Online Mental Health Program for Female College Students

Post Traumatic Stress Disorder Clinical Trial

Official title:

Development and Evaluation of an Online Mental Health Program for Traumatized Female College Students: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982523
• Other study ID #: Nursing001
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: December 3, 2020

Study information

• Verified date: July 2021
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. Study Design This study used a randomized control group pretest-posttest design to verify the effectiveness of the proposed program. 2. Participants & Recruitment Initial participants were recruited from eight universities in Korea through advertisements on SNS and bulletin boards at the university. Applicants indicated their interest in the study by contacting the research director via SNS, email, or SMS. The research director sent a reply message with the research information and an initial screening survey link. The applicants were initially screened for post-traumatic stress and depression. For inclusion, the participants had to be female college students between 19 and 29 years with a traumatic experience and post-traumatic stress symptom scores of 22-66, which is a cutoff that can be diagnosed as post-traumatic stress disorder; anything above 66 is a severe post-traumatic stress disorder condition that cannot be suitably addressed in this study (Eun, 2005; Lee et al., 2018). The following participants were excluded: those who experienced childhood sexual abuse; those who had experienced violent conflict or war, including North Korean defectors; and those who had a post-traumatic stress score greater than 66 points. According to a prior study, those who experienced childhood sexual abuse, war, or civil war are at a higher risk of suicide attempts. Therefore, they were excluded because their profiles did not match the purpose of this study (Hirai & Clum, 2005). The number of subjects for this study was calculated by G × power using a calculating power of 0.8 for the replicate measurement variance analysis, a medium effect size of 0.25, and a significance level of .05 (Cohen, 1988), resulting in a total of 28 people. Fifty-eight people will be recruited, taking into account the dropout rate of 30%. 3. Procedure The experimental group's pre- and post-outcome measures were collected at pre-treatment, post-treatment, and 1-month follow-up. Data were collected from the control group three times for three months. After the three surveys, the control group was provided the same program as the experimental group if the participants chose to join. All questionnaires were conducted using Google Survey. 4. 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 introduction included a brief exercise since exercises can relieve post-traumatic stress symptoms by changing the body's cortisol concentrations (Kim et al., 2013). The main content intended to improve the control processes and each of the four adaptive modes of the Roy Adaptation Model. No session lasted longer than 25 min. Participants are given homework and feedback through SNSs. The program's sessions were accessible through blog entries posted on https://www.tistory.com. Every post in the blog required a password. Links and passwords for each session were provided to the participants through SNS. The program was accessible from any electronic device with Internet access, including computers and smartphones, and was strictly accessible through links provided by the researchers. The program was partially revised considering the topics' practicality after a feasibility study and consultation with experts. 5. Measurements 1) Trauma experience: Stress Life Events Screening Questionnaire 2) Post-traumatic stress symptoms: Impact of Event Scale-Revised 3) Depression: Center for Epidemiological Studies Depression Scale 4) Functional health: Functional Health Pattern Assessment Screening Tool 5) Adaptation to college life: Students Adjustment to College Questionnaire

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 3, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 29 Years

Eligibility

Inclusion Criteria:

1. female college students between 19 and 29 years

2. who had a traumatic experience

3. who had post-traumatic stress symptom scores of 22-66

Exclusion Criteria:

1. who experienced childhood sexual abuse

2. who had experienced violent conflict or war, including North Korea defectors

3. who had a post-traumatic stress score greater than 66 points

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Online Mental Health Program
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

Locations

Country	Name	City	State
Korea, Republic of	CHA University	Pocheon-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. Erratum in: JAMA Psychiatry. 2017 Jul 1;74(7):764. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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.

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.

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. — View Citation

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. — View Citation

Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of depression	Change of depression : Center of Epidemiological Studies Depression Scale (CES-D) Korean version was measured the depression of female college students pre-test, post test 1,2. The total score is 0 ~ 60, and the higher the total score, the more depressed it is.	Baseline, 4 weeks, 8weeks
Secondary	Fuctional Health	Functional Health : Functional Health Pattern Assessment Screening Tool (FHPAST) Korean version was measured the functional health of female college students pre-test, post-test 1,2. It consists of a four-point scale (1-4 points), and the higher the score, the better the health function level.	Baseline, 4 weeks, 8weeks
Secondary	College to adaptation	College to adaptation : Students Adaptation to College Questionnaire (SACQ). Korean Version was measured the adaptation of college students pre-test, post- test 1,2. It consists of a 9-point scale (1 to 9 points), and the higher the score, the better the adaptation to college life.	Baseline, 4 weeks, 8weeks