Clinical trial NCT04982523: Online Mental Health Program for Female College Students
Official title: Development and Evaluation of an Online Mental Health Program for Traumatized Female College Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Stress Disorders, Post-Traumatic
Depression
Internet-Based Intervention
Cognitive Behavioral Therapy
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 34
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change of post-traumatic stress symptoms
timeFrame: Baseline, 4 weeks, 8weeks
Secondary outcomes:
measure: Change of depression
timeFrame: Baseline, 4 weeks, 8weeks
measure: Fuctional Health
timeFrame: Baseline, 4 weeks, 8weeks
measure: College to adaptation
timeFrame: Baseline, 4 weeks, 8weeks
Other outcomes:
Locations:
city: Pocheon-si
country: Korea, Republic of
facility: CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Kyunghyun Lee, Ph. D
role: PRINCIPAL_INVESTIGATOR
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