Clinical trial NCT06026306: A Scalable Psychological Intervention for Earthquake Survivors in Türkiye
Official title: A Pilot Randomized Controlled Trial of a Scalable Psychological Intervention for Enhancing Mental Health Outcomes Among Earthquake Survivors in Türkiye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Impaired Social Functioning
Depressive Symptoms
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 76
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: 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.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or above
* Being experienced the Kahramanmaraş earthquake
* Elevated level of psychological distress indicated by having a score of 15 or above on Kessler Psychological Distress Scale (K10)
* Impaired daily functioning indicated by having a score of 16 or above on WHO Disability Assessment Schedule (WHODAS)

Exclusion Criteria:

* imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview),
* indications of severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability; assessed by the PM+ manual observation checklist),
* ongoing treatment in specialized mental health care.

Primary outcomes:
measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
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 PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
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 PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
measure: Change of the Kessler Psychological Distress Scale (K-10) over time
timeFrame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
measure: Change of the World Health Organization Disability Assessment Schedule (WHODAS 2.0) over time
timeFrame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
measure: Change of the the psychological outcomes profiles (PSYCHLOPS) over time
timeFrame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
Study officials:
affiliation: Koç University
name: Ayşenur Coşkun Toker, PhD student
role: STUDY_CHAIR
References:
citation: Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
citation: Sangraula M, Turner EL, Luitel NP, van 't Hof E, Shrestha P, Ghimire R, Bryant R, Marahatta K, van Ommeren M, Kohrt BA, Jordans MJD. Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Epidemiol Psychiatr Sci. 2020 May 26;29:e130. doi: 10.1017/S2045796020000414.