Anxiety Clinical Trial
Official title:
Culturally Adapted Cognitive Behavioral Intervention to Reduce Psychological Distress Among COVID-19 Survivors: A Randomized Controlled Trial
Verified date | July 2021 |
Source | Koç University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | April 1, 2022 |
Est. primary completion date | March 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Koc University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Koç University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of changes of the Psychological Flexibility Scale over time | 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) | |
Other | Comparison of changes of the Emotion Regulation Questionnaire over time | 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) | |
Primary | 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 | Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time | 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) | |
Secondary | Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time | 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) | |
Secondary | Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (PCL-5) over time | 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) | |
Secondary | Comparison of changes of the Symptom Checklist 90-R (SCL-90-R) Somatization Subscale over time | 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) | |
Secondary | Comparison of changes of the World Health Organization Quality of Life Scale (WHOQOL Bref) over time | 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) |
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