The Effectiveness of Culturally Adapted Cognitive Behavioral Intervention Among COVID-19 Survivors

June 29, 2022 updated by: Koç University

Culturally Adapted Cognitive Behavioral Intervention to Reduce Psychological Distress Among COVID-19 Survivors: A Randomized Controlled Trial

The effectiveness study for Culturally-Adapted Cognitive Behavioral Intervention (CA-CBI) will be conducted with individuals infected with and recovered from Coronavirus disease (COVID-19) to measure if this intervention is effective in decreasing the COVID-19 survivors' psychological distress. Potential participants will be given an informed consent and then, they will be included in a screening procedure to assess their eligibility. 86 participants (43 in experimental and 43 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 a brief psychoeducation about problems during COVID-19 pandemic and 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

The COVID-19 pandemic has an enormous psychological impact worldwide. Individuals with suspected or confirmed COVID-19 have been defined as one of the most vulnerable groups suffering from psychological distress during the pandemic. Individuals who were infected with and recovered from COVID-19 had a significantly increased risk for developing psychiatric conditions such as anxiety and mood disorders, substance use disorders, and insomnia, even when comparing with individuals who had other respiratory tract infections. In addition, these psychiatric conditions remained elevated at the 6-month period for COVID-19 survivors. Therefore, COVID-19 survivors should be considered to be in need of an urgent intervention.

Considering the COVID-19 pandemic and future epidemics of other infectious diseases, more evidence-based psychosocial interventions should be implemented via online services. Group-based cognitive behavioral therapy (CBT) is one of the interventions identified as effective in decreasing adverse psychological outcomes of COVID-19 pandemic, as well as of Ebola and Severe acute respiratory syndrome (SARS). One of the forms of CBT is culturally adapted CBT (CA-CBT) developed by Hinton. CA-CBT is a trans-diagnostic method targeting cognitive and behavioral changes while emphasizing emotion regulation and psychological flexibility with some techniques such as mindfulness exercises, meditation, and applied stretching. In Turkey, CA-CBT was tested on adolescents and found to be effective in decreasing the adolescents' anxiety and depression symptoms.

The investigators propose to conduct a randomized controlled trial in order to implement culturally adapted cognitive behavioral intervention (CA-CBI) to COVID-19 survivors and evaluate the effectiveness of the intervention in reducing the psychological distress for this particular group. After the screening phase and baseline assessment, the investigators will randomly assign the eligible participants into two arms (CA-CBI and Enhanced Treatment as Usual) and deliver CA-CBI in an online group format to the experimental arm. The investigators will assess whether the psychological distress levels and common mental health problems of the COVID-19 survivors in the experimental arm are 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 World Health Organization (WHO) will be completed with 5 study completers, 5 drop-outs and 2 facilitators to evaluate the feasibility of delivering CA-CBI.

To the knowledge, CA-CBI has not been conducted with survivors of an infectious disease before. Also, there are scarce publications on mental health interventions implemented to COVID-19 survivors. There is a need for more evidence-based psychological interventions that can be applied to the times of COVID-19 pandemic and future epidemics of infectious diseases, especially for vulnerable groups. Therefore, the investigators will contribute to the literature by applying online-delivered group-based CA-CBI to COVID-19 survivors with increased levels of psychological distress.

Study Type

Interventional

Enrollment (Actual)

34

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Koc 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 18 years or above
  • Getting infected with COVID-19 and currently, recovered
  • Scoring 16 or above on Kessler Psychological Distress Scale (K10)

Exclusion Criteria:

  • Imminent suicidal risk
  • Having a severe psychiatric disorder (psychotic disorders, acute mania, substance/alcohol addiction, cluster B personality disorders)

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Arm: 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 trans-diagnostic intervention has a structured manual which can be culturally adapted and it will be used to decrease psychological distress and increase quality of life by targeting cognitive and behavioral changes.
OTHER: Control Arm: Enhanced Treatment as Usual (ETA-U)
The control group will receive the information about freely available psychological support options. Also, they will receive brief psychoeducation about the mental health problems and psychological distress via online leaflets. After all the measurements are completed, the control group will be able to receive the CA-CBI.
Other: Enhanced Treatment as Usual (ETA-U)
Participants who receive ETAU will be provided a brief psychoeducation via online leaflets and will be informed about centers where they can receive free psychosocial support.

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 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 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 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 Symptom Checklist 90-R (SCL-90-R) Somatization Subscale over time
Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
The SCL-90-R Somatization Subscale is a 12-item scale that measures somatic complaints based on self-report. Each item is scored from 0 (not at all) to 4 (extremely), providing a range between 0 and 48. Higher scores indicate higher levels of somatic complaints.
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 Quality of Life Scale (WHOQOL Bref) over time
Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
The WHOQOL Bref Scale is a 27-item questionnaire that assesses the quality of general health and life. It has four domains which are physical health, psychological health, social relationships, and environment. It also has questions about overall perceptions of life quality and general health. Each item is scored from 1 to 5 on a 5-point Likert scale. For each domain, the mean score is calculated, providing a range between 4 and 20. Each mean domain score is multiplied by 4 to transform the domain score into a scaled score. In each domain, higher scores indicate higher levels of quality of life.
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 Psychological Flexibility Scale over time
Time Frame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
The Psychological Flexibility Scale is a 28-item scale that aims to assess psychological flexibility. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), providing a range between 28 and 196. Higher scores indicate more frequent use of psychological flexibility in individuals.
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)

Collaborators and Investigators

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

Sponsor

Koç University

Investigators

  • Study Chair: Talya Öztürk, BA, Koc 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)

November 17, 2021

Primary Completion (ACTUAL)

March 28, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.265.IRB1.091

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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