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

NCT06136481 | Completed

• 1 other identifier: 2023.240.IRB3.110
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder; Depressive Symptoms; Well-Being, Psychological; Anxiety Disorders and Symptoms

Outcome Measures

Primary Outcomes (1)

• Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time

  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 Outcomes (4)

• Change of the Generalized Anxiety Disorder-7 (GAD-7) over time

  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

  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

  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

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

CPT intervention: participants will attend the 12 consecutive sessions administered by a psychologist in twice a week.

Other: Cognitive Processing Therapy

Control group

NO INTERVENTION

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

Interventions

Cognitive Processing Therapy OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Sarıyer, Istanbul, 34450, Turkey (Türkiye)

Location

Related Publications (4)

• Moring JC, Dondanville KA, Fina BA, Hassija C, Chard K, Monson C, LoSavio ST, Wells SY, Morland LA, Kaysen D, Galovski TE, Resick PA. Cognitive Processing Therapy for Posttraumatic Stress Disorder via Telehealth: Practical Considerations During the COVID-19 Pandemic. J Trauma Stress. 2020 Aug;33(4):371-379. doi: 10.1002/jts.22544. Epub 2020 Jun 11.

  PMID: 32400911 BACKGROUND

• Asmundson GJG, Thorisdottir AS, Roden-Foreman JW, Baird SO, Witcraft SM, Stein AT, Smits JAJ, Powers MB. A meta-analytic review of cognitive processing therapy for adults with posttraumatic stress disorder. Cogn Behav Ther. 2019 Jan;48(1):1-14. doi: 10.1080/16506073.2018.1522371. Epub 2018 Oct 18.

  PMID: 30332919 BACKGROUND

• Brown WJ, Dewey D, Bunnell BE, Boyd SJ, Wilkerson AK, Mitchell MA, Bruce SE. A Critical Review of Negative Affect and the Application of CBT for PTSD. Trauma Violence Abuse. 2018 Apr;19(2):176-194. doi: 10.1177/1524838016650188. Epub 2016 Jun 14.

  PMID: 27301345 BACKGROUND

• Thomas N, McDonald C, de Boer K, Brand RM, Nedeljkovic M, Seabrook L. Review of the current empirical literature on using videoconferencing to deliver individual psychotherapies to adults with mental health problems. Psychol Psychother. 2021 Sep;94(3):854-883. doi: 10.1111/papt.12332. Epub 2021 Feb 23.

  PMID: 33620133 BACKGROUND

Related Links

• General information about CPT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Büşra Acar, PhD Student

  Koç University

  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 because of the nature of the intervention, but outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: February 25, 2024
• Primary Completion: January 21, 2025
• Study Completion: February 6, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)