Group CA-CBT Intervention to Reduce Psychological Distress of Earthquake Survivors (CARED-ACT)

August 26, 2025 updated by: Koç University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)
Participants in the experimental group will receive an 8-session group CA-CBT.
Behavioral: 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.
No Intervention: Enhanced Care as Usual (E-CAU)
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Change from baseline assessment (one week before the first session of CA-CBT) to follow-up assessment (1 month after post-assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Study Chair: Şule N. Orhan, World Human Relief

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.060.IRB3.027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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