DistressSTRENGTHS_CHNCT03830008
Scaling-up Psychological Interventions With Syrian Refugees in Switzerland
A study testing Problem Management Plus in people with Distress and PTSD, run by University of Zurich at 1 site in Switzerland.
Trial summary
The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Problem Management Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Dec 2018to 20 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Syrian refugees or asylum seekers who entered Switzerland after the beginning of Syrian Civil War in March 2011
- ≥ 18 years of age
- Arabic-speaking
- Signed Informed Consent after being informed
- Increased psychological distress (K10 > 15)
- Reduced psychological functioning (WHODAS 2.0 > 16)
Who cannot join
- Inability to follow the procedures of the study
- Previous enrolment into the current study
- Previous or currently enrolment of a family member into the current study
- Participants under tutelage
- Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g. dementia)
- Imminent suicide risk
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8006
About this study
The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The feasibility of PM+ has never been examined in Switzerland before, this is the aim of the current pilot study.
Read the detailed description
Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too. Eight percent of asylum requests in 2016 were made by people from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last two years. Due to the ongoing war in this region, it is unlikely that this kind of migration and flight will stop. Notably, 50% of the refugee population are children and adolescents.
Refugees have typically been exposed to multiple stressors related to war and displacement including loss of family members, destruction of homes and livelihoods and human rights violations such as sexual violence or torture. They have often undertaken a risky and stressful flight leaving their homes for an unknown future. Accordingly, studies consistently show that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will develop some type of mental health problem and therefore represent an enormous public mental health challenge.
According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring countries where appropriate health care is mostly not available. But also Western health systems are often unable to appropriately cover the needs of this particularly vulnerable population regarding prevention and treatment of mental health problems. As a response to this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed at treating a certain mental disorder) programs to reduce common mental health symptoms and improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression, anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. PM+ has been successfully implemented in Kenya and Pakistan.
The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the effectiveness and implementation of PM+ with Syrian refugees in different settings in low- and high-resource countries. The study consortium includes international experts in the domains of trauma and public mental health as well as representatives of WHO and UNHCR. The Zürich study site has been consigned to examine PM+ with adult refugees in an individual treatment setting in Switzerland. At the same time, similar studies in other countries will be undertaken. Despite the objective of these studies to implement and evaluate the effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the other studies will be completed in different treatment settings - i.e., in children and adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+ (Germany and Egypt).
To date, the feasibility of PM+ has not been investigated in a highly industrialized country, such as Switzerland.
In the present study, the investigators will evaluate the feasibility of PM+ in Syrian refugees in Switzerland.
This research entails single-blind randomized controlled trial.
The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are already identified, recruited an trained.
After the approval, the first participants will be identified, invited to screening and if they fulfill the criteria they will be invited to participate in the pilot study. The pilot study will end by the end of 2019. After the pilot study the results will be evaluated, analyzed and integrated in the planning of the definitive randomized controlled trial (RCT) (next study, not the part of current registration).
- Conditions
- Distress, PTSD, Anxiety, Depression, Trauma, Functional Disabilities
- Being tested
- Problem Management Plus
- Keywords
- Problem Management Plus, Distress, Mental Health Care, Low-intensity, Refugees
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Management PlusBehavioural
PM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Treatment As Usual (ETAU) | No intervention | The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system). |
| Problem Management Plus | Experimental | PM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (CBT) techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines. Receives: Behavioral: Problem Management Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification procedure to the measurement in psychological distress at baseline assessment
measured by the Hopkins Symptom Checklist (HSCL-25)
Measured: baseline assessment (before PM+)
Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU
measured by the Hopkins Symptom Checklist (HSCL-25)
Measured: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU
measured by the Hopkins Symptom Checklist (HSCL-25)
Measured: 3-months follow-up (after PM+/ETAU)
Secondary outcomes (14)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Measured: baseline assessment (before PM+)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Measured: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Measured: 3-months follow-up (after PM+/ETAU)
Verification procedure to the measurement of functional disability at screening
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Measured: screening (before PM+)
Verification procedure to the measurement of functional disability after PM+ intervention or ETAU
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Measured: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Measured: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Measured: screening (before PM+)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Measured: baseline assessment (before PM+)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Measured: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Measured: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Measured: screening (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Measured: baseline assessment (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Measured: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Measured: 3-months follow-up (after PM+/ETAU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start21 Dec 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The exploratory RCT will inform us about the feasibility, safety, and delivery of the intervention; this will identify issues around its training, supervision and outcome measures. After the baseline assessment, sixty participants (N = 60) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=30) or the ETAU control condition (n=30)). The investigators intend to deliver the intervention to 30 participants, allowing us to test the feasibility and acceptability of the intervention in the proposed setting and inform the sample size for a future definitive trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naser Morina, PhD, Principal investigator, University Hospital Zurich / University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830008
- Sponsor's protocol ID
- BASEC-2017-01175
- Acronym
- STRENGTHS_CH
- Status last verified
- Feb 2021
- First submitted
- 7 Jan 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sijbrandij M, Acarturk C, Bird M, Bryant RA, Burchert S, Carswell K, de Jong J, Dinesen C, Dawson KS, El Chammay R, van Ittersum L, Jordans M, Knaevelsrud C, McDaid D, Miller K, Morina N, Park AL, Roberts B, van Son Y, Sondorp E, Pfaltz MC, Ruttenberg L, Schick M, Schnyder U, van Ommeren M, Ventevogel P, Weissbecker I, Weitz E, Wiedemann N, Whitney C, Cuijpers P. Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol. 2017 Nov 7;8(sup2):1388102. doi: 10.1080/20008198.2017.1388102. eCollection 2017.
PubMed 29163867Dawson 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 26407793Hassan, G., Kirmayer, L. J., Mekki-Berrada, A., Quosh, C., el Chammay, R., Deville-Stoetzel, J., . . . Coutts, A. (2015). Culture, context and the mental health and psychosocial wellbeing of Syrians: a review for mental health and psychosocial support staff working with Syrians affected by armed conflict. Geneva: UNHCR.
Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/
PubMed 24049868Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
PubMed 27265713Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132.
PubMed 19654388Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unutzer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.
PubMed 22110406Tol WA, Barbui C, van Ommeren M. Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA. 2013 Aug 7;310(5):477-8. doi: 10.1001/jama.2013.166723. No abstract available.
PubMed 23925613mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/
PubMed 27786430Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P., Marx, B., & Schnurr, P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J. The Harvard Trauma Questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. J Nerv Ment Dis. 1992 Feb;180(2):111-6.
PubMed 1737972
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling-up Psychological Interventions With Syrian Refugees in Switzerland
- ClinicalTrials.gov ID
- NCT03830008
- Acronym / sponsor ID
- STRENGTHS_CH / BASEC-2017-01175
- Conditions
- Distress, PTSD, Anxiety, Depression, Trauma, Functional Disabilities
- Keywords
- Problem Management Plus, Distress, Mental Health Care, Low-intensity, Refugees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 5 Feb 2019 (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 current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The feasibility of PM+ has never been examined in Switzerland before, this is the aim of the current pilot study.
Detailed description
Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too. Eight percent of asylum requests in 2016 were made by people from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last two years. Due to the ongoing war in this region, it is unlikely that this kind of migration and flight will stop. Notably, 50% of the refugee population are children and adolescents.
Refugees have typically been exposed to multiple stressors related to war and displacement including loss of family members, destruction of homes and livelihoods and human rights violations such as sexual violence or torture. They have often undertaken a risky and stressful flight leaving their homes for an unknown future. Accordingly, studies consistently show that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will develop some type of mental health problem and therefore represent an enormous public mental health challenge.
According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring countries where appropriate health care is mostly not available. But also Western health systems are often unable to appropriately cover the needs of this particularly vulnerable population regarding prevention and treatment of mental health problems. As a response to this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed at treating a certain mental disorder) programs to reduce common mental health symptoms and improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression, anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. PM+ has been successfully implemented in Kenya and Pakistan.
The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the effectiveness and implementation of PM+ with Syrian refugees in different settings in low- and high-resource countries. The study consortium includes international experts in the domains of trauma and public mental health as well as representatives of WHO and UNHCR. The Zürich study site has been consigned to examine PM+ with adult refugees in an individual treatment setting in Switzerland. At the same time, similar studies in other countries will be undertaken. Despite the objective of these studies to implement and evaluate the effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the other studies will be completed in different treatment settings - i.e., in children and adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+ (Germany and Egypt).
To date, the feasibility of PM+ has not been investigated in a highly industrialized country, such as Switzerland.
In the present study, the investigators will evaluate the feasibility of PM+ in Syrian refugees in Switzerland.
This research entails single-blind randomized controlled trial.
The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are already identified, recruited an trained.
After the approval, the first participants will be identified, invited to screening and if they fulfill the criteria they will be invited to participate in the pilot study. The pilot study will end by the end of 2019. After the pilot study the results will be evaluated, analyzed and integrated in the planning of the definitive randomized controlled trial (RCT) (next study, not the part of current registration).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The exploratory RCT will inform us about the feasibility, safety, and delivery of the intervention; this will identify issues around its training, supervision and outcome measures. After the baseline assessment, sixty participants (N = 60) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=30) or the ETAU control condition (n=30)). The investigators intend to deliver the intervention to 30 participants, allowing us to test the feasibility and acceptability of the intervention in the proposed setting and inform the sample size for a future definitive trial.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Treatment As Usual (ETAU) | No intervention | –The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system). |
| Problem Management Plus | Experimental | Behavioral: Problem Management PlusPM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (CBT) techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female Syrian refugees or asylum seekers who entered Switzerland after the beginning of Syrian Civil War in March 2011
- ≥ 18 years of age
- Arabic-speaking
- Signed Informed Consent after being informed
- Increased psychological distress (K10 > 15)
Key exclusion criteria (6 listed)
- Inability to follow the procedures of the study
- Previous enrolment into the current study
- Previous or currently enrolment of a family member into the current study
- Participants under tutelage
- Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g. dementia)
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 PlusPM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines. | Behavioural | Problem Management Plus |
Primary outcome
Verification procedure to the measurement in psychological distress at baseline assessment
Time frame: baseline assessment (before PM+)
measured by the Hopkins Symptom Checklist (HSCL-25)
Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU
Time frame: post-assessment baseline (after PM+/ETAU)
measured by the Hopkins Symptom Checklist (HSCL-25)
Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU
Time frame: 3-months follow-up (after PM+/ETAU)
measured by the Hopkins Symptom Checklist (HSCL-25)
14 secondary outcomes
Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment
Time frame: baseline assessment (before PM+)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU
Time frame: 3-months follow-up (after PM+/ETAU)
Verification procedure to the measurement of functional disability at screening
Time frame: screening (before PM+)
Verification procedure to the measurement of functional disability after PM+ intervention or ETAU
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU
Time frame: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Time frame: screening (before PM+)
Feasibility of PM+ by the number of dropouts
Time frame: baseline assessment (before PM+)
Feasibility of PM+ by the number of dropouts
Time frame: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Time frame: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Time frame: screening (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Time frame: baseline assessment (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Time frame: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Time frame: 3-months follow-up (after PM+/ETAU)
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 8 Feb 2021.
- Background: PubMed 29163867Sijbrandij M, Acarturk C, Bird M, Bryant RA, Burchert S, Carswell K, de Jong J, Dinesen C, Dawson KS, El Chammay R, van Ittersum L, Jordans M, Knaevelsrud C, McDaid D, Miller K, Morina N, Park AL, Roberts B, van Son Y, Sondorp E, Pfaltz MC, Ruttenberg L, Schick M, Schnyder U, van Ommeren M, Ventevogel P, Weissbecker I, Weitz E, Wiedemann N, Whitney C, Cuijpers P. Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol. 2017 Nov 7;8(sup2):1388102. doi: 10.1080/20008198.2017.1388102. eCollection 2017.
- 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.
- BackgroundHassan, G., Kirmayer, L. J., Mekki-Berrada, A., Quosh, C., el Chammay, R., Deville-Stoetzel, J., . . . Coutts, A. (2015). Culture, context and the mental health and psychosocial wellbeing of Syrians: a review for mental health and psychosocial support staff working with Syrians affected by armed conflict. Geneva: UNHCR.
- Background: PubMed 24049868Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/
- Background: PubMed 27265713Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
- Background: PubMed 19654388Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132.
- Background: PubMed 22110406Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unutzer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.
- Background: PubMed 23925613Tol WA, Barbui C, van Ommeren M. Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA. 2013 Aug 7;310(5):477-8. doi: 10.1001/jama.2013.166723. No abstract available.
- Background: PubMed 27786430mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/
- BackgroundWeathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P., Marx, B., & Schnurr, P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
- Background: PubMed 1737972Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J. The Harvard Trauma Questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. J Nerv Ment Dis. 1992 Feb;180(2):111-6.
- Individual participant dataSharing planned: Undecided
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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.
Naser Morina, PhD principal investigator
University Hospital Zurich / University of Zurich
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 in people with Distress and PTSD, run by University of Zurich at 1 site in Switzerland.
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 6 inclusion and 6 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 8 Feb 2021. 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 Switzerland. 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?
Verification procedure to the measurement in psychological distress at baseline assessment (time frame: baseline assessment (before PM+)). The study lists 3 primary outcomes in all. 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 NCT03830008, which also lists 11 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 8 Feb 2021.