Anxiety DisordersPROSPERNCT05927987
Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
A study testing Problem Management Plus (PM+) in people with Anxiety Disorders and Psychological Distress, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Psychological Distress, Depressive Disorder
- 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
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jun 2024to 6 May 2026
- 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
- 18 years old or above;
- Imprisoned in a Dutch prison;
- Held on remand;
- Dutch-speaking;
- Elevated levels of psychological distress (K10 >15);
Who cannot join
- Enclosed in a penitentiary psychiatric centre;
- Presents a potential security risk to the research team (PM+ helper and/or research team)
- Acute medical condition;
- Imminent suicide risk or expressed acute needs/protection risks (e.g., someone who expresses that they are at acute risk of being assaulted or killed);
- Severe mental disorder (psychotic disorders, substance dependence) ;
- Severe cognitive impairment (e.g., severe intellectual disability or dementia);
- Currently enrolled in a specialised psychological treatment program (e.g., EMDR, CBT);
- Less than two months on a stable dose of psychotropic medication (if applicable).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial
The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are:
- To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons?
- To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms?
Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.
Read the detailed description
Rationale: Each year between 20 and 30 thousand individuals are newly incarcerated in Dutch prisons. Common mental disorders, such as depression and anxiety, are overrepresented in prison populations. As such, mental health problems are an important target for intervention, since they have been found to be associated with re-offending. The prison period may provide opportunities for addressing mental health problems, but there may be important obstacles and barriers to the actual delivery of interventions, such as a lack of mental health care specialists in prisons due to staff shortages.
Within the PROSPER study, we will evaluate the feasibility and acceptability of implementing the brief, scalable Problem Management Plus (PM+) intervention in Dutch prisons. The PM+ intervention is designed to address common mental health problems, is delivered by trained non-specialists, and will be specifically adapted for the prison setting.
Objective: The primary objective of the PROSPER study is to evaluate the feasibility and acceptability of PM+ adapted for individuals imprisoned in Dutch prisons.
Study design: This study entails a single-blind pilot randomised controlled trial (RCT) (Study Phase 2) and a qualitative study to evaluate the process following the pilot RCT (Study Phase 3).
Study population: Study Phase 2 - Dutch-speaking adults (18 years or older; N=60) who at the time of inclusion are enclosed in a Dutch remand prison and have a remaining sentence length of at least 15 weeks and who report an elevated level of psychological distress (K10 >15). Study Phase 3 - Participants (N= 20) will be from different stakeholder groups: the RCT participants, PM+ helpers, PM+ supervisors/trainers, and professionals. If permitted by RCT participants, family members, and friends are also invited.
Intervention (if applicable): Treatment group (n=30) - Participants in the treatment group will receive care-as-usual (CAU) and five sessions of PM+. PM+ is a brief, evidence-based psychological intervention and will be delivered by trained master students in clinical psychology and supervised by mental health care specialists. Control group (n=30) - This group will receive CAU only.
Main study parameters/endpoints: Main parameters are 1) PM+ fidelity, 2) perceptions about PM+ from stakeholders, 3) indicators of intervention delivery, 4) retention rate PM+ sessions, and 5) recruitment and consent rates. The secondary study parameter will be 1) symptoms of depression and anxiety (PHQ9 and GAD-7), 2) self-identified problems (PSYCHLOPS), 3) daily functioning (WHOQOL-BREF) and 4) symptoms of trauma (PCL-5) and suicidality vulnerability (SCOPE-2).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study Phase 2 - participants enrolled in the treatment group will receive five sixty-minute PM+ sessions. If participants give permission, the sessions will be audiotaped for monitoring purposes. Additionally, all participants will be invited for a total of four assessments (one screening, one baseline assessment, and two post-intervention assessments). The post- intervention assessments will take place one week and three months after the last PM+ session. These assessments, all together, will take approximately 2 hours and 40 minutes. Study Phase 3 - Five stakeholder groups will be invited for individual interviews to evaluate the intervention and process. Each interview will take approximately 1 to 1,5 hours.
- Being tested
- Problem Management Plus (PM+)
- Keywords
- Pilot Randomised Controlled Trial, Pilot RCT, Prisoner, Remand Prisoner, Remand custody, Prison, Dutch prison, Dutch prisons, PM+, Problem Management Plus, WHO intervention, Psychological Distress, Anxiety Disorder, Depressive disorder, Common Mental Health problems, Common Mental Health disorders
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
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, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011; Tol et al., 2013). 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, stress management, behavioural activation, and accessing social support. PM+ has three core features. It is brief (five sessions given in five weeks), delivered by paraprofessionals (PM+ helpers) and transdiagnostic. The PM+ helpers will be supervised by mental health care specialists.
| Study group | Role | What they receive |
|---|---|---|
| Problem Management Plus and care-as-usual | Experimental | The five sessions of PM+ will be delivered by trained master students in clinical psychology on an individual basis. Care-as-usual will not be withheld. Receives: Behavioral: Problem Management Plus (PM+) |
| Care-as-usual | No intervention | Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of PM+
Factors relevant to the study of this outcome are:
- PM+ fidelity;
- The perceptions about PM+ from RCT participants, helpers, supervisors, trainers, professionals, and family members \& friends of RCT participants;
- Indicators of intervention delivery, such as implementation process, adaptation, and dose.
- Retention rate PM+ sessions; and
- Recruitment and the consent rates.
Measured: Outcomes are gathered throughout the study: during (factor 1) and after the trial finished (factors 2, 3, 4 and 5). We estimate inclusion will take about 9 months. Thus these factors will likely be gathered over a time frame of about one year.
Secondary outcomes (5)
Preliminary indications of pre to post-effects on symptoms of depression and anxiety
Measured by Patient Health Questionnaire - 9 (PHQ9, depression) and Generalized Anxiety Disorder-7 (GAD-7, anxiety). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms. A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms.
Measured: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on self-identified problems
Measured by Psychological Outcome Profiles (PSYCHLOPS, self-identified problems). A higher score on the PSYCHLOPS (range = 0 - 20) means a greater severity of self-identified problems.
Measured: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on quality of life
Measured by World Health Organization Quality of Life Scale - brief (WHOQOL-BREF, quality of life). The score range differs per domain, but a higher score on every domain means a higher perceived quality of life. Domain I: 7 - 35. Domain II: 6 - 30. Domain III: 3 - 15. Domain IV: 8 - 40. Facet Overall Quality of Life and Health 2-10.
Measured: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on trauma
Measured by Post Traumatic Stress Disorder Checklist DSM5 (PCL-5, PTSD symptoms). A higher score on the PCL-5 (range = 0 - 80) means a greater severity of PTSD symptoms.
Measured: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on suicidal vulnerability
Measured by Suicide Concerns for Offenders in Prison Environment - 2 (SCOPE-2, suicidal vulnerability). A higher score on the SCOPE-2 (range = 19 - 76) means a greater vulnerability for suicide and non-fatal self-harm behaviour.
Measured: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start13 Jun 2024
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RCT is a parallel-group, two-arm trial with a 1:1 allocation ratio. Participants are imprisoned adults in Dutch remand prisons with elevated levels of psychological distress (K10 \> 15). Participants will be stratified by gender. A total of 60 participants will be included.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Institute for the Study of Crime and Law Enforcement
- Responsible party
- Principal investigator, Mathilde van Oudenaren, VU University of Amsterdam
- Investigators
- Marit EM Sijbrandij, PhD, Principal investigator, Full professor - Vrije Universiteit Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927987
- Sponsor's protocol ID
- PROSPER
- Acronym
- PROSPER
- Status last verified
- May 2026
- First submitted
- 13 Jun 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dua 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 23925613de Graaff AM, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJJ, Acarturk C, Bryant R, Burchert S, Dawson KS, Fuhr DC, Hansen P, Jordans M, Knaevelsrud C, McDaid D, Morina N, Moergeli H, Park AL, Roberts B, Ventevogel P, Wiedemann N, Woodward A, Sijbrandij M; STRENGTHS Consortium; STRENGTHS consortium. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023 Feb;26(1):e300637. doi: 10.1136/bmjment-2022-300637. Epub 2023 Feb 8.
PubMed 36789918Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.
PubMed 27837602van Oudenaren MJF, Witteveen AB, Dirkzwager AJE, Sijbrandij M. Acceptability and feasibility of Problem Management Plus to address mental health problems among remand prisoners in the Netherlands: a pilot randomised controlled trial protocol. Health Justice. 2025 May 13;13(1):31. doi: 10.1186/s40352-025-00341-9.
PubMed 40358872
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05927987
- Acronym / sponsor ID
- PROSPER / PROSPER
- Keywords
- Pilot Randomised Controlled Trial, Pilot RCT, Prisoner, Remand Prisoner, Remand custody, Prison, Dutch prison, Dutch prisons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Netherlands Institute for the Study of Crime and Law Enforcement
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 3 Jul 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 goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are:
- To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons?
- To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms?
Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.
Detailed description
Rationale: Each year between 20 and 30 thousand individuals are newly incarcerated in Dutch prisons. Common mental disorders, such as depression and anxiety, are overrepresented in prison populations. As such, mental health problems are an important target for intervention, since they have been found to be associated with re-offending. The prison period may provide opportunities for addressing mental health problems, but there may be important obstacles and barriers to the actual delivery of interventions, such as a lack of mental health care specialists in prisons due to staff shortages.
Within the PROSPER study, we will evaluate the feasibility and acceptability of implementing the brief, scalable Problem Management Plus (PM+) intervention in Dutch prisons. The PM+ intervention is designed to address common mental health problems, is delivered by trained non-specialists, and will be specifically adapted for the prison setting.
Objective: The primary objective of the PROSPER study is to evaluate the feasibility and acceptability of PM+ adapted for individuals imprisoned in Dutch prisons.
Study design: This study entails a single-blind pilot randomised controlled trial (RCT) (Study Phase 2) and a qualitative study to evaluate the process following the pilot RCT (Study Phase 3).
Study population: Study Phase 2 - Dutch-speaking adults (18 years or older; N=60) who at the time of inclusion are enclosed in a Dutch remand prison and have a remaining sentence length of at least 15 weeks and who report an elevated level of psychological distress (K10 >15). Study Phase 3 - Participants (N= 20) will be from different stakeholder groups: the RCT participants, PM+ helpers, PM+ supervisors/trainers, and professionals. If permitted by RCT participants, family members, and friends are also invited.
Intervention (if applicable): Treatment group (n=30) - Participants in the treatment group will receive care-as-usual (CAU) and five sessions of PM+. PM+ is a brief, evidence-based psychological intervention and will be delivered by trained master students in clinical psychology and supervised by mental health care specialists. Control group (n=30) - This group will receive CAU only.
Main study parameters/endpoints: Main parameters are 1) PM+ fidelity, 2) perceptions about PM+ from stakeholders, 3) indicators of intervention delivery, 4) retention rate PM+ sessions, and 5) recruitment and consent rates. The secondary study parameter will be 1) symptoms of depression and anxiety (PHQ9 and GAD-7), 2) self-identified problems (PSYCHLOPS), 3) daily functioning (WHOQOL-BREF) and 4) symptoms of trauma (PCL-5) and suicidality vulnerability (SCOPE-2).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study Phase 2 - participants enrolled in the treatment group will receive five sixty-minute PM+ sessions. If participants give permission, the sessions will be audiotaped for monitoring purposes. Additionally, all participants will be invited for a total of four assessments (one screening, one baseline assessment, and two post-intervention assessments). The post- intervention assessments will take place one week and three months after the last PM+ session. These assessments, all together, will take approximately 2 hours and 40 minutes. Study Phase 3 - Five stakeholder groups will be invited for individual interviews to evaluate the intervention and process. Each interview will take approximately 1 to 1,5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The RCT is a parallel-group, two-arm trial with a 1:1 allocation ratio. Participants are imprisoned adults in Dutch remand prisons with elevated levels of psychological distress (K10 > 15). Participants will be stratified by gender. A total of 60 participants will be included.
| Arm | Type | Receives |
|---|---|---|
| Problem Management Plus and care-as-usual | Experimental | Behavioral: Problem Management Plus (PM+)The five sessions of PM+ will be delivered by trained master students in clinical psychology on an individual basis. Care-as-usual will not be withheld. |
| Care-as-usual | No intervention | –Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or above;
- Imprisoned in a Dutch prison;
- Held on remand;
- Dutch-speaking;
- Elevated levels of psychological distress (K10 >15);
Key exclusion criteria (8 listed)
- Enclosed in a penitentiary psychiatric centre;
- Presents a potential security risk to the research team (PM+ helper and/or research team)
- Acute medical condition;
- Imminent suicide risk or expressed acute needs/protection risks (e.g., someone who expresses that they are at acute risk of being assaulted or killed);
- Severe mental disorder (psychotic disorders, substance dependence) ;
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, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011; Tol et al., 2013). 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, stress management, behavioural activation, and accessing social support. PM+ has three core features. It is brief (five sessions given in five weeks), delivered by paraprofessionals (PM+ helpers) and transdiagnostic. The PM+ helpers will be supervised by mental health care specialists. | Behavioural | Problem Management Plus and care-as-usual |
Primary outcome
Feasibility and acceptability of PM+
Time frame: Outcomes are gathered throughout the study: during (factor 1) and after the trial finished (factors 2, 3, 4 and 5). We estimate inclusion will take about 9 months. Thus these factors will likely be gathered over a time frame of about one year.
Factors relevant to the study of this outcome are: 1. PM+ fidelity; 2. The perceptions about PM+ from RCT participants, helpers, supervisors, trainers, professionals, and family members \& friends of RCT participants; 3. Indicators of intervention delivery, such as implementation process, adaptation, and dose. 4. Retention rate PM+ sessions; and 5. Recruitment and the consent rates.
5 secondary outcomes
Preliminary indications of pre to post-effects on symptoms of depression and anxiety
Time frame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on self-identified problems
Time frame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on quality of life
Time frame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on trauma
Time frame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Preliminary indications of pre to post-effects on suicidal vulnerability
Time frame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
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 Jul 2026.
- 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 36789918de Graaff AM, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJJ, Acarturk C, Bryant R, Burchert S, Dawson KS, Fuhr DC, Hansen P, Jordans M, Knaevelsrud C, McDaid D, Morina N, Moergeli H, Park AL, Roberts B, Ventevogel P, Wiedemann N, Woodward A, Sijbrandij M; STRENGTHS Consortium; STRENGTHS consortium. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023 Feb;26(1):e300637. doi: 10.1136/bmjment-2022-300637. Epub 2023 Feb 8.
- Background: PubMed 27837602Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.
- Derived from this study: PubMed 40358872van Oudenaren MJF, Witteveen AB, Dirkzwager AJE, Sijbrandij M. Acceptability and feasibility of Problem Management Plus to address mental health problems among remand prisoners in the Netherlands: a pilot randomised controlled trial protocol. Health Justice. 2025 May 13;13(1):31. doi: 10.1186/s40352-025-00341-9.
- Individual Problem Management Plus manualLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety Disorders
Recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
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.
Marit EM Sijbrandij, PhD principal investigator
Full professor - Vrije Universiteit Amsterdam
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 Anxiety Disorders and Psychological Distress, run by VU University of Amsterdam at 1 site in Netherlands.
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 5 inclusion and 8 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 Jul 2026. 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 Netherlands. 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?
Feasibility and acceptability of PM+ (time frame: Outcomes are gathered throughout the study: during (factor 1) and after the trial finished (factors 2, 3, 4 and 5). We estimate inclusion will take about 9 months. Thus these factors will likely be gathered over a time frame of about one year.). 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 NCT05927987, which also lists 5 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 Jul 2026.