Group CA-CBT Intervention to Reduce Psychological Distress of Earthquake Survivors

NCT06189937 | Completed

• 1 other identifier: 2023.060.IRB3.027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Depressive Symptoms; Well-Being, Psychological

Keywords

earthquake survivor; culturally adapted treatment; mental health; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)

Study Arms (2)

Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)

EXPERIMENTAL

Participants in the experimental group will receive an 8-session group CA-CBT.

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.

Interventions

Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) BEHAVIORAL

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.

Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)

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 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).

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (18)

• 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

• 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

  BACKGROUND

• 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.

  PMID: 32979561 BACKGROUND

• 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.

  PMID: 25893001 BACKGROUND

• 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.

  PMID: 24358053 BACKGROUND

• 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.

  PMID: 32421623 BACKGROUND

• 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.

  PMID: 22721751 BACKGROUND

• 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.

  PMID: 33576723 BACKGROUND

• 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.

  PMID: 28700042 BACKGROUND

• 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.

  PMID: 23419228 BACKGROUND

• 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.

  PMID: 28265432 BACKGROUND

• 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.

  PMID: 27803679 BACKGROUND

• 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.

  PMID: 25296020 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18407041 BACKGROUND

• 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.

  PMID: 22937014 BACKGROUND

• 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.

  PMID: 16279873 BACKGROUND

• 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.

  PMID: 31406818 BACKGROUND

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Şule N. Orhan

  World Human Relief

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to their study arm due to the nature of the intervention, but outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 5, 2024
• Study Start: July 1, 2024
• Primary Completion: December 5, 2024
• Study Completion: January 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)