NCT05927987

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

June 13, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

June 13, 2023

Last Update Submit

December 3, 2024

Conditions

Anxiety DisordersPsychological DistressDepressive Disorder

Keywords

Pilot Randomised Controlled TrialPilot RCTPrisonerRemand PrisonerRemand custodyPrisonDutch prisonDutch prisonsPM+Problem Management PlusWHO interventionPsychological DistressAnxiety DisorderDepressive disorderCommon Mental Health problemsCommon Mental Health disorders

Outcome Measures

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.

    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 (5)

  • Preliminary indications of pre to post-effects on symptoms of depression and anxiety

    Measured at baseline (week 0), week 8 and 13 weeks after baseline.

  • Preliminary indications of pre to post-effects on self-identified problems

    Measured at baseline (week 0), week 8 and 13 weeks after baseline.

  • Preliminary indications of pre to post-effects on quality of life

    Measured at baseline (week 0), week 8 and 13 weeks after baseline.

  • Preliminary indications of pre to post-effects on trauma

    Measured at baseline (week 0), week 8 and 13 weeks after baseline.

  • Preliminary indications of pre to post-effects on suicidal vulnerability

    Measured at baseline (week 0), week 8 and 13 weeks after baseline.

Study Arms (2)

Problem Management Plus and care-as-usual

EXPERIMENTAL

The five sessions of PM+ will be delivered by trained master students in clinical psychology on an individual basis. Care-as-usual will not be withheld.

Behavioral: Problem Management Plus (PM+)

Care-as-usual

NO INTERVENTION

Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons.

Interventions

Problem Management Plus (PM+)BEHAVIORAL

Problem 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.

Problem Management Plus and care-as-usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or above;
  • Imprisoned in a Dutch prison;
  • Held on remand;
  • Dutch-speaking;
  • Elevated levels of psychological distress (K10 \>15);

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

RECRUITING

Related Publications (5)

  • Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unutzer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.

    PMID: 22110406BACKGROUND

  • Tol WA, Barbui C, van Ommeren M. Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA. 2013 Aug 7;310(5):477-8. doi: 10.1001/jama.2013.166723. No abstract available.

    PMID: 23925613BACKGROUND

  • de Graaff AM, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJJ, Acarturk C, Bryant R, Burchert S, Dawson KS, Fuhr DC, Hansen P, Jordans M, Knaevelsrud C, McDaid D, Morina N, Moergeli H, Park AL, Roberts B, Ventevogel P, Wiedemann N, Woodward A, Sijbrandij M; STRENGTHS Consortium; STRENGTHS consortium. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023 Feb;26(1):e300637. doi: 10.1136/bmjment-2022-300637. Epub 2023 Feb 8.

    PMID: 36789918BACKGROUND

  • Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

    PMID: 27837602BACKGROUND

  • van Oudenaren MJF, Witteveen AB, Dirkzwager AJE, Sijbrandij M. Acceptability and feasibility of Problem Management Plus to address mental health problems among remand prisoners in the Netherlands: a pilot randomised controlled trial protocol. Health Justice. 2025 May 13;13(1):31. doi: 10.1186/s40352-025-00341-9.

    PMID: 40358872DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

Mental DisordersMood Disorders

Study Officials

  • Marit EM Sijbrandij, PhD

    Full professor - Vrije Universiteit Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde JF van Oudenaren, MSc

CONTACT

+3120-5981272M.J.F.van.Oudenaren@vu.nl

Anke B Witteveen, PhD

CONTACT

A.B.Witteveen@vu.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The participants will know to which group they are to be allocated. The PM+ supervisors, PM+ helpers, and two principal researchers will know which participants are randomised in a specific group. Involved research assistants (the outcome assessors) and the two other involved researchers will not know.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 3, 2023

Study Start

June 13, 2024

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

NL(1)