Psychological DistressNCT06404502
Feasibility and Acceptability of PRISMA for Prisoners in Switzerland
A study testing PRISMA in people with Psychological Distress and Anxiety, run by University of Zurich at 1 site in Switzerland.
Trial summary
In response to the significant mental health challenges faced by pretrial detainees, the Swiss Federal Justice Department has initiated a model trial in pretrial detention centres in Zurich and Bern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Anxiety, Depression
- What is being tested?
- PRISMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Dec 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Entering pretrial detention inmate in any of the 11 pretrial detention facilities in the Cantons of Zurich and Bern
- aged ≥ 18 years
Who cannot join
- Not fluently speaking any of the nine languages in which PRISMA is offered: German, Albanian, Arabic, English, French, Italian, Romanian, Serbian/ Croatian, Spanish
- Acute suicidality
- Not interested in PRISMA and its randomized evaluation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich, Canton of Zurich
Naser Morina
About this study
Official title: Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial
In response to the significant mental health challenges faced by pretrial detainees, the Swiss Federal Justice Department has initiated a model trial in pretrial detention centres in Zurich and Bern. This model trial, named in German as a "Modellversuch," is designed to enhance detainees' wellbeing and evaluates various interventions through a randomized controlled trial. The "Prison Stress Management" (PRISMA) programme, a key intervention derived from the WHO's cognitive-behavioral therapy strategies, seeks to address the lack of mental health support within jails.
The goal of this pilot RCT is to evaluate the feasibility and acceptability of PRISMA for inmates inform a full-scale, definitive randomized controlled trial.
Read the detailed description
Given the high prevalence of mental health issues, such as anxiety and depression, in pretrial detainees, the Swiss Federal Justice Department (SFJD) approved a model trial (in German named "Modellversuch Untersuchungshaft", MV). The MV will be carried out in pretrial detention facilities in the cantons of Zurich and Bern and aims to improve the wellbeing and social integration of individuals in pretrial detention. As part of the MV the investigators are evaluating the impact of two interventions using a randomized controlled trial (RCT). The first intervention, "Prison Stress Management" (PRISMA), addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA is a scalable World Health Organization (WHO)-developed psychological intervention based on cognitive-behavioral therapy (CBT) program and goes beyond the status-quo mental health support offered in jails. Currently, only inmates with severe mental health problems are referred to the psychiatric ward of the health services provided in jails and no continuation of support is offered after the transition to the outside world. The second intervention (SOCIAL) uses extended social services to address potential disruptions incarceration might cause in detainees' social and economic lives. The isolation from the outside world implies that detainees might lose their jobs and housing, their relationships with their family and friends are strained, all factor hindering re-integration into society and taxing their mental wellbeing.
The present pilot RCT aims to investigate the feasibility and acceptability of an PRISMA for inmates to inform a full-scale, definitive randomized controlled trial. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, protocol adherence, study visit attendance and the time burden of parent questionnaires. These data will inform the design of a full scale randomized controlled trial to evaluate the efficacy of PRISMA in inmates.
For this purpose only 20 people in each arm will be included.
- Conditions
- Psychological Distress, Anxiety, Depression, Suicidal Ideation
- Being tested
- PRISMA
- Medical subject headings
- Anxiety Disorders, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISMABehavioural
PRISMA has been developed adapting PM+, a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The adapted manual was developed to tailor the sessions to the structure of the Swiss prison system and the needs of inmates of jails in Switzerland. PRISMA involves the following elements: stress management, problem-solving, meaningful activities and relapse prevention
PRISMA has four core features:
- Evidence-based problem-solving strategies
- Brief and easy to learn
- Delivered by lay-helpers ("trainers")
- Transdiagnostic, addressing depression, anxiety, stress, and practical problems as defined by participants;
PRISMA has four sessions.
| Study group | Role | What they receive |
|---|---|---|
| PRISMA | Experimental | The intervention, PRISMA, addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA has been adapted for the context of the model trial from Problem Management Plus (PM+). PRISMA has a total of four sessions provided during the first two weeks after entry such that most inmates can benefit from it before their potential release. The four sessions involve stress management, problem solving, meaningful activities (behavioral activation, and strengthening social support) and relapse prevention (staying well, looking forward). Additionally, participants will receive 2 booster sessions, 4 and 9 weeks after the final session. Receives: Behavioral: PRISMA |
| Control group | No intervention | REGULAR PRETRIAL: participants in this group experience the same pretrial system, conditions, and services that they would have experienced if the RCT did not exist. They will not be offered PRISMA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification procedure to the measurement in psychological distress
The primary outcome is mental health at three weeks as assessed by the scale for depression measured by Patient Health Questionnaire - 9 (PHQ9). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms.
Measured: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
Verification procedure to the measurement in psychological distress
The primary outcome is mental health at three weeks as assessed by the scale for anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms.
Measured: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
Secondary outcomes (2)
Verification procedure to the measurement suicidal ideation
Suicidal Ideation is measured using an adapted version of the Suicidal Ideation Attribution Scale (SIDAS), a brief measure of severity of suicidal ideation assessing frequency, controllability, closeness to attempt, level of distress associated with the thoughts and impact on daily functioning. It consists of 3 items rated on an 11-point scale (0 = "Never" to 10 = "Always").
Measured: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Feasibility of PRISMA by the number of dropouts
Monitoring of the dropouts by number of participants
Measured: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start8 Dec 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pilot RCT will inform us about the feasibility of PRISMA under usual practice conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, The University of New South Wales
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404502
- Sponsor's protocol ID
- BASEC-Nr. 2023-01378-pilot
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06404502
- Acronym / sponsor ID
- BASEC-Nr. 2023-01378-pilot
- Conditions
- Psychological Distress, Anxiety, Depression, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich, The University of New South Wales
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In response to the significant mental health challenges faced by pretrial detainees, the Swiss Federal Justice Department has initiated a model trial in pretrial detention centres in Zurich and Bern. This model trial, named in German as a "Modellversuch," is designed to enhance detainees' wellbeing and evaluates various interventions through a randomized controlled trial. The "Prison Stress Management" (PRISMA) programme, a key intervention derived from the WHO's cognitive-behavioral therapy strategies, seeks to address the lack of mental health support within jails.
The goal of this pilot RCT is to evaluate the feasibility and acceptability of PRISMA for inmates inform a full-scale, definitive randomized controlled trial.
Detailed description
Given the high prevalence of mental health issues, such as anxiety and depression, in pretrial detainees, the Swiss Federal Justice Department (SFJD) approved a model trial (in German named "Modellversuch Untersuchungshaft", MV). The MV will be carried out in pretrial detention facilities in the cantons of Zurich and Bern and aims to improve the wellbeing and social integration of individuals in pretrial detention. As part of the MV the investigators are evaluating the impact of two interventions using a randomized controlled trial (RCT). The first intervention, "Prison Stress Management" (PRISMA), addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA is a scalable World Health Organization (WHO)-developed psychological intervention based on cognitive-behavioral therapy (CBT) program and goes beyond the status-quo mental health support offered in jails. Currently, only inmates with severe mental health problems are referred to the psychiatric ward of the health services provided in jails and no continuation of support is offered after the transition to the outside world. The second intervention (SOCIAL) uses extended social services to address potential disruptions incarceration might cause in detainees' social and economic lives. The isolation from the outside world implies that detainees might lose their jobs and housing, their relationships with their family and friends are strained, all factor hindering re-integration into society and taxing their mental wellbeing.
The present pilot RCT aims to investigate the feasibility and acceptability of an PRISMA for inmates to inform a full-scale, definitive randomized controlled trial. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, protocol adherence, study visit attendance and the time burden of parent questionnaires. These data will inform the design of a full scale randomized controlled trial to evaluate the efficacy of PRISMA in inmates.
For this purpose only 20 people in each arm will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The pilot RCT will inform us about the feasibility of PRISMA under usual practice conditions.
| Arm | Type | Receives |
|---|---|---|
| PRISMA | Experimental | Behavioral: PRISMAThe intervention, PRISMA, addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA has been adapted for the context of the model trial from Problem Management Plus (PM+). PRISMA has a total of four sessions provided during the first two weeks after entry such that most inmates can benefit from it before their potential release. The four sessions involve stress management, problem solving, meaningful activities (behavioral activation, and strengthening social support) and relapse prevention (staying well, looking forward). Additionally, participants will receive 2 booster sessions, 4 and 9 weeks after the final session. |
| Control group | No intervention | –REGULAR PRETRIAL: participants in this group experience the same pretrial system, conditions, and services that they would have experienced if the RCT did not exist. They will not be offered PRISMA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Entering pretrial detention inmate in any of the 11 pretrial detention facilities in the Cantons of Zurich and Bern
- aged ≥ 18 years
Key exclusion criteria (3 listed)
- Not fluently speaking any of the nine languages in which PRISMA is offered: German, Albanian, Arabic, English, French, Italian, Romanian, Serbian/ Croatian, Spanish
- Acute suicidality
- Not interested in PRISMA and its randomized evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISMAPRISMA has been developed adapting PM+, a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The adapted manual was developed to tailor the sessions to the structure of the Swiss prison system and the needs of inmates of jails in Switzerland. PRISMA involves the following elements: stress management, problem-solving, meaningful activities and relapse prevention PRISMA has four core features: * Evidence-based problem-solving strategies * Brief and easy to learn * Delivered by lay-helpers ("trainers") * Transdiagnostic, addressing depression, anxiety, stress, and practical problems as defined by participants; PRISMA has four sessions. | Behavioural | PRISMA |
Primary outcome
Verification procedure to the measurement in psychological distress
Time frame: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
The primary outcome is mental health at three weeks as assessed by the scale for depression measured by Patient Health Questionnaire - 9 (PHQ9). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms.
Verification procedure to the measurement in psychological distress
Time frame: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
The primary outcome is mental health at three weeks as assessed by the scale for anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms.
2 secondary outcomes
Verification procedure to the measurement suicidal ideation
Time frame: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Feasibility of PRISMA by the number of dropouts
Time frame: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISMA in people with Psychological Distress and Anxiety, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naser Morina, PhD (+41 44 255 5280, naser.morina@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verification procedure to the measurement in psychological distress (time frame: Three weeks (primary outcome) after intake; 10 weeks, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.