Clinical trial NCT05927987: Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
Official title: Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Psychological Distress
Depressive Disorder
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
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Netherlands Institute for the Study of Crime and Law Enforcement (NSCR)
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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).

Primary outcomes:
measure: Feasibility and acceptability of PM+
timeFrame: 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:
measure: Preliminary indications of pre to post-effects on symptoms of depression and anxiety
timeFrame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
measure: Preliminary indications of pre to post-effects on self-identified problems
timeFrame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
measure: Preliminary indications of pre to post-effects on quality of life
timeFrame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
measure: Preliminary indications of pre to post-effects on trauma
timeFrame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
measure: Preliminary indications of pre to post-effects on suicidal vulnerability
timeFrame: Measured at baseline (week 0), week 8 and 13 weeks after baseline.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: Full professor - Vrije Universiteit Amsterdam
name: Marit EM Sijbrandij, PhD
role: PRINCIPAL_INVESTIGATOR
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