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

September 6, 2023 updated by: Koç University

Effectiveness of a Culturally Adapted Cognitive Behavioral Intervention to Reducing Psychological Distress and Improving Well-Being Among University Students During the COVID-19 Pandemic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Koç University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]
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.
Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Study Chair: Ekin Çakır, PhD Student, Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2021

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

August 15, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.465.IRB3.184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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