Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136481
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-11-13
Brief Title:
The Feasibility of Cognitive Process Therapy in Earthquake-affected Population With Mental Health Problems in Türkiye
Sponsor:
Koç University
Organization:
Koç University
Study Overview
Official Title:
A Pilot Randomized Control Trial of Cognitive Processing Therapy for Mental Health Problems in Earthquake Exposed Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 45000 lost and 33 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 n15 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 ie 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
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 n15 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None