Psychological DistressPRISMANCT06197711
The Short-term Effects of PRISMA on Mental Health
A study testing PRISMA in people with Psychological Distress and Anxiety, run by University of Zurich at 1 site in Switzerland.
Trial summary
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 ("Modellversuch Untersuchungshaft", MV). 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
- 1,480 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2024to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8006
Naser Morina, PhD, +41442555280, naser.morina@usz.ch
About this study
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 ("Modellversuch Untersuchungshaft", MV). The MV will be carried out in 11 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. This project will provide much needed insights to criminal justice authorities to design detention facilities and the detention experience in ways that empower incarcerated individuals to cope with the disruptions and psychological stress that come along with their detention.
Read the detailed description
The RCT will inform about the effect of PRISMA.
The sample size is determined by the enrollment window (from November 27, 2023 to September 30, 2026). Based on historical data, the investigators expect roughly 5,100 subjects to enter pretrial detention in the cantons of Zurich and Bern during this period.
Of the projected 5'100 people entering pretrial detention during the enrollment window, it is expected that roughly 43% (or 2'194 individuals) will be eligible for PRISMA and roughly 65% (or 3'316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, it is expected that 1'428 individuals (or 28% = 43% of 65%) to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals (= 2'194 - 1'428) will be eligible for PRISMA only (randomization sample A) and 1'888 individuals (= 3'316 - 1'428) for proactive social services only (randomization sample B). 1'018 (= 5'100 - 1'428 - 766 - 1'888) individuals will not be eligible for any of the two interventions. If samples are split with equal probability into experimental groups, the investigators expect the following group sizes:
Randomization sample A:
REGULAR PRETRIAL: 383 PRISMA: 383
Randomization sample B:
REGULAR PRETRIAL: 944 SOCIAL: 944
Randomization sample C:
REGULAR PRETRIAL: 357 PRISMA: 357 SOCIAL: 357 PRISMA \& SOCIAL: 357 For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will be pooled. This leaves N = 1480 participants who will be involved in the RCT (assigned to either receiving the PRISMA intervention (N=740) or control condition (REGULAR PRETRIAL) (N = 740)).
This preregistration focuses on the short-term effects of PRISMA on mental wellbeing and therefore only considers the REGULAR PRETRIAL and PRISMA treatment arms. See "Mental Health Intervention and Social Service in Pretrial Detention" on www.socialscienceregistry.org for preregistration of the other treatment arms.
- Conditions
- Psychological Distress, Anxiety, Depression, Suicidal Ideation
- Being tested
- PRISMA
- Keywords
- PRISMA, psychological intervention, psychological distress, inmates, pretrial detention
- 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 |
|---|---|---|
| Intervention group | 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, when most inmates will already have been released from jail. 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 or extended social services, but they can still access social services upon request as well as medical support through the jails' health services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological distress
The primary outcome is mental health at three weeks as measured by the combined two scales. Subscales can be calculated for depression measured by Patient Health Questionnaire - 9 (PHQ9) and anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). 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.
Measured: Three weeks (primary outcome) after intake; 10 weeks after the intervention
Secondary outcomes (3)
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 after the intervention
Assessing the extent to which the strategies taught in PRISMA are used before and after the study participation with the Reducing Tension Checklist
The outcome is measured with a six-item scale that was developed to assess the extent to which the participants perceive that they use the specific strategies, which are trained during the study intervention. The items are rated on a scale from 0 to 4. Higher scores represent greater usage of the strategies.
Measured: 3 weeks follow-up assessment (after intake)
General Health
Assessment of the general health as assessed with Patient Reported Outcomes Measurement and Information System (PROMIS) with two global physical health items (GPH-2 (Hays et al., 2017). The two items are rated on a 5-point Likert scale from 1 to 5 (range 2-10). Higher scores represent better global health.
Measured: 3 weeks after intake, 10 weeks 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 posted9 Jan 2024
- Study start22 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 RCT will inform about the effect of PRISMA. Of the projected 5'100 people entering pretrial detention during the enrollment window, it is expected that roughly 43% (or 2'194 individuals) will be eligible for PRISMA and roughly 65% (or 3'316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, it is expected that 1'428 individuals to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals will be eligible for PRISMA only and 1'888 individuals for proactive social services only. 1'018 individuals will not be eligible for any of the two interventions. For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will pooled. This leaves N = 1480 participants who will be involved in the RCT (assigned to either receiving the PRISMA intervention (N=740) or control condition (N = 740)).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,480 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
- NCT06197711
- Sponsor's protocol ID
- BASEC-Nr. 2023-01378
- Acronym
- PRISMA
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
PubMed 26407793Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.
PubMed 24612048
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effects of PRISMA on Mental Health
- ClinicalTrials.gov ID
- NCT06197711
- Acronym / sponsor ID
- PRISMA / BASEC-Nr. 2023-01378
- Conditions
- Psychological Distress, Anxiety, Depression, Suicidal Ideation
- Keywords
- PRISMA, psychological intervention, psychological distress, inmates, pretrial detention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,480 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich, The University of New South Wales
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Jan 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.
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 ("Modellversuch Untersuchungshaft", MV). The MV will be carried out in 11 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. This project will provide much needed insights to criminal justice authorities to design detention facilities and the detention experience in ways that empower incarcerated individuals to cope with the disruptions and psychological stress that come along with their detention.
Detailed description
The RCT will inform about the effect of PRISMA.
The sample size is determined by the enrollment window (from November 27, 2023 to September 30, 2026). Based on historical data, the investigators expect roughly 5,100 subjects to enter pretrial detention in the cantons of Zurich and Bern during this period.
Of the projected 5'100 people entering pretrial detention during the enrollment window, it is expected that roughly 43% (or 2'194 individuals) will be eligible for PRISMA and roughly 65% (or 3'316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, it is expected that 1'428 individuals (or 28% = 43% of 65%) to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals (= 2'194 - 1'428) will be eligible for PRISMA only (randomization sample A) and 1'888 individuals (= 3'316 - 1'428) for proactive social services only (randomization sample B). 1'018 (= 5'100 - 1'428 - 766 - 1'888) individuals will not be eligible for any of the two interventions. If samples are split with equal probability into experimental groups, the investigators expect the following group sizes:
Randomization sample A:
REGULAR PRETRIAL: 383 PRISMA: 383
Randomization sample B:
REGULAR PRETRIAL: 944 SOCIAL: 944
Randomization sample C:
REGULAR PRETRIAL: 357 PRISMA: 357 SOCIAL: 357 PRISMA \& SOCIAL: 357 For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will be pooled. This leaves N = 1480 participants who will be involved in the RCT (assigned to either receiving the PRISMA intervention (N=740) or control condition (REGULAR PRETRIAL) (N = 740)).
This preregistration focuses on the short-term effects of PRISMA on mental wellbeing and therefore only considers the REGULAR PRETRIAL and PRISMA treatment arms. See "Mental Health Intervention and Social Service in Pretrial Detention" on www.socialscienceregistry.org for preregistration of the other treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The RCT will inform about the effect of PRISMA. Of the projected 5'100 people entering pretrial detention during the enrollment window, it is expected that roughly 43% (or 2'194 individuals) will be eligible for PRISMA and roughly 65% (or 3'316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, it is expected that 1'428 individuals to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals will be eligible for PRISMA only and 1'888 individuals for proactive social services only. 1'018 individuals will not be eligible for any of the two interventions. For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will pooled. This leaves N = 1480 participants who will be involved in the RCT (assigned to either receiving the PRISMA intervention (N=740) or control condition (N = 740)).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | 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, when most inmates will already have been released from jail. |
| 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 or extended social services, but they can still access social services upon request as well as medical support through the jails' health services. |
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
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
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 | Intervention group |
Primary outcome
Change in psychological distress
Time frame: Three weeks (primary outcome) after intake; 10 weeks after the intervention
The primary outcome is mental health at three weeks as measured by the combined two scales. Subscales can be calculated for depression measured by Patient Health Questionnaire - 9 (PHQ9) and anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). 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.
3 secondary outcomes
Suicidal ideation
Time frame: Screening, 3 weeks follow-up assessment, 10 weeks after the intervention
Assessing the extent to which the strategies taught in PRISMA are used before and after the study participation with the Reducing Tension Checklist
Time frame: 3 weeks follow-up assessment (after intake)
General Health
Time frame: 3 weeks after intake, 10 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 26407793Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 24612048van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.
- Individual participant dataSharing planned: No
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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.
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: looking for participants now, as of the sponsor's last update on 14 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological distress (time frame: Three weeks (primary outcome) after intake; 10 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197711, which also lists 4 linked publications.
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 14 Nov 2024.