Clinical trial NCT06136481: The Feasibility of Cognitive Process Therapy in Earthquake-affected Population With Mental Health Problems in Türkiye
Official title: A Pilot Randomized Control Trial of Cognitive Processing Therapy for Mental Health Problems in Earthquake Exposed Adults.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depressive Symptoms
Well-Being, Psychological
Anxiety Disorders and Symptoms
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
timeFrame: 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:
measure: Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
timeFrame: 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
measure: Change of the World Health Organization (WHO) Well-Being Scale over time
timeFrame: 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
measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: 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
measure: Change of the Kessler Psychological Distress Scale (K-10) over time
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Koç University
name: Büşra Acar, PhD Student
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.