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

NCT04858789 | Completed DMC

• 1 other identifier: 2020.465.IRB3.184
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Well-being

Keywords

Culturally adapted; Covid-19; Psychological distress; University students; Well-being; Online intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time

  Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]

• Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time

  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

  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

  Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)

Other Outcomes (3)

• Comparison of changes of the Dispositional Hope Scale over time

  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

  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

  Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)

Study Arms (2)

Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)

EXPERIMENTAL

The experimental group will receive an 8-session CA-CBI in an online group format.

Behavioral: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)

Control

NO INTERVENTION

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.

Interventions

Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) BEHAVIORAL

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.

Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 16382423 BACKGROUND

• 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.

  PMID: 15633922 BACKGROUND

• 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.

  PMID: 30300732 BACKGROUND

• 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.

  PMID: 32485289 BACKGROUND

• 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.

  PMID: 29215315 BACKGROUND

• 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.

  PMID: 32229390 BACKGROUND

• 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.

  PMID: 29345479 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ekin Çakır, PhD Student

  Koç University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: June 24, 2021
• Primary Completion: July 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)