NCT05927987 Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
| NCT ID | NCT05927987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VU University of Amsterdam |
| Condition | Anxiety Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-13 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 18 years old or above; * Imprisoned in a Dutch prison; * Held on remand; * Dutch-speaking; * Elevated levels of psychological distress (K10 \>15); Exclusion Criteria: * 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).
Contact & Investigator
Marit EM Sijbrandij, PhD
PRINCIPAL INVESTIGATOR
Full professor - Vrije Universiteit Amsterdam
Frequently Asked Questions
Who can join the NCT05927987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05927987 currently recruiting?
Yes, NCT05927987 is actively recruiting participants. Contact the research team at M.J.F.van.Oudenaren@vu.nl for enrollment information.
Where is the NCT05927987 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05927987 clinical trial?
NCT05927987 is sponsored by VU University of Amsterdam. The principal investigator is Marit EM Sijbrandij, PhD at Full professor - Vrije Universiteit Amsterdam. The trial plans to enroll 60 participants.
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