Psychological DistressCARED-ACTNCT06189937
Group CA-CBT Intervention to Reduce Psychological Distress of Earthquake Survivors
A study testing Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) in people with Psychological Distress and Depressive Symptoms, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Earthquakes in Türkiye cause survivors to develop serious and prolonged mental health issues and adapted versions of cognitive behavioral therapy has proven to be successful in addressing these concerns.The main goal of this pilot randomized control trial (RCT) is to test potential effectiveness of Culturally Adapted… 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, Depressive Symptoms, Well-Being, Psychological
- What is being tested?
- Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Jan 2025
- 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 old or older.
- Having experienced the earthquake.
- Having a considerable amount of psychological distress: scoring 16 or higher on the Kessler Psychological Distress Scale (K10).
Who cannot join
- Having a severe mental disorder (conducted by a trained assessor).
- Presenting suicidality (assessed by the Problem Management Plus Suicidality Tool).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Adapted Cognitive Behavioral Therapy to Reduce Psychological Distress of Individuals Affected by the Earthquake: A Pilot Randomized Controlled Trial
Earthquakes in Türkiye cause survivors to develop serious and prolonged mental health issues and adapted versions of cognitive behavioral therapy has proven to be successful in addressing these concerns.The main goal of this pilot randomized control trial (RCT) is to test potential effectiveness of Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) in reducing psychological distress and depressive symptoms and increasing well-being of earthquake survivors.
Read the detailed description
Türkiye was struck by two large earthquakes with moment magnitudes 7.7. and 7.6, on the 6th of February 2023. The disaster resulted in more than 50 thousand people losing their lives, more than 107 thousand people getting injured and more than 84 thousand buildings being demolished, severely damaged or slated for demolition. After the earthquakes, various mental health issues can emerge among the survivors such as depression, anxiety disorders, posttraumatic stress disorder, sleep problems, prolonged grief disorder, decrease in quality of life, increase in suicidality and substance use, and their effects can be prolonged if not treated.
An effective treatment method for the mental health issues that the earthquake survivors may experience is cognitive behavioral therapy (CBT) which is effective both in individual and group formats. Moreover, culturally adapted versions of CBT demonstrated higher effectiveness. One such adaptation, developed as a transdiagnostic intervention by Devon Hinton, is known as Culturally Adapted CBT (CA-CBT), which has shown effectiveness across various cultures and countries. It has been successfully applied to depressed and traumatized women in Türkiye, reducing depressive symptoms and PTSD. CA-CBT incorporates emotion regulation techniques, mindfulness and stretching exercises as well as cognitive-behavioral approach principles. Some advantages of the CA-CBT are: (1) as a transdiagnostic intervention, it can be applied to treat various psychopathologies (2) as a group intervention, it can be applied to multiple individuals simultaneously, (3) as an 8-session intervention, it can improve mental health in the short term.
CA-CBT has not been tested with a population specifically consisting of individuals affected by earthquakes before. This pilot randomized control trial (RCT) aims to assess the potential effectiveness and feasibility of CA-CBT, specifically tailored for the earthquake survivors, and their mental health issues following the disaster. The main research questions of the study are whether the group CA-CBT is effective in decreasing psychological distress and depressive symptoms and increasing well-being among earthquake survivors one month after post-assessment.
The study is planned to be conducted with the collaboration with non-governmental organizations giving services to earthquake survivors. After the baseline assessment, eligible 60 participants will be randomized to two arms according to the 1:1 principle with automatized randomization software. 30 randomly allocated participants will receive CA-CBT and 30 randomly allocated participants will receive Enhanced Care as Usual (E-CAU) as the control group. One week after the completion of the sessions, all participants including control group participants will have post-assessments consisting of the same questionnaires as baseline assessment. One month after the post-assessment, all participants including control group participants will have follow-up assessments consisting of the same questionnaires as baseline and post-assessments.
If CA-CBT proves effective for individuals affected by earthquakes, it can be disseminated among mental health care professionals. Consequently, more earthquake survivors can access this high-quality evidence-based intervention adapted to their culture.
- Being tested
- Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)
- Keywords
- earthquake survivor, culturally adapted treatment, mental health, cognitive behavioral therapy
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)Behavioural
In this study, an 8- session (90 to 120 minutes) group version of the transdiagnostic intervention CA-CBT tailored for earthquake survivors will be applied.
Contents of the sessions are:
- Education on psychological trauma and its treatment, and basics of emotion regulation techniques
- Education on anxiety and depressive disorders and their treatment
- Muscle relaxation and stretching exercises
- Education about depressive and grief-related disorders and disturbing memories protocol
- Interoceptive exposure: head rotation and hyperventilation
- Anxiety, worry, and stress
- Anger and anger protocol; breathing exercises
- Somatic complaints, sleep disturbance, and closing
There will be one facilitator and one co-facilitator. Groups will consist of 12-13 participants.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) | Experimental | Participants in the experimental group will receive an 8-session group CA-CBT. Receives: Behavioral: Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) |
| Enhanced Care as Usual (E-CAU) | No intervention | Participants in the control group will receive pamphlets containing information on mental health issues following earthquakes, coping strategies, and free psychological support centers. After completing all assessments, CA-CBT will be offered to these participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kessler Psychological Distress Scale (K-10) over time
K-10 is a 10-item scale that measures psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate higher levels of psychological distress.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Secondary outcomes (11)
Change in Patient Health Questionnaire-9 (PHQ-9) over time
PHQ-9 is a 9-item questionnaire that measures 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 higher depressive symptoms.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Generalized Anxiety Disorder-7 (GAD-7) over time
GAD-7 is a 7-item scale of general anxiety disorder that assesses 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.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) over time
WHODAS 2.0 is a 12-item scale that measures ability to engage in daily activities. Each item is scored from 1 (none) to 5 (extreme) and ranges between 12 and 60. Higher scores indicate higher levels of daily dysfunctioning.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
PCL-5 is a 20-item questionnaire that assesses PTSD symptoms. 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 assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Prolonged Grief Disorder-13 (PG-13) over time
The PG-13 instrument contains 13 items: two items (items 3 and 13) on duration and impairment that are to be answered "yes" or "no", and 11 items assessing cognitive, behavioral and emotional symptoms, rated on a 5-point scale. Items 1, 2, 4 and 5 are rated on a frequency scale ranging from: "not at all" to "several times a day" (scoring 1-5), and items 6-12 are rated on an intensity scale ranging from "not at all" to "overwhelmingly" (scoring 1-5). These total scores, ranging from 11 to 55. Higher total scores on the PG-13 indicate more severe symptoms of prolonged grief.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization Quality of Life (WHOQOL-BREF) over time
WHOQOL-BREF is a 26-item scale that measures quality of life. Each item is scored from 1 (not at all) to 5 (completely) providing a range between 26 and 130. Higher scores indicate higher levels of quality of life.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Multidimensional Scale of Perceived Social Support (MSPSS) over time
MSPSS is a 12-item scale that measures perceived social support. Each item is scored from 1 (very strongly disagree) to 7 (very strongly disagree) providing a range between 12 and 84. Higher scores indicate higher levels of perceived social support.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization-Five Well-Being Index (WHO-5) (1998) over time
WHO-5 (1998) is a 5-item scale that measures well-being. Each item is scored from 0 (at no time) to 5 (all of the time) providing a range between 0 and 25. Higher scores indicate higher levels of well-being.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Dispositional Hope Scale (DHS) over time
DHS is a 12-item scale that measures dispositional hope. Each item is scored from 1 (definitely false) to 8 (definitely true) providing a range between 12 and 96. Higher scores indicate higher levels of dispositional hope.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in The Emotion Regulation Questionnaire (ERQ) over time
ERQ is a 10-item questionnaire that measures emotion regulation. Each item is scored from 1 (strongly disagree) to 7 (strongly agree) providing a range between 10 and 70. Higher scores indicate higher levels of emotion regulation.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Acceptance and Action Questionnaire - version 2 (AAQ-2) over time
AAQ-2 is a 7-item questionnaire that measures of psychological inflexibility, experiential avoidance, and potential psychological distress. Each item is scored from 1 (never true) to 7 (always true) providing a range between 7 and 49. Higher scores indicate higher levels of psychological inflexibility, experiential avoidance, and more potential psychological distress.
Measured: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jul 2024
- Primary completion5 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Model description
- A pilot randomized control trial involving 60 participants will be conducted. 30 randomly allocated participants will receive CA-CBT and 30 randomly allocated participants will receive Enhanced Care as Usual (E-CAU) as the control group. One week after the completion of the sessions, all participants including control group participants will have post-assessments consisting of the same questionnaires as baseline assessment with assessors. One month after the post-assessment, with the assessors, all participants including control group participants will have follow-up assessments consisting of the same questionnaires as baseline and post-assessments. After completing all assessments, CA-CBT will be offered to control group participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Şule N. Orhan, Study chair, World Human Relief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189937
- Sponsor's protocol ID
- 2023.060.IRB3.027
- Acronym
- CARED-ACT
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29345479Anadolu Agency. (2023c). Death toll from February earthquakes in Türkiye rises to 50,096. https://www.aa.com.tr/en/turkiye/death-toll-from-february-earthquakes-in-turkiye-rises-to-50-096/2850760
Anik E, West RM, Cardno AG, Mir G. Culturally adapted psychotherapies for depressed adults: A systematic review and meta-analysis. J Affect Disord. 2021 Jan 1;278:296-310. doi: 10.1016/j.jad.2020.09.051. Epub 2020 Sep 15.
PubMed 32979561Bianchini V, Roncone R, Giusti L, Casacchia M, Cifone MG, Pollice R. PTSD Growth and Substance Abuse Among a College Student Community: Coping Strategies after 2009 L'aquila Earthquake. Clin Pract Epidemiol Ment Health. 2015 Mar 31;11:140-3. doi: 10.2174/1745017901511010140. eCollection 2015.
PubMed 25893001Bianchini V, Roncone R, Tomassini A, Necozione S, Cifone MG, Casacchia M, Pollice R. Cognitive behavioral therapy for young people after l'aquila earthquake. Clin Pract Epidemiol Ment Health. 2013 Nov 28;9:238-42. doi: 10.2174/1745017901309010238. eCollection 2013.
PubMed 24358053Cenat JM, McIntee SE, Blais-Rochette C. Symptoms of posttraumatic stress disorder, depression, anxiety and other mental health problems following the 2010 earthquake in Haiti: A systematic review and meta-analysis. J Affect Disord. 2020 Aug 1;273:55-85. doi: 10.1016/j.jad.2020.04.046. Epub 2020 May 7.
PubMed 32421623Chan CL, Wang CW, Ho AH, Qu ZY, Wang XY, Ran MS, Mao WJ, Lu BQ, Zhang BQ, Zhang XL. Symptoms of posttraumatic stress disorder and depression among bereaved and non-bereaved survivors following the 2008 Sichuan earthquake. J Anxiety Disord. 2012 Aug;26(6):673-9. doi: 10.1016/j.janxdis.2012.05.002. Epub 2012 May 29.
PubMed 22721751Ergun D, Senyuz S. Prolonged grief disorder among bereaved survivors after the 2011 Van Earthquake in Turkey. Death Stud. 2022;46(6):1364-1371. doi: 10.1080/07481187.2021.1884624. Epub 2021 Feb 12.
PubMed 33576723Farooqui M, Quadri SA, Suriya SS, Khan MA, Ovais M, Sohail Z, Shoaib S, Tohid H, Hassan M. Posttraumatic stress disorder: a serious post-earthquake complication. Trends Psychiatry Psychother. 2017 Apr-Jun;39(2):135-143. doi: 10.1590/2237-6089-2016-0029.
PubMed 28700042Geng F, Fan F, Mo L, Simandl I, Liu X. Sleep problems among adolescent survivors following the 2008 Wenchuan earthquake in China: a cohort study. J Clin Psychiatry. 2013 Jan;74(1):67-74. doi: 10.4088/JCP.12m07872.
PubMed 23419228Harada N, Shigemura J, Tanichi M, Kawaida K, Takahashi S, Yasukata F. Mental health and psychological impacts from the 2011 Great East Japan Earthquake Disaster: a systematic literature review. Disaster Mil Med. 2015 Sep 2;1:17. doi: 10.1186/s40696-015-0008-x. eCollection 2015.
PubMed 28265432Jiang S, Yan Z, Jing P, Li C, Zheng T, He J. Relationships between Sleep Problems and Psychiatric Comorbidities among China's Wenchuan Earthquake Survivors Remaining in Temporary Housing Camps. Front Psychol. 2016 Oct 18;7:1552. doi: 10.3389/fpsyg.2016.01552. eCollection 2016.
PubMed 27803679Lopes AP, Macedo TF, Coutinho ES, Figueira I, Ventura PR. Systematic review of the efficacy of cognitive-behavior therapy related treatments for victims of natural disasters: a worldwide problem. PLoS One. 2014 Oct 8;9(10):e109013. doi: 10.1371/journal.pone.0109013. eCollection 2014.
PubMed 25296020Orhan, Ş.N. (2020). Travma yaşayan kadınlara kültüre adapte edilmiş bilişsel davranışçı grup terapi uygulanması ve etkilerinin incelenmesi (Eng. The application of culturally adapted cognitive behavioral therapy and investigation of its impact in women with traumatic experiences). Unpublished master's thesis, Graduate School of Social Sciences, Marmara University, İstanbul.
Shooshtary MH, Panaghi L, Moghadam JA. Outcome of cognitive behavioral therapy in adolescents after natural disaster. J Adolesc Health. 2008 May;42(5):466-72. doi: 10.1016/j.jadohealth.2007.09.011. Epub 2008 Mar 4.
PubMed 18407041
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavioral Therapy to Reduce Psychological Distress of Individuals Affected by the Earthquake: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06189937
- Acronym / sponsor ID
- CARED-ACT / 2023.060.IRB3.027
- Keywords
- earthquake survivor, culturally adapted treatment, mental health, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 5 Jan 2024 (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.
Earthquakes in Türkiye cause survivors to develop serious and prolonged mental health issues and adapted versions of cognitive behavioral therapy has proven to be successful in addressing these concerns.The main goal of this pilot randomized control trial (RCT) is to test potential effectiveness of Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) in reducing psychological distress and depressive symptoms and increasing well-being of earthquake survivors.
Detailed description
Türkiye was struck by two large earthquakes with moment magnitudes 7.7. and 7.6, on the 6th of February 2023. The disaster resulted in more than 50 thousand people losing their lives, more than 107 thousand people getting injured and more than 84 thousand buildings being demolished, severely damaged or slated for demolition. After the earthquakes, various mental health issues can emerge among the survivors such as depression, anxiety disorders, posttraumatic stress disorder, sleep problems, prolonged grief disorder, decrease in quality of life, increase in suicidality and substance use, and their effects can be prolonged if not treated.
An effective treatment method for the mental health issues that the earthquake survivors may experience is cognitive behavioral therapy (CBT) which is effective both in individual and group formats. Moreover, culturally adapted versions of CBT demonstrated higher effectiveness. One such adaptation, developed as a transdiagnostic intervention by Devon Hinton, is known as Culturally Adapted CBT (CA-CBT), which has shown effectiveness across various cultures and countries. It has been successfully applied to depressed and traumatized women in Türkiye, reducing depressive symptoms and PTSD. CA-CBT incorporates emotion regulation techniques, mindfulness and stretching exercises as well as cognitive-behavioral approach principles. Some advantages of the CA-CBT are: (1) as a transdiagnostic intervention, it can be applied to treat various psychopathologies (2) as a group intervention, it can be applied to multiple individuals simultaneously, (3) as an 8-session intervention, it can improve mental health in the short term.
CA-CBT has not been tested with a population specifically consisting of individuals affected by earthquakes before. This pilot randomized control trial (RCT) aims to assess the potential effectiveness and feasibility of CA-CBT, specifically tailored for the earthquake survivors, and their mental health issues following the disaster. The main research questions of the study are whether the group CA-CBT is effective in decreasing psychological distress and depressive symptoms and increasing well-being among earthquake survivors one month after post-assessment.
The study is planned to be conducted with the collaboration with non-governmental organizations giving services to earthquake survivors. After the baseline assessment, eligible 60 participants will be randomized to two arms according to the 1:1 principle with automatized randomization software. 30 randomly allocated participants will receive CA-CBT and 30 randomly allocated participants will receive Enhanced Care as Usual (E-CAU) as the control group. One week after the completion of the sessions, all participants including control group participants will have post-assessments consisting of the same questionnaires as baseline assessment. One month after the post-assessment, all participants including control group participants will have follow-up assessments consisting of the same questionnaires as baseline and post-assessments.
If CA-CBT proves effective for individuals affected by earthquakes, it can be disseminated among mental health care professionals. Consequently, more earthquake survivors can access this high-quality evidence-based intervention adapted to their culture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot randomized control trial involving 60 participants will be conducted. 30 randomly allocated participants will receive CA-CBT and 30 randomly allocated participants will receive Enhanced Care as Usual (E-CAU) as the control group. One week after the completion of the sessions, all participants including control group participants will have post-assessments consisting of the same questionnaires as baseline assessment with assessors. One month after the post-assessment, with the assessors, all participants including control group participants will have follow-up assessments consisting of the same questionnaires as baseline and post-assessments. After completing all assessments, CA-CBT will be offered to control group participants.
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) | Experimental | Behavioral: Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)Participants in the experimental group will receive an 8-session group CA-CBT. |
| Enhanced Care as Usual (E-CAU) | No intervention | –Participants in the control group will receive pamphlets containing information on mental health issues following earthquakes, coping strategies, and free psychological support centers. After completing all assessments, CA-CBT will be offered to these participants. |
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 old or older.
- Having experienced the earthquake.
- Having a considerable amount of psychological distress: scoring 16 or higher on the Kessler Psychological Distress Scale (K10).
Key exclusion criteria (2 listed)
- Having a severe mental disorder (conducted by a trained assessor).
- Presenting suicidality (assessed by the Problem Management Plus Suicidality Tool).
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 Therapy (CA-CBT)In this study, an 8- session (90 to 120 minutes) group version of the transdiagnostic intervention CA-CBT tailored for earthquake survivors will be applied. Contents of the sessions are: 1. Education on psychological trauma and its treatment, and basics of emotion regulation techniques 2. Education on anxiety and depressive disorders and their treatment 3. Muscle relaxation and stretching exercises 4. Education about depressive and grief-related disorders and disturbing memories protocol 5. Interoceptive exposure: head rotation and hyperventilation 6. Anxiety, worry, and stress 7. Anger and anger protocol; breathing exercises 8. Somatic complaints, sleep disturbance, and closing There will be one facilitator and one co-facilitator. Groups will consist of 12-13 participants. | Behavioural | Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) |
Primary outcome
Change in Kessler Psychological Distress Scale (K-10) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
K-10 is a 10-item scale that measures psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate higher levels of psychological distress.
11 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Generalized Anxiety Disorder-7 (GAD-7) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Prolonged Grief Disorder-13 (PG-13) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization Quality of Life (WHOQOL-BREF) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Multidimensional Scale of Perceived Social Support (MSPSS) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in World Health Organization-Five Well-Being Index (WHO-5) (1998) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Dispositional Hope Scale (DHS) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in The Emotion Regulation Questionnaire (ERQ) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Change in Acceptance and Action Questionnaire - version 2 (AAQ-2) over time
Time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-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 3 Sep 2025.
- 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.
- BackgroundAnadolu Agency. (2023c). Death toll from February earthquakes in Türkiye rises to 50,096. https://www.aa.com.tr/en/turkiye/death-toll-from-february-earthquakes-in-turkiye-rises-to-50-096/2850760
- Background: PubMed 32979561Anik E, West RM, Cardno AG, Mir G. Culturally adapted psychotherapies for depressed adults: A systematic review and meta-analysis. J Affect Disord. 2021 Jan 1;278:296-310. doi: 10.1016/j.jad.2020.09.051. Epub 2020 Sep 15.
- Background: PubMed 25893001Bianchini V, Roncone R, Giusti L, Casacchia M, Cifone MG, Pollice R. PTSD Growth and Substance Abuse Among a College Student Community: Coping Strategies after 2009 L'aquila Earthquake. Clin Pract Epidemiol Ment Health. 2015 Mar 31;11:140-3. doi: 10.2174/1745017901511010140. eCollection 2015.
- Background: PubMed 24358053Bianchini V, Roncone R, Tomassini A, Necozione S, Cifone MG, Casacchia M, Pollice R. Cognitive behavioral therapy for young people after l'aquila earthquake. Clin Pract Epidemiol Ment Health. 2013 Nov 28;9:238-42. doi: 10.2174/1745017901309010238. eCollection 2013.
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- 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.
Şule N. Orhan study chair
World Human Relief
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 Therapy (CA-CBT) in people with Psychological Distress and Depressive Symptoms, 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 3 Sep 2025. 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?
Change in Kessler Psychological Distress Scale (K-10) over time (time frame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-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 NCT06189937, which also lists 18 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 3 Sep 2025.