Clinical trial NCT06189937: Group CA-CBT Intervention to Reduce Psychological Distress of Earthquake Survivors
Official title: Culturally Adapted Cognitive Behavioral Therapy to Reduce Psychological Distress of Individuals Affected by the Earthquake: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Depressive Symptoms
Well-Being, Psychological
Keywords: earthquake survivor
culturally adapted treatment
mental health
cognitive behavioral therapy
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Having a severe mental disorder (conducted by a trained assessor).
* Presenting suicidality (assessed by the Problem Management Plus Suicidality Tool).

Primary outcomes:
measure: Change in Kessler Psychological Distress Scale (K-10) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Prolonged Grief Disorder-13 (PG-13) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in World Health Organization Quality of Life (WHOQOL-BREF) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in World Health Organization-Five Well-Being Index (WHO-5) (1998) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Dispositional Hope Scale (DHS) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in The Emotion Regulation Questionnaire (ERQ) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
measure: Change in Acceptance and Action Questionnaire - version 2 (AAQ-2) over time
timeFrame: Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: World Human Relief
name: Şule N. Orhan
role: STUDY_CHAIR
References:
citation: 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.
citation: Anadolu 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
citation: 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.
citation: Bianchini 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.
citation: Bianchini 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.
citation: Cenat 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.
citation: Chan 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.
citation: Ergun 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.
citation: Farooqui 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.
citation: Geng 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.
citation: Harada 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.
citation: Jiang 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.
citation: Lopes 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.
citation: Orhan, 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.
citation: 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.
citation: Wen J, Shi YK, Li YP, Yuan P, Wang F. Quality of life, physical diseases, and psychological impairment among survivors 3 years after Wenchuan earthquake: a population based survey. PLoS One. 2012;7(8):e43081. doi: 10.1371/journal.pone.0043081. Epub 2012 Aug 21.
citation: Yang CH, Xirasagar S, Chung HC, Huang YT, Lin HC. Suicide trends following the Taiwan earthquake of 1999: empirical evidence and policy implications. Acta Psychiatr Scand. 2005 Dec;112(6):442-8. doi: 10.1111/j.1600-0447.2005.00603.x.
citation: Yi X, Gao J, Wu C, Bai D, Li Y, Tang N, Liu X. Prevalence and risk factors of prolonged grief disorder among bereaved survivors seven years after the Wenchuan earthquake in China: A cross-sectional study. Int J Nurs Sci. 2018 Apr 17;5(2):157-161. doi: 10.1016/j.ijnss.2018.04.001. eCollection 2018 Apr 10.