Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVU University of Amsterdam
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old or above;
Imprisoned in a Dutch prison;
Held on remand;
Dutch-speaking;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Problem Management Plus (PM+)
BehavioralProblem 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Problem Management Plus and care-as-usualExperimental treatment 1 intervention
Group B: Care-as-usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility and acceptability of PM+
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.
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.Secondary outcomes
1
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.
Time frame
Measured at baseline (week 0), week 8 and 13 weeks after baseline.2
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.
Time frame
Measured at baseline (week 0), week 8 and 13 weeks after baseline.3
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.
Time frame
Measured at baseline (week 0), week 8 and 13 weeks after baseline.4
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.
Time frame
Measured at baseline (week 0), week 8 and 13 weeks after baseline.Sponsors and contacts
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VU University of Amsterdam
Lead sponsor
Netherlands Institute for the Study of Crime and Law Enforcement (NSCR)
Collaborator
Source ClinicalTrials.gov