Evaluating a mental health intervention for prisoners in the Netherlands
Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial
This study is testing a new mental health program for prisoners in the Netherlands to see if it can help reduce anxiety and depression better than just regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VU University of Amsterdam Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05927987 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to assess the feasibility and acceptability of the World Health Organization's Problem Management Plus (PM+) intervention, specifically adapted for individuals in Dutch remand prisons. The study will compare two groups: one receiving the PM+ intervention alongside standard care and the other receiving only standard care. Researchers will evaluate the effectiveness of the intervention in reducing symptoms of anxiety and depression among participants. The study also includes a qualitative component to further understand the implementation process.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking adults aged 18 and older who are currently detained in a Dutch remand prison and experiencing elevated psychological distress.
Not a fit: Patients with severe mental disorders, acute medical conditions, or those currently enrolled in specialized psychological treatment programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health outcomes for incarcerated individuals, potentially reducing recidivism rates.
How similar studies have performed: While this approach is novel in the prison context, similar interventions have shown promise in other settings for addressing mental health issues.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Amsterdam
- Vrije Universiteit Amsterdam — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marit EM Sijbrandij, PhD — Full professor - Vrije Universiteit Amsterdam
- Study coordinator: Mathilde JF van Oudenaren, MSc
- Email: M.J.F.van.Oudenaren@vu.nl
- Phone: +3120-5981272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.