The Effectiveness of a CA-CBI on Psychological Distress of University Students During the COVID-19 Pandemic

Psychological Distress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858789
• Other study ID #: 2020.465.IRB3.184
• Status: Completed
• Phase: N/A
• Start date: June 24, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2023
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Psychological Distress
• Well-being

Intervention

Behavioral:
• Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)
CA-CBI is an intervention based on Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) which was developed by Devon Hinton. This transdiagnostic intervention has a structured manual which can be culturally adapted and it will be used to decrease psychological distress and increase well-being by targeting cognitive and behavioral changes.

Locations

Country	Name	City	State
Turkey	Koc University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

Cao W, Fang Z, Hou G, Han M, Xu X, Dong J, Zheng J. The psychological impact of the COVID-19 epidemic on college students in China. Psychiatry Res. 2020 May;287:112934. doi: 10.1016/j.psychres.2020.112934. Epub 2020 Mar 20. — View Citation

Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7. — View Citation

Hinton DE, Chhean D, Pich V, Safren SA, Hofmann SG, Pollack MH. A randomized controlled trial of cognitive-behavior therapy for Cambodian refugees with treatment-resistant PTSD and panic attacks: a cross-over design. J Trauma Stress. 2005 Dec;18(6):617-29. doi: 10.1002/jts.20070. — View Citation

Hinton DE, Pham T, Tran M, Safren SA, Otto MW, Pollack MH. CBT for Vietnamese refugees with treatment-resistant PTSD and panic attacks: a pilot study. J Trauma Stress. 2004 Oct;17(5):429-33. doi: 10.1023/B:JOTS.0000048956.03529.fa. — View Citation

Huang J, Nigatu YT, Smail-Crevier R, Zhang X, Wang J. Interventions for common mental health problems among university and college students: A systematic review and meta-analysis of randomized controlled trials. J Psychiatr Res. 2018 Dec;107:1-10. doi: 10.1016/j.jpsychires.2018.09.018. Epub 2018 Sep 29. — View Citation

Vindegaard N, Benros ME. COVID-19 pandemic and mental health consequences: Systematic review of the current evidence. Brain Behav Immun. 2020 Oct;89:531-542. doi: 10.1016/j.bbi.2020.05.048. Epub 2020 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of changes of the Dispositional Hope Scale over time	The Dispositional Hope Scale is a 12-item questionnaire that aims to measure the dispositional hope. Each item is scored from 1 (definitely false) to 8 (definitely true) providing a range between 8 and 96. Higher scores indicate higher levels of dispositional hope.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
Other	Comparison of changes of the Emotion Regulation Questionnaire over time	The Emotion Regulation Questionnaire is a 10-item questionnaire that aims to measure individual differences in emotion regulation and its strategies. Each item is scored from 1 (strongly disagree) to 7 (strongly agree) providing a range between 10 and 70. It has two subscales which are re-appraisal and suppression. Higher scores indicate more frequent use of these strategies.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
Other	8. Comparison of changes of the Acceptance and Action Questionnaire-II (AAQ-II) over time	The Acceptance and Action Questionnaire-II is a 7-item questionnaire that aims to measure psychological flexibility. Each item is scored from 1 (never true) to 7 (always true) providing a range between 7 and 49. Higher scores indicate less psychological flexibility.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Primary	Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time	Kessler-10 Psychological Distress Scale is a 10-item scale that aims to measure the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) providing a range between 10 and 50. Higher scores indicate more severe psychological distress.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
Secondary	Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time	Patient Health Questionnaire is a 9-item questionnaire that aims to measure the depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 27. Higher scores indicate more severe depressive symptoms.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
Secondary	Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time	General Anxiety Disorder-7 is a 7-item questionnaire that aims to measure anxiety symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 21. Higher scores indicate higher levels of anxiety symptoms	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Secondary	Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time	The PTSD Checklist for DSM-5 is a 20-item questionnaire that assesses the symptoms of post-traumatic stress disorder. Each item is scored from 0 (not at all) to 4 (extremely) providing a range between 0 and 80. Higher scores indicate higher levels of PTSD symptoms.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Secondary	Comparison of changes of the World Health Organization (Five) Well-Being Index (WHO-5) over time	The World Health Organization (Five) Well-Being Index (WHO-5) is a 5-item questionnaire that aims to measure well-being. Each item is scored from 0 (at no time) to 5 (all of the time) providing a range between 0 and 25. Higher scores indicate better well-being.	Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)