Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
NCT ID: NCT05927987
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-06-13
2025-12-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Problem Management Plus and care-as-usual
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.
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.
Care-as-usual
Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Imprisoned in a Dutch prison;
* Held on remand;
* Dutch-speaking;
* Elevated levels of psychological distress (K10 \>15);
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Netherlands Institute for the Study of Crime and Law Enforcement (NSCR)
UNKNOWN
VU University of Amsterdam
OTHER
Responsible Party
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Mathilde van Oudenaren
PhD-student
Principal Investigators
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Marit EM Sijbrandij, PhD
Role: PRINCIPAL_INVESTIGATOR
Full professor - Vrije Universiteit Amsterdam
Locations
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Vrije Universiteit Amsterdam
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Mathilde JF van Oudenaren
Role: primary
Anke B Witteveen
Role: backup
References
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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.
Tol 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.
de 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.
Rahman 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.
van 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.
Related Links
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Individual Problem Management Plus manual
Other Identifiers
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PROSPER
Identifier Type: -
Identifier Source: org_study_id