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

NCT04949061 | Completed DMC

• 1 other identifier: 2021.265.IRB1.091
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Quality of Life; Depressive Symptoms; Anxiety

Keywords

COVID-19; COVID-19 survivors; Psychological distress; Online intervention; Quality of life

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 (5)

• 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 Symptom Checklist 90-R (SCL-90-R) Somatization Subscale 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 Quality of Life Scale (WHOQOL Bref) over time

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

Other Outcomes (2)

• Comparison of changes of the Psychological Flexibility 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)

Study Arms (2)

Intervention Arm: 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 Arm: Enhanced Treatment as Usual (ETA-U)

OTHER

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)

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 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.

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

Enhanced Treatment as Usual (ETA-U) OTHER

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.

Control Arm: Enhanced Treatment as Usual (ETA-U)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Luo M, Guo L, Yu M, Jiang W, Wang H. The psychological and mental impact of coronavirus disease 2019 (COVID-19) on medical staff and general public - A systematic review and meta-analysis. Psychiatry Res. 2020 Sep;291:113190. doi: 10.1016/j.psychres.2020.113190. Epub 2020 Jun 7.

  PMID: 32563745 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

• Kananian S, Soltani Y, Hinton D, Stangier U. Culturally Adapted Cognitive Behavioral Therapy Plus Problem Management (CA-CBT+) With Afghan Refugees: A Randomized Controlled Pilot Study. J Trauma Stress. 2020 Dec;33(6):928-938. doi: 10.1002/jts.22615. Epub 2020 Nov 5.

  PMID: 33155348 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

• Yue JL, Yan W, Sun YK, Yuan K, Su SZ, Han Y, Ravindran AV, Kosten T, Everall I, Davey CG, Bullmore E, Kawakami N, Barbui C, Thornicroft G, Lund C, Lin X, Liu L, Shi L, Shi J, Ran MS, Bao YP, Lu L. Mental health services for infectious disease outbreaks including COVID-19: a rapid systematic review. Psychol Med. 2020 Nov;50(15):2498-2513. doi: 10.1017/S0033291720003888. Epub 2020 Nov 5.

  PMID: 33148347 BACKGROUND

• Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.

  PMID: 33836148 BACKGROUND

• Wang Y, Kala MP, Jafar TH. Factors associated with psychological distress during the coronavirus disease 2019 (COVID-19) pandemic on the predominantly general population: A systematic review and meta-analysis. PLoS One. 2020 Dec 28;15(12):e0244630. doi: 10.1371/journal.pone.0244630. eCollection 2020.

  PMID: 33370404 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; 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

• Talya Öztürk, BA

  Koç University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 2, 2021
• Study Start: November 17, 2021
• Primary Completion: March 28, 2022
• Study Completion: April 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)