The primary aim of this study is to investigate the feasibility, acceptability and user-friendliness of implementing PM+ in Dutch prisons. This is a version of PM+ that is specifically adapted to the prisoner population and prison context. The…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Symptomen van angst, (posttraumatische) stress en depressie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the feasibility and acceptability of PM+
intervention. Factors relevant to that include:
1. PM+ fidelity
2. Perceptions about PM+ from RCT participants, professionals and helpers
3. Indicators of intervention delivery: implementation process, adaptation, and
dose
4. Retention rate PM+ sessions
5. Recruitment and consent rates
Secondary outcome
To assess the preliminary indications of pre to post-effects: 1) Symptoms of
depression and anxiety (PHQ9 and GAD-7), 2) Self-identified problems
(PSYCHLOPS), 3) Daily functioning (WHOQOL-BREF), 4) Symptoms of trauma (PCL-5),
and 5) suicidality vulnerability (SCOPE-2)
Background summary
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.
Study objective
The primary aim of this study is to investigate the feasibility, acceptability
and user-friendliness of implementing PM+ in Dutch prisons. This is a version
of PM+ that is specifically adapted to the prisoner population and prison
context. The secondary goal is to get a first view of the possible pre- to post
effect of PM+ on common mental health symptoms, while taking the sample size
into account.
Study design
The PROSPER study consists of three phases: two qualitative studies (study
phases 1 and 3) and a pilot randomised controlled trial (RCT) (study phase 2).
This proposal concerns study phases 2 and 3. The protocol of phase 1 has
already been approved by the ethics review committee of the Vrije Universiteit
- faculty of behavioural and movements sciences (VCWE) and received a niet-WMO
waiver (reference number: 2022.0393).
Intervention
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.
Study burden and risks
The risks associated with participation are estimated to be minimal, as PM+
reduced common psychological complaints in previous studies in Pakistan, Kenya
and the Netherlands (Bryant et al., 2017; Rahman et al., 2016; de Graaff et
al., 2023), and no significant negative reactions were noted. Participants in
the PM+ intervention group may benefit from their participation through the
potential reduction of psychological symptoms. Also, participants of the
intervention and control group both have access to normal care (CAU).
It is possible that participants experience increased stress during the PM+
sessions (e.g. by talking about stressful events). However, the helpers are
trained, supervised and supervised by experienced psychologists. This allows
them to be able to guide participants during a more difficult moment and to
scale up the care if necessary.
If a participant's mental health does deteriorate during the intervention
period, he can be referred to a specialist in the prison (eg the prison doctor,
psychologist or psychiatrist). The exact procedure will be determined with the
prison in question. The situation of this person will be followed up by the
research team.
Van der Boechorststraat 9
Amsterdam 1081BT
NL
Van der Boechorststraat 9
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in study phase 2, a subject must meet all of the
following criteria: - 18 years old or above; - Imprisoned in a Dutch prison; -
Held on remand; - Dutch-speaking; - Elevated levels of psychological distress
(K10 higher than15). An individual will be eligible to participate in study
phase 3 if: - They were a RCT participant; or - Professionals knowledgeable
about (the mental health of) prisoners; or - Helpers, supervisors or trainers
of the PM+ intervention; or - Family members or friends of RCT participants.
Exclusion criteria
Study phase 2
- 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).
Study phase 3:
- Presents a potential security risk to the research team
- Acute medical condition;
- Imminent suicide risk or expressed acute needs/protection risks.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05927987 |
| CCMO | NL84617.018.23 |