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

K

Koç University

Status

Enrolling

Conditions

Depressive Symptoms
Well-Being, Psychological
Psychological Distress

Treatments

Behavioral: Culturally Adapted Cognitive Behavioral Therapy (CA-CBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06189937
2023.060.IRB3.027

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

Şule N. Orhan; Ceren Acartürk, Assoc. Prof.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems