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

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ClinicalTrials.gov Identifier: NCT04858789
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Koç University

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.

Condition or disease Intervention/treatment Phase
Psychological Distress Well-being Behavioral: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: College Health

Arm Intervention/treatment
Experimental: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)
The experimental group will receive an 8-session CA-CBI in an online group format.
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.

No Intervention: Control
The control (care as usual) group will receive the information about freely available psychological support options. After all the measurements are completed, the control group will be able to receive CA-CBI, too.



Primary Outcome Measures :
  1. Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)] ]
    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.


Secondary Outcome Measures :
  1. Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)] ]
    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.

  2. Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment) ]
    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

  3. Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment) ]
    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.

  4. Comparison of changes of the World Health Organization (Five) Well-Being Index (WHO-5) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment) ]
    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.


Other Outcome Measures:
  1. Comparison of changes of the Dispositional Hope Scale over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)] ]
    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.

  2. Comparison of changes of the Emotion Regulation Questionnaire over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)] ]
    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.

  3. 8. Comparison of changes of the Acceptance and Action Questionnaire-II (AAQ-II) over time [ Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858789


Contacts
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Contact: Ceren Acartürk, Assoc. Prof. 90 212 338 ext 1043 cacarturk@ku.edu.tr

Locations
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Turkey
Koc University Recruiting
Istanbul, Turkey
Contact: Ceren Acarturk, Assoc. Prof.         
Sponsors and Collaborators
Koç University
Investigators
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Study Chair: Ekin Çakır, PhD Student Koç University
  Study Documents (Full-Text)

Documents provided by Koç University:
Study Protocol  [PDF] March 21, 2021
Informed Consent Form  [PDF] March 21, 2021

Publications:

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Responsible Party: Koç University
ClinicalTrials.gov Identifier: NCT04858789    
Other Study ID Numbers: 2020.465.IRB3.184
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koç University:
Culturally adapted
Covid-19
Psychological distress
University students
Well-being
Online intervention
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases