Psychological DistressNCT04949061
The Effectiveness of Culturally Adapted Cognitive Behavioral Intervention Among COVID-19 Survivors
A study testing Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) and Enhanced Treatment as Usual (ETA-U) in people with Psychological Distress and Quality of Life, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Quality of Life, Depressive Symptoms
- What is being tested?
- Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) and Enhanced Treatment as Usual (ETA-U)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or above
- Getting infected with COVID-19 and currently, recovered
- Scoring 16 or above on Kessler Psychological Distress Scale (K10)
Who cannot join
- Imminent suicidal risk
- Having a severe psychiatric disorder (psychotic disorders, acute mania, substance/alcohol addiction, cluster B personality disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Distress, Quality of Life, Depressive Symptoms, Anxiety
- Being tested
- Culturally Adapted Cognitive Behavioral Intervention (CA-CBI), Enhanced Treatment as Usual (ETA-U)
- Keywords
- COVID-19, COVID-19 survivors, Psychological distress, Online intervention, Quality of life
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)Behavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Treatment as Usual (ETA-U) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start17 Nov 2021
- Primary completion28 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Talya Öztürk, BA, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949061
- Sponsor's protocol ID
- 2021.265.IRB1.091
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32563745Acarturk 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.
PubMed 29345479Kananian 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.
PubMed 33155348Hinton 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.
PubMed 15633922Yue 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.
PubMed 33148347Taquet 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.
PubMed 33836148Wang 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.
PubMed 33370404
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavioral Intervention to Reduce Psychological Distress Among COVID-19 Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04949061
- Acronym / sponsor ID
- 2021.265.IRB1.091
- Conditions
- Psychological Distress, Quality of Life, Depressive Symptoms, Anxiety
- Keywords
- COVID-19, COVID-19 survivors, Psychological distress, Online intervention, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) | Experimental | Behavioral: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)The experimental group will receive an 8-session CA-CBI in an online group format. |
| Control Arm: Enhanced Treatment as Usual (ETA-U) | Other | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years or above
- Getting infected with COVID-19 and currently, recovered
- Scoring 16 or above on Kessler Psychological Distress Scale (K10)
Key exclusion criteria (2 listed)
- Imminent suicidal risk
- Having a severe psychiatric disorder (psychotic disorders, acute mania, substance/alcohol addiction, cluster B personality disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Arm: Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) |
| 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. | Other | Control Arm: Enhanced Treatment as Usual (ETA-U) |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 32563745Luo 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.
- Background: PubMed 29345479Acarturk 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.
- Background: PubMed 33155348Kananian 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.
- Background: PubMed 15633922Hinton 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.
- Background: PubMed 33148347Yue 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.
- Background: PubMed 33836148Taquet 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.
- Background: PubMed 33370404Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talya Öztürk, BA study chair
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Cognitive Behavioral Intervention (CA-CBI) and Enhanced Treatment as Usual (ETA-U) in people with Psychological Distress and Quality of Life, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949061, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.