Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT06026306
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2023-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Scalable Psychological Intervention for Earthquake Survivors in Türkiye
Sponsor:
Koç University
Organization:
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of a Scalable Psychological Intervention for Enhancing Mental Health Outcomes Among Earthquake Survivors in Türkiye
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This will be the first pilot randomized controlled trial (RCT) study that investigate the potential effectiveness of individual PM+ among earthquake survivors residing in container cities in Türkiye. The primary objective of this pilot study will be to test feasibility, acceptability, and potential effectiveness of individual PM+ for Turkish earthquake survivors, using RCT design which is considered the gold standard in research for evaluating effectiveness of interventions. Secondly, this study aims to test trial procedures in preparation for a future larger randomized controlled trial.
Detailed Description:
On the 6th February, 2023, Türkiye experienced two consecutive earthquakes with magnitudes of 7.7 and 7.6. As a consequence of such a disaster, the increasing prevalence of mental health issues has resulted in increased need and demand for mental health and psychosocial support (MHPSS) services in the country. In order to reach a higher number of people on time, implementation of brief, scalable interventions addressing common mental health problems has garnered significant importance. One such intervention is Problem Management Plus that is developed by World Health Organization for communities that experienced adversities. PM+ is a 5-session psychological intervention that aims to improve common mental health problems by teaching participants evidence-based behavioral strategies (i.e., stress management, problem solving, behavioral activation and strengthening social support). Both the individual and group versions of PM+ were tested for feasibility, acceptability, and effectiveness in various countries among different populations, including the earthquake-affected communities in Nepal.
This study will be the first to test the potential effectiveness of individual PM+ among earthquake survivors in Türkiye. The study will be designed as a pilot randomized controlled trial and the potential effectiveness of individual PM+ will be tested compared to Enhanced-Care as Usual (E-CAU) control group. The study is planned to be conducted at container cities in different earthquake regions (e.g.,Hatay, Adıyaman or Malatya). After the baseline assessment, eligible 60 participants will be randomized to two arms: in either the PM+ (n=30) or only control group (E-CAU; n=30). If they will be randomized into the PM+ condition, the facilitator will plan five consecutive sessions with the participants. The first session will take place no longer than one week after the pre-intervention assessment. The post-intervention assessment through the same measures used in the pretest will take place within 1 week after completion of the fifth session. Follow-up assessment will be conducted one month after the last-session. All study participants including drop-outs will be invited to all outcome assessments. After completion of the follow-up assessment, those in the E-CAU condition will be offered with PM+. The primary outcome measure will be depression and anxiety, posttraumatic stress, psychological distress, psychosocial functioning and self-identified problems will be included as secondary outcome measures.
In order to assess feasibility and acceptability of these interventions, and the possibility of scaling up as well, we will assess the recruitment and consent rates, the percentages of attendance of sessions, the protocol adherence, drop-out rates and qualitative assessments from the process evaluation.
This study will be the first to test the potential effectiveness of individual PM+ among earthquake survivors in Türkiye. The study will be designed as a pilot randomized controlled trial and the potential effectiveness of individual PM+ will be tested compared to Enhanced-Care as Usual (E-CAU) control group. The study is planned to be conducted at container cities in different earthquake regions (e.g.,Hatay, Adıyaman or Malatya). After the baseline assessment, eligible 60 participants will be randomized to two arms: in either the PM+ (n=30) or only control group (E-CAU; n=30). If they will be randomized into the PM+ condition, the facilitator will plan five consecutive sessions with the participants. The first session will take place no longer than one week after the pre-intervention assessment. The post-intervention assessment through the same measures used in the pretest will take place within 1 week after completion of the fifth session. Follow-up assessment will be conducted one month after the last-session. All study participants including drop-outs will be invited to all outcome assessments. After completion of the follow-up assessment, those in the E-CAU condition will be offered with PM+. The primary outcome measure will be depression and anxiety, posttraumatic stress, psychological distress, psychosocial functioning and self-identified problems will be included as secondary outcome measures.
In order to assess feasibility and acceptability of these interventions, and the possibility of scaling up as well, we will assess the recruitment and consent rates, the percentages of attendance of sessions, the protocol adherence, drop-out rates and qualitative assessments from the process evaluation.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: