Clinical trial NCT04949061: The Effectiveness of Culturally Adapted Cognitive Behavioral Intervention Among COVID-19 Survivors
Official title: Culturally Adapted Cognitive Behavioral Intervention to Reduce Psychological Distress Among COVID-19 Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Quality of Life
Depressive Symptoms
Anxiety
Keywords: COVID-19
COVID-19 survivors
Psychological distress
Online intervention
Quality of life
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Secondary outcomes:
measure: Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (PCL-5) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the Symptom Checklist 90-R (SCL-90-R) Somatization Subscale over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the World Health Organization Quality of Life Scale (WHOQOL Bref) over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Other outcomes:
measure: Comparison of changes of the Psychological Flexibility Scale over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
measure: Comparison of changes of the Emotion Regulation Questionnaire over time
timeFrame: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Talya Öztürk, BA
role: STUDY_CHAIR
References:
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