The Feasibility of Cognitive Process Therapy in Earthquake-affected Population With Mental Health Problems in Türkiye

August 27, 2025 updated by: Koç University

A Pilot Randomized Control Trial of Cognitive Processing Therapy for Mental Health Problems in Earthquake Exposed Adults.

The aim of the study is to test the pilot effectiveness of Cognitive Processing Therapy (CPT) in decreasing psychological distress and post-traumatic stress disorder (PTSD) symptoms and increasing well-being in earthquake survivors in Türkiye, using randomized controlled trial study design, which is considered the gold standard in research for evaluating the effectiveness of interventions. This pilot study will help to identify any further adaptations required prior to further effectiveness testing in a large cluster randomized controlled trial.

Study hypothesis:

Hypothesis 1: The participants who receive the CPT will have a significantly higher decrease in PTSD symptoms compared to the participants in the care-as-usual control group at the post-assessment.

Hypothesis 2: The participants who receive the CPT will have a significantly higher decrease in depressive symptom severity compared to the participants in the care-as-usual control group at the post-assessment.

Hypothesis 4: The participants who receive the CPT will have a significantly higher decrease in anxiety severity compared to the participants in the care-as-usual control group at the post-assessment.

Hypothesis 5: The participants who receive the CPT will have a significantly higher increase in well-being compared to the participants in the care-as-usual control group at post-assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two large earthquakes struck Türkiye on the 6th of February 2023, affecting more than 14 million people, around 16% of the population, including more than 45.000 lost and 3.3 million displaced. Considering the current scale of the recent earthquakes in Türkiye, implementing and disseminating evidence-based psychosocial interventions, especially trauma-focused treatment approaches such as Cognitive Processing Therapy (CPT), is crucial in order to respond to the increasing mental health needs of the earthquake survivors. Cognitive Processing Therapy (CPT) is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging. The manualized treatment focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Randomized clinical trials have revealed that CPT is an effective treatment for PTSD and other comorbid conditions in a variety of civilian trauma populations.

The study will be designed as a pilot randomized controlled trial, and the potential effectiveness of individual CPT will be tested compared to the Enhanced-Care as Usual (E-CAU) control group. CPT will be implemented on Zoom, which is an online platform with HIPAA compliance. After the baseline assessment, 30 eligible participants will be randomized to two arms: in either the CPT (n =15) or only the control group (E-CAU; n=15). The first session will take place no longer than one week after the pre-intervention assessment. The post-intervention assessment through the same measures will be scheduled six weeks after the pre-intervention assessment (i.e., one week after the 12th CPT session). The follow-up assessment will be conducted one month after the post-assessment. All study participants, including dropouts, will be invited to all outcome assessments. The primary outcome is post-traumatic stress disorder, and the following are the secondary clinical outcomes: symptoms of depression, anxiety, and well-being.

Study Type

Interventional

Enrollment (Actual)

36

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

  • Turkey (Türkiye)
    • Istanbul
      • Sarıyer, Istanbul, Turkey (Türkiye), 34450
        • Koc University

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:

  • 18 years or above
  • Individuals who were directly impacted by earthquakes in Turkey, in February 2023, learned that the earthquakes significantly impacted a close family member or close friend, or who were exposed to aversive details of the earthquake as part of their job.
  • Scoring greater than 47 on the Post-Traumatic Stress Disorder Check List for PTSD symptoms

Exclusion Criteria:

  • Acute medical conditions
  • Imminent suicide risk
  • Expressed acute needs/protection risks
  • Indications of severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability)
  • Severe cognitive impairment (e.g., severe intellectual disability or dementia)

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: Intervention group
CPT intervention: participants will attend the 12 consecutive sessions administered by a psychologist in twice a week.
Other: Cognitive Processing Therapy
Cognitive Processing Therapy (CPT). CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. Prior to engaging in therapy, one session will be devoted to gathering information regarding psychosocial history, trauma, and current functioning. The following sessions will follow the standard outpatient CPT protocol. The standard outpatient CPT consists of 12 one-hour sessions conducted over a 6- to 12-week period. An additional 3 weeks will be provided in case of participant and therapist vacation and/or sick days. CPT is delivered in three phases: education, processing, and challenging. The manualized treatment focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.
No Intervention: Control group
The control (enhanced care as usual) group will receive the information about freely available psychological support options. E-CAU ranges from standard community care which may include any existing mental health support services available to earthquake survivors in container cities. The participants will be given flyers which include information about the services provided by the government and by non-governmental organizations. After completion of the post and follow-up assessment of experimental group, those in the E-CAU condition will be offered with CPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
Time Frame: change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
The PCL-5 is a 20-item questionnaire that assesses the symptoms of PTSD. Items are scored from 0 (not at all) to 4 (extremely) providing a range between 0 and 16. Higher scores indicate higher levels of PTSD symptoms.
change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
Time Frame: change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
GAD-7 is a 7-item measure of general anxiety symptoms that measures 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 (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
Change of the World Health Organization (WHO) Well-Being Scale over time
Time Frame: change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
WHO Well-being is a 5-item scale that assesses well-being over the last two weeks . Each item is scored from 0 (at no the time) to 5 (all the time) and ranges between 0 and 100 with lower scores indicating worse well-being.
change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
Change of the Patient Health Questionnaire-9 (PHQ-9) over time
Time Frame: change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
PHQ-9 is a 9-item questionnaire that aims to measure the 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 more severe depressive symptoms.
change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
Change of the Kessler Psychological Distress Scale (K-10) over time
Time Frame: change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention
K-10 is a 10-item scale that assesses the 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 more severe psychological distress.
change from baseline (one week before the first session of CPT) to post assessment (one week after the last session of CPT); which is expected to last an average of 7 weeks to and 1 months after the intervention

Collaborators and Investigators

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

Sponsor

Koç University

Investigators

  • Study Chair: Büşra Acar, PhD Student, Koc University

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

Helpful Links

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)

February 25, 2024

Primary Completion (Actual)

January 21, 2025

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.240.IRB3.110

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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