Clinical trial NCT04858789: The Effectiveness of a CA-CBI on Psychological Distress of University Students During the COVID-19 Pandemic
Official title: Effectiveness of a Culturally Adapted Cognitive Behavioral Intervention to Reducing Psychological Distress and Improving Well-Being Among University Students During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Well-being
Keywords: Culturally adapted
Covid-19
Psychological distress
University students
Well-being
Online intervention
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effectiveness study for Culturally Adapted Cognitive Behavioral Intervention will be conducted with university students to measure if this intervention if effective for decreasing the university students' psychological distress and increase their well-being during the COVID-19 pandemic. Potential participants will be given an informed consent and included in a screening procedure to decide their eligibility. 100 participants (50 in experimental and 50 in control group-randomly assigned) who pass the screening procedure will be invited to the effectiveness study. The experimental group will receive an 8-session intervention while the control group will receive information about the freely available psychological support options. The measurements will be conducted three times; one week before, one week after and five weeks after the intervention.

Detailed description: Rapid increase in the COVID-19 cases and COVID-19 related deaths were followed by several precautions including the daily usage of masks, social distancing, temporary closure of work places, government departments, schools and universities. Due to these adversities and necessary precautions, people experience psychological distress and symptoms of depression and anxiety during the pandemic. Research shows that university students are at risk for developing psychological distress and common mental health disorder symptoms, and providing psychological interventions for university students may decrease the mental health problems of the students. However, considering the social distancing, these interventions must be delivered online. There are some studies indicate that online interventions may be effective as face-to-face interventions. Considering the mental health support need that the university students have during COVID-19, addressing this need may be beneficial for the mental health of university students in these uncertain times. There are various studies that showed the effectiveness of various form of interventions and one of them is Culturally Adapted Cognitive Behavioral (CA-CB) intervention developed by Hinton. CA-CB interventions were tested with adolescents and women in Turkey and found to decrease the psychological symptoms of these people. CA-CB interventions are based on the cognitive behavioral approach's principles but also include emotion regulation techniques, mindfulness and stretching exercises.

The investigators propose to conduct a randomized controlled trial in which they aim to apply a preventive culturally adapted cognitive behavioral intervention (CA-CBI) which is adapted to university students and COVID-19 related stressors. After the adaptation process is completed, the investigators will distribute an online survey to university students for the recruitment. The university students who would like to participate in the intervention study and are eligible to participate will be included. The investigators will randomly assign them into two arms (control and CA-CBI) and then deliver CA-CBI in a group format to the intervention arm. The investigators will examine whether the psychological distress levels and common mental health problems of the students in the intervention arm is decreased compared to the control arm. The investigators will examine the study outcomes of the both arms at three times: Pre-assessment (1 week before the intervention), post-assessment (1 week after the intervention) and follow-up assessment (1 month after the post-assessment). A process evaluation according to the WHO will be completed with 5 study completers, 5 drop-outs and 2 facilitators to evaluate the feasibility of delivering CA-CBI.

Although the CA-CBI was delivered in Turkey to different populations before, it was not tested with university students yet. In addition, there are scarce publications on the online delivered group interventions and to our knowledge, there is neither such research conducted during the pandemic nor research about the efficacy of online synchronous interventions in Turkey. The investigators will contribute to the literature by adapting CA-CBI to the university students who are affected from COVID-19. In addition, they will also add to the literature on online interventions by delivering CA-CBI online in a group format.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or above
* Being a university student
* Scoring 16 or above on Kessler Psychological Distress Scale (K10)
* Scoring 14 or belove on Patient Health Questionnaire-9 (PHQ-9)

Exclusion Criteria:

* Being older than 30 years
* Imminent suicidal risk
* Living outside of Turkey
* Having any type of psychiatric disorder
* Receiving any specialized psychological or psychiatric treatment at the time of application to the study

Primary outcomes:
measure: Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
Secondary outcomes:
measure: Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
measure: Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the World Health Organization (Five) Well-Being Index (WHO-5) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Other outcomes:
measure: Comparison of changes of the Dispositional Hope Scale over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
measure: Comparison of changes of the Emotion Regulation Questionnaire over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
measure: 8. Comparison of changes of the Acceptance and Action Questionnaire-II (AAQ-II) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Ekin Çakır, PhD Student
role: STUDY_CHAIR
References:
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citation: Acarturk ZC, Abuhamdeh S, Jalal B, Unaldi N, Alyanak B, Cetinkaya M, Gulen B, Hinton D. Culturally adapted transdiagnostic CBT for SSRI resistant Turkish adolescents: A pilot study. Am J Orthopsychiatry. 2019;89(2):222-227. doi: 10.1037/ort0000310. Epub 2018 Jan 18.