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

NCT06136481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Koç University

    lead OTHER

Principal Investigators

  • Büşra Acar, PhD Student · Koç University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-25
Primary Completion
2025-01-21
Completion
2025-02-06

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06136481 on ClinicalTrials.gov