Mental Health IssueNCT05993507
Mental Health Outcomes of Earthquake Survivors in Türkiye
A study testing Problem Management Plus (PM+) in people with Mental Health Issue, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this open trial pilot study will be to test feasibility, acceptability, and potential impact of Problem Management Plus (PM+), brief, scalable psychological intervention developed by WHO, for earthquake survivors in Türkiye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Problem Management Plus (PM+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years or above
- being experienced the earthquake
- reported elevated level of psychological distress indicated by a score of >15 on Kessler Psychological Distress Scale
- reported impaired daily functioning indicated by a score of >16 on World Health Organization Disability Assessment Scale
Who cannot join
- imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview)
- severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability (assessed by the PM+ manual observation checklist)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Scalable Psychological Intervention to Improve Mental Health Outcomes of Earthquake Survivors in Türkiye: An Open Trial Pilot Study
The primary aim of this open trial pilot study will be to test feasibility, acceptability, and potential impact of Problem Management Plus (PM+), brief, scalable psychological intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims to assess trial procedures in preparation for a future studies evaluating the effectiveness of PM+ intervention with earthquake survivors.
Read the detailed description
Considering the fact that around 16% of Turkey's population is affected by the February 6 earthquakes, reaching a higher number of people on time can be achieved through the implementation of brief, scalable interventions addressing common mental health problems. This will be the first study that investigate the individual PM+ among earthquake survivors in Türkiye. Testing these interventions will provide evidence for further use in future disasters.
The study will assess changes in depression, anxiety, posttraumatic stress symptoms, psychological distress, and psychosocial functioning scores before and after the intervention. The hypothesis to be examined posits that participants will have significantly lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial functioning scores at the post assessment compared to pre-assessment.
This study will be designed as a single group pre-and post-test research. The sample will be adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their work with people who experienced the earthquake. The outcome measures will be assessed two times: once before and once after PM+ will be conducted. After the baseline assessment, all participants will receive the consecutive 5-session on individual PM+. The PM+ intervention consists of five weekly sessions incorporating evidence-based behavioral strategies.
- Conditions
- Mental Health Issue
- Being tested
- Problem Management Plus (PM+)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Management Plus (PM+)Behavioural
Problem Management Plus (PM+) is a brief, scalable intervention that is developed by World Health Organization for communities exposed to adversity. PM+ consists of five weekly in-person sessions of 90 minutes. The intervention integrates four evidence-based behavioural strategies: arousal reduction using a slow breathing exercise (session 1), problem-solving (session 2), behavioural activation by re-engaging with pleasant and task-oriented activities (session 3) and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention is discussed in session 5. Facilitators will receive weekly supervisions by PM+ supervisors.
| Study group | Role | What they receive |
|---|---|---|
| Problem Management Plus (PM+) | Experimental | As an open trial single group pre-post design, all participants in the study will receive PM+. Receives: Behavioral: Problem Management Plus (PM+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Patient Health Questionnaire-9 (PHQ-9) over time
PHQ-9 is a 9 item questionnaire that measures the severity of depression symptoms. Items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate more severe depressive symptoms.
Measured: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Secondary outcomes (4)
Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
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.
Measured: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
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.
Measured: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the Kessler Psychological Distress Scale (K-10) over time
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.
Measured: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time
WHODAS is a 12-item scale that assesses ability to engage in daily activities. Each item is scored from 0 (none) to 4 (extreme) and ranges between 0 and 48. Higher scores indicate more daily dysfunctioning.
Measured: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start17 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşenur Coşkun Toker, MA, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993507
- Sponsor's protocol ID
- 2023.214.IRB3.097
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32452336Dawson 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.
PubMed 26407793
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable Psychological Intervention to Improve Mental Health Outcomes of Earthquake Survivors in Türkiye: An Open Trial Pilot Study
- ClinicalTrials.gov ID
- NCT05993507
- Acronym / sponsor ID
- 2023.214.IRB3.097
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this open trial pilot study will be to test feasibility, acceptability, and potential impact of Problem Management Plus (PM+), brief, scalable psychological intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims to assess trial procedures in preparation for a future studies evaluating the effectiveness of PM+ intervention with earthquake survivors.
Detailed description
Considering the fact that around 16% of Turkey's population is affected by the February 6 earthquakes, reaching a higher number of people on time can be achieved through the implementation of brief, scalable interventions addressing common mental health problems. This will be the first study that investigate the individual PM+ among earthquake survivors in Türkiye. Testing these interventions will provide evidence for further use in future disasters.
The study will assess changes in depression, anxiety, posttraumatic stress symptoms, psychological distress, and psychosocial functioning scores before and after the intervention. The hypothesis to be examined posits that participants will have significantly lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial functioning scores at the post assessment compared to pre-assessment.
This study will be designed as a single group pre-and post-test research. The sample will be adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their work with people who experienced the earthquake. The outcome measures will be assessed two times: once before and once after PM+ will be conducted. After the baseline assessment, all participants will receive the consecutive 5-session on individual PM+. The PM+ intervention consists of five weekly sessions incorporating evidence-based behavioral strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Management Plus (PM+) | Experimental | Behavioral: Problem Management Plus (PM+)As an open trial single group pre-post design, all participants in the study will receive PM+. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 18 years or above
- being experienced the earthquake
- reported elevated level of psychological distress indicated by a score of >15 on Kessler Psychological Distress Scale
- reported impaired daily functioning indicated by a score of >16 on World Health Organization Disability Assessment Scale
Key exclusion criteria (2 listed)
- imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview)
- severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability (assessed by the PM+ manual observation checklist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Management Plus (PM+)Problem Management Plus (PM+) is a brief, scalable intervention that is developed by World Health Organization for communities exposed to adversity. PM+ consists of five weekly in-person sessions of 90 minutes. The intervention integrates four evidence-based behavioural strategies: arousal reduction using a slow breathing exercise (session 1), problem-solving (session 2), behavioural activation by re-engaging with pleasant and task-oriented activities (session 3) and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention is discussed in session 5. Facilitators will receive weekly supervisions by PM+ supervisors. | Behavioural | Problem Management Plus (PM+) |
Primary outcome
Change of the Patient Health Questionnaire-9 (PHQ-9) over time
Time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
PHQ-9 is a 9 item questionnaire that measures the severity of depression symptoms. Items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate more severe depressive symptoms.
4 secondary outcomes
Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
Time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
Time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the Kessler Psychological Distress Scale (K-10) over time
Time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time
Time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 32452336Sangraula 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.
- Background: PubMed 26407793Dawson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşenur Coşkun Toker, MA study chair
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Management Plus (PM+) in people with Mental Health Issue, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Patient Health Questionnaire-9 (PHQ-9) over time (time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.