The Feasibility of Cognitive Process Therapy in Earthquake-affected Population With Mental Health Problems in Türkiye
- Conditions
- Post Traumatic Stress DisorderWell-Being, PsychologicalAnxiety Disorders and SymptomsDepressive Symptoms
- Interventions
- Other: Cognitive Processing Therapy
- Registration Number
- NCT06136481
- Lead Sponsor
- Koç University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Cognitive Processing Therapy CPT intervention: participants will attend the 12 consecutive sessions administered by a psychologist in twice a week.
- Primary Outcome Measures
Name Time Method Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) 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 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.
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 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 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 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.