND
  • Boyraz G, Horne SG, Owens AC, Armstrong AP. Academic achievement and college persistence of African American students with trauma exposure. J Couns Psychol. 2013 Oct;60(4):582-92. doi: 10.1037/a0033672. Epub 2013 Aug 19.

    PMID: 23957769BACKGROUND
  • Kim SH, Schneider SM, Bevans M, Kravitz L, Mermier C, Qualls C, Burge MR. PTSD symptom reduction with mindfulness-based stretching and deep breathing exercise: randomized controlled clinical trial of efficacy. J Clin Endocrinol Metab. 2013 Jul;98(7):2984-92. doi: 10.1210/jc.2012-3742. Epub 2013 May 29.

    PMID: 23720785BACKGROUND
  • Knaevelsrud C, Brand J, Lange A, Ruwaard J, Wagner B. Web-based psychotherapy for posttraumatic stress disorder in war-traumatized Arab patients: randomized controlled trial. J Med Internet Res. 2015 Mar 20;17(3):e71. doi: 10.2196/jmir.3582.

    PMID: 25799024BACKGROUND
  • Liu H, Petukhova MV, Sampson NA, Aguilar-Gaxiola S, Alonso J, Andrade LH, Bromet EJ, de Girolamo G, Haro JM, Hinkov H, Kawakami N, Koenen KC, Kovess-Masfety V, Lee S, Medina-Mora ME, Navarro-Mateu F, O'Neill S, Piazza M, Posada-Villa J, Scott KM, Shahly V, Stein DJ, Ten Have M, Torres Y, Gureje O, Zaslavsky AM, Kessler RC; World Health Organization World Mental Health Survey Collaborators. Association of DSM-IV Posttraumatic Stress Disorder With Traumatic Experience Type and History in the World Health Organization World Mental Health Surveys. JAMA Psychiatry. 2017 Mar 1;74(3):270-281. doi: 10.1001/jamapsychiatry.2016.3783.

    PMID: 28055082BACKGROUND
  • Shipherd JC, Clum G, Suvak M, Resick PA. Treatment-related reductions in PTSD and changes in physical health symptoms in women. J Behav Med. 2014 Jun;37(3):423-33. doi: 10.1007/s10865-013-9500-2. Epub 2013 Mar 8.

    PMID: 23471544BACKGROUND
  • Nayback AM. PTSD in the combat veteran: using Roy's Adaptation Model to examine the combat veteran as a human adaptive system. Issues Ment Health Nurs. 2009 May;30(5):304-10. doi: 10.1080/01612840902754404.

    PMID: 19437249BACKGROUND
  • Nguyen-Feng VN, Greer CS, Frazier P. Using online interventions to deliver college student mental health resources: Evidence from randomized clinical trials. Psychol Serv. 2017 Nov;14(4):481-489. doi: 10.1037/ser0000154.

    PMID: 29120206BACKGROUND
  • Roberts AL, Kubzansky LD, Chibnik LB, Rimm EB, Koenen KC. Association of Posttraumatic Stress and Depressive Symptoms With Mortality in Women. JAMA Netw Open. 2020 Dec 1;3(12):e2027935. doi: 10.1001/jamanetworkopen.2020.27935.

    PMID: 33275156BACKGROUND
  • Woods SJ, Isenberg MA. Adaptation as a mediator of intimate abuse and traumatic stress in battered women. Nurs Sci Q. 2001 Jul;14(3):215-21. doi: 10.1177/08943180122108463.

    PMID: 11873342BACKGROUND
  • Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. doi: 10.1056/NEJMra012941. No abstract available.

    PMID: 11784878BACKGROUND
  • Seo, Y. S., Jo, H. J., An, H. Y., & Lee, J. S. (2012). Traumatic Events Experenced by South Koreans: Types and Prevalence. Korean journal of counseling and psychotherapy, 24(3), 671-701.

    BACKGROUND
  • Lee, D., Kim, J., & Kim, J. J. (2015). An Exploratory Study on the Possibilities and Limitations of Online Psychotherapy. The Korean Journal of Counseling and Psychotherapy, 27(3), 543-582., Corpus ID: 197667819

    BACKGROUND
  • Lee, K., Jo, H., & Kim, S. (2018). Relationships among Traumatic Experiences, Posttraumatic Stress Symptoms, and Mental Health-related Characteristics in Young Adults. Journal of Korean Academy of Psychiatric and Mental Health Nursing, 27(2), 85. https://doi.org/10.12934/jkpmhn.2018.27.2.85

    BACKGROUND
  • Shin, J., Lee, D.-H., Lee, S.-Y., & Han, Y.-S. (2015). A study on types of traumatic events experienced by undergraduate students. The Journal of Play Therapy, 19(2), 69-95.

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kyunghyun Lee, Ph. D

    CHA University

    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
Assistant professor

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 29, 2021

Study Start

April 27, 2020

Primary Completion

November 30, 2020

Study Completion

December 3, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations