Trauma and Stress-related DisordersPRESPANCT07427524
MISAPSY: Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults
A study testing Food Assistance and Psychological Follow-Up in people with Trauma and Stress-related Disorders and Food Insecurity, run by University of Lorraine at 6 sites in France.
Trial summary
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Trauma and Stress-related Disorders, Food Insecurity, Child Maltreatment
- What is being tested?
- Food Assistance and Psychological Follow-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Jul 2026to Jun 2027
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be aged 18 to 25 years
- Be supported by a Mission Locale in Paris as part of a social and/or professional integration program
- Voluntarily participate in the study after receiving clear information and signing an informed consent form
- Experiencing severe food insecurity (positive response to item 8 of the FIES)
- Experiencing significant psychological distress, defined by: PHQ-9 score > 15; GAD-7 score > 10
- Have been exposed to at least one adverse childhood experience, identified via the CTQ-SF (Childhood Trauma Questionnaire - Short Form).
Who cannot join
- Being unable to provide informed consent due to impaired comprehension or communication skills
- Currently receiving psychiatric care for an acute or chronic mental illness requiring regular specialized treatment
- Experiencing a social or medical emergency incompatible with the study (e.g., unstable emergency housing, acute suicidal crisis, ongoing hospitalization)
- Being incarcerated, under guardianship or curatorship without specific legal authorization to participate in research
- Having previously participated in a similar study or currently being engaged in a structured psychological intervention protocol
- Having insufficient command of the French language, preventing comprehension of instructions, questionnaires, or interviews.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maud Cappelletti, PhD student contact
6 sites in 1 country
France6 sites
Mission Locale site Centre
Paris, 75011
Mission Locale, +33144938123
Maud Cappelletti, PhD student
Mission Locale site Soleil
Paris, 75013
Mission Locale de Paris, +33145852050
Maud Cappelletti, PhD student
Mission Locale site Avenir
Paris, 75014
Mission Locale de Paris, +33140527730
Maud Cappelletti, PhD student
Mission Locale site Milord
Paris, 75018
Mission Locale de Paris, +33144850118
Maud Cappelletti, PhD student
Mission Locale site Est
Paris, 75019
+33153728140
Maud Cappelletti, PhD student
Mission Locale site Pyrénées
Paris, 75020
Missions Locales de Paris, +33144648610
Maud Cappelletti, PhD student
About this study
Official title: Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale).
Adopting a methodology structured around three complementary components, this study consists of: (1) a cross-sectional survey to identify key associations ; (2) a qualitative study based on semi-structured interviews exploring psychologists' subjective experiences, and (3) a longitudinal comparative interventional study involving two different support programs to assess and compare the impact of these interventions on participants' food insecurity and psychological well-being.
Using a multi-phase design, MISAPSY seeks to move beyond linear risk-factor models by adopting a systemic and network-based approach to mental health and social vulnerability. The study integrates quantitative analyses, including network analyses, qualitative exploration of professional practices, and comparative longitudinal intervention to inform more holistic, equitable, and transferable models of care for vulnerable young adults.
Read the detailed description
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically disadvantaged Young Adults) is a mixed-methods research project designed to deepen the understanding of the interactions between child maltreatment, trauma exposure, food insecurity and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale). This population faces cumulative psychosocial vulnerabilities and remains underrepresented in mental health research. The study addresses this gap by combining quantitative, qualitative, and interventional approaches within a unified and theoretically grounded framework. The study aims to (1) identify key associations and symptom dynamics, (2) explore professional practices and representations of care, and (3) evaluate the effectiveness of integrated support interventions targeting both material and psychological needs.
The study is structured around three complementary research components:
Cross-sectional study: Collection of socio-demographic data and standardized questionnaires to assess child maltreatment, food insecurity, mental health status, resilience, defense mechanisms, substance use, and perceived social support. The data will be analyzed using descriptive and multivariate statistical techniques (R software). Network analyses will be performed.
Qualitative study: Semi-structured interviews will be conducted with psychologists employed at the Mission Locale (Local Youth Employment Center) to support young people. An analysis based on Consensual Qualitative Research will explore individual narratives and better understand the challenges related to the support provided to young people at the Mission Locale. The analyses will be performed using NVivo software.
Longitudinal comparative interventional study: comparison of two care programs. The control group receives weekly food assistance for 12 months. The experimental group receives an intervention combining weekly food assistance for 12 months and twice-monthly psychological follow-up for 6 months. Psychological sessions are delivered by trained psychodynamic psychologists who are partners of the Mission Locale.
Assessments are conducted at 4 timepoints: T0: baseline, T1: 3 months after baseline, T2: 6 months after baseline (end of the psychological intervention phase), and T3: 12 months after baseline (primary endpoint). It will be conducted combining standardized questionnaires and semi-structured interviews to assess the effectiveness of those interventions on participants' psychological distress and food insecurity. The persistence of the therapy's effects (6 months after the end of follow-up) is being investigated.
Data will be analyzed using mixed models and appropriate adjustments for multiple comparisons to assess intervention effectiveness.
By integrating network analysis with a mixed-methods framework, MISAPSY moves beyond linear risk-factor models to capture the dynamic and systemic nature of psychological distress and food insecurity among precarious young adults.
Registry procedures and quality factors include a Quality Assurance Plan (QAP) ensuring data validation, site monitoring, and ethical compliance through adherence to the Committee for the Protection of Persons (CPP) Ile-de-France XI and both Ethics Committees of University of Lorraine and University of Paris Cité; Data Checks \& Source Data Verification through automated validation rules; a Data Dictionary defining all variables, including sources, coding systems (e.g., ICD-10), and reference ranges; and Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, data management, adverse event reporting, and change management to ensure consistency and compliance.
The sample size assessment calls for at least 384 participants for the cross-sectional study to ensure statistical power, 15 participants for the qualitative interviews to achieve data saturation, and 35 participants per group for the longitudinal study (70 in total), with repeated measurements over 12 months to track changes.
The plan for managing missing data incorporates multiple imputation techniques, sensitivity analyses, and reviews of data inconsistencies. The statistical analysis plan includes descriptive analyses for the mean, median, and standard deviations, as well as inferential analyses using logistic regression to identify risk factors, mixed-effects models for intervention outcomes, network analyses to observe the dynamics between symptoms, and thematic coding for the qualitative data analyzed with NVivo software.
- Conditions
- Trauma and Stress-related Disorders, Food Insecurity, Child Maltreatment, Psychological Distress, Depression Symptoms, Anxiety Symptoms
- Being tested
- Food Assistance, Psychological Follow-Up
- Keywords
- Food Insecurity, Mental health, young adults, trauma, adverse childhood experience, psychological distress, precarity, mixed-methods
- Medical subject headings
- Trauma and Stressor Related Disorders, Depression, Anxiety Disorders, Psychological Well-Being, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food AssistanceOther
Weekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity.
Psychological Follow-UpBehavioural
Twice-monthly psychological follow-up sessions provided over a 6-month period, delivered by trained psychodynamic psychologists, aiming to support psychological well-being and address trauma-related psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| Food Assistance Only (Control Group) | Active comparator | Participants in this arm receive weekly food assistance for a duration of 12 months. The food support is intended to address food insecurity. Food distribution takes place within the usual Mission Locale setting. Receives: Other: Food Assistance |
| Food Assistance Plus Psychological Support (Experimental Group) | Experimental | Participants in this arm receive weekly food assistance for 12 months combined with twice-monthly psychological follow-up provided over a 6-month period. The psychological support aims to address psychological distress and trauma-related difficulties in addition to food insecurity. Participants remain in this intervention arm throughout the study, with repeated assessments conducted over a 12-month follow-up period. Psychological support is provided by trained, psychodynamic psychologists who are partners of the Mission Locale. Appointments are held at the young adult's usual Mission Locale location. Receives: Other: Food Assistance; Behavioral: Psychological Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food Insecurity Severity
Food insecurity assessed using the Food Insecurity Experience Scale (FIES), an 8-item standardized questionnaire. The total raw score ranges from 0 to 8, with higher scores indicating greater food insecurity severity. Changes in food insecurity severity over time will be compared between the two intervention arms to evaluate the added impact of psychological support alongside food assistance. The primary outcome is the change in FIES total score from baseline to 12 months (4 assessments), comparing the two intervention arms.
Measured: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study)
Secondary outcomes (3)
Change in Anxiety Symptoms
Anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. The outcome is the change in GAD-7 total score from baseline to 12 months (4 assessments), in both intervention arms.
Measured: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up), and T3: 12 months (end of the study)
Change in Depressive Symptoms
Depressive symptoms assessed using the Patient Health Questionnaire 9-item scale (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. The outcome is the change in PHQ-9 total score from baseline to 12 months (4 assessments), in both intervention arms.
Measured: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
Change in Post-Traumatic Stress Disorder Symptoms
Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD) symptoms assessed using the International Trauma Questionnaire (ITQ), an 18-item self-report questionnaire. 6 items relate to PTSD cluster, 6 items relate to CPTSD cluster and 6 items relate to the Disorders in Self Organization (DSO) cluster. Each symptom item is rated on a 5-point Likert scale ranging from 0 to 4. A symptom is considered present if the score is ≥ 2. The outcome measure is the change in PTSD and CPTSD symptoms status (presence vs absence) from baseline to 12 months (4 assessments), between intervention arms.
Measured: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trauma and Stress-related DisordersStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group interventional design in which participants are randomized (1:1) using a simple randomization sequence. Outcome assessors are blinded to group assignment. The investigator who carries out the randomization procedure will be responsible for the assessments (questionnaires and semi-structured interviews). The control group receives weekly food assistance for 12 months, while the experimental group receives the same food assistance combined with twice-monthly psychological sessions for 6 months. Participants remain in their assigned group throughout the study, with repeated assessments conducted at predefined time points to evaluate changes in food insecurity and psychological well-being (T0: baseline; T1: 3 months after baseline; T2: 6 months after baseline; T3: 12 months after baseline, end of the study). The psychologists who carry out the follow-ups are partners of the Mission Locale but are not part of the research team.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aziz Essadek, PhD, Principal investigator, Université de Paris Cité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427524
- Sponsor's protocol ID
- 2025-A01928-41
- Acronym
- PRESPA
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) containing directly identifiable information will not be shared outside the study team. All data will be pseudonymized prior to analysis, and only fully anonymized datasets will be made available. Access to these anonymized data may be granted to collaborating researchers for secondary analyses, subject to data protection regulations, ethical approvals, and data-sharing agreements ensuring confidentiality and appropriate use.
Publications
Essadek A, Guenoun T, Gressier F, Najdini M, Cappelletti M, Frigaux A, Melchior M, Musso M, Robin M. Post-pandemic changes in anxiety and depression symptom networks among socioeconomically disadvantaged young Adults: A repeated cross-sectional study. SSM Popul Health. 2025 Aug 16;31:101854. doi: 10.1016/j.ssmph.2025.101854. eCollection 2025 Sep.
PubMed 40893605Essadek A, Shadili G, Bergami Goulart Barbosa P, Assous A, Widart F, Payan S, Rabeyron T, Corruble E, Falissard B, Gressier F. Precarious Young Adults' Mental Health during the Pandemic: The Major Impact of Food Insecurity Independently of COVID-19 Diagnosis. Nutrients. 2023 Jul 24;15(14):3260. doi: 10.3390/nu15143260.
PubMed 37513678Pourmotabbed A, Moradi S, Babaei A, Ghavami A, Mohammadi H, Jalili C, Symonds ME, Miraghajani M. Food insecurity and mental health: a systematic review and meta-analysis. Public Health Nutr. 2020 Jul;23(10):1778-1790. doi: 10.1017/S136898001900435X. Epub 2020 Mar 16.
PubMed 32174292Guedeney A, Benamozig G, El Asmar K, Viaux Savelon S. Les jeunes des Missions locales de Paris et le risque suicidaire. Résultats préliminaires d'un essai contrôlé de proposition de suivi psychothérapeutique préventif du suicide (MLADO). Bulletin de l'Académie Nationale de Médecine. 1 juin 2023;207(6):779 86.
Cappelletti M, Mathieu J, Musso M, Shadili G, Bernateau I, Bazan A, Robin M, Essadek A. MISAPSY: childhood maltreatment, food insecurity, psychological distress and professional integration among socioeconomically disadvantaged young adults - a mixed-methods study protocol. BMC Psychol. 2026 Mar 13;14(1):576. doi: 10.1186/s40359-026-04292-0.
PubMed 41821102
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity
- ClinicalTrials.gov ID
- NCT07427524
- Acronym / sponsor ID
- PRESPA / 2025-A01928-41
- Conditions
- Trauma and Stress-related Disorders, Food Insecurity, Child Maltreatment, Psychological Distress, Depression Symptoms, Anxiety Symptoms
- Keywords
- Food Insecurity, Mental health, young adults, trauma, adverse childhood experience, psychological distress, precarity, mixed-methods
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale).
Adopting a methodology structured around three complementary components, this study consists of: (1) a cross-sectional survey to identify key associations ; (2) a qualitative study based on semi-structured interviews exploring psychologists' subjective experiences, and (3) a longitudinal comparative interventional study involving two different support programs to assess and compare the impact of these interventions on participants' food insecurity and psychological well-being.
Using a multi-phase design, MISAPSY seeks to move beyond linear risk-factor models by adopting a systemic and network-based approach to mental health and social vulnerability. The study integrates quantitative analyses, including network analyses, qualitative exploration of professional practices, and comparative longitudinal intervention to inform more holistic, equitable, and transferable models of care for vulnerable young adults.
Detailed description
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically disadvantaged Young Adults) is a mixed-methods research project designed to deepen the understanding of the interactions between child maltreatment, trauma exposure, food insecurity and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale). This population faces cumulative psychosocial vulnerabilities and remains underrepresented in mental health research. The study addresses this gap by combining quantitative, qualitative, and interventional approaches within a unified and theoretically grounded framework. The study aims to (1) identify key associations and symptom dynamics, (2) explore professional practices and representations of care, and (3) evaluate the effectiveness of integrated support interventions targeting both material and psychological needs.
The study is structured around three complementary research components:
Cross-sectional study: Collection of socio-demographic data and standardized questionnaires to assess child maltreatment, food insecurity, mental health status, resilience, defense mechanisms, substance use, and perceived social support. The data will be analyzed using descriptive and multivariate statistical techniques (R software). Network analyses will be performed.
Qualitative study: Semi-structured interviews will be conducted with psychologists employed at the Mission Locale (Local Youth Employment Center) to support young people. An analysis based on Consensual Qualitative Research will explore individual narratives and better understand the challenges related to the support provided to young people at the Mission Locale. The analyses will be performed using NVivo software.
Longitudinal comparative interventional study: comparison of two care programs. The control group receives weekly food assistance for 12 months. The experimental group receives an intervention combining weekly food assistance for 12 months and twice-monthly psychological follow-up for 6 months. Psychological sessions are delivered by trained psychodynamic psychologists who are partners of the Mission Locale.
Assessments are conducted at 4 timepoints: T0: baseline, T1: 3 months after baseline, T2: 6 months after baseline (end of the psychological intervention phase), and T3: 12 months after baseline (primary endpoint). It will be conducted combining standardized questionnaires and semi-structured interviews to assess the effectiveness of those interventions on participants' psychological distress and food insecurity. The persistence of the therapy's effects (6 months after the end of follow-up) is being investigated.
Data will be analyzed using mixed models and appropriate adjustments for multiple comparisons to assess intervention effectiveness.
By integrating network analysis with a mixed-methods framework, MISAPSY moves beyond linear risk-factor models to capture the dynamic and systemic nature of psychological distress and food insecurity among precarious young adults.
Registry procedures and quality factors include a Quality Assurance Plan (QAP) ensuring data validation, site monitoring, and ethical compliance through adherence to the Committee for the Protection of Persons (CPP) Ile-de-France XI and both Ethics Committees of University of Lorraine and University of Paris Cité; Data Checks \& Source Data Verification through automated validation rules; a Data Dictionary defining all variables, including sources, coding systems (e.g., ICD-10), and reference ranges; and Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, data management, adverse event reporting, and change management to ensure consistency and compliance.
The sample size assessment calls for at least 384 participants for the cross-sectional study to ensure statistical power, 15 participants for the qualitative interviews to achieve data saturation, and 35 participants per group for the longitudinal study (70 in total), with repeated measurements over 12 months to track changes.
The plan for managing missing data incorporates multiple imputation techniques, sensitivity analyses, and reviews of data inconsistencies. The statistical analysis plan includes descriptive analyses for the mean, median, and standard deviations, as well as inferential analyses using logistic regression to identify risk factors, mixed-effects models for intervention outcomes, network analyses to observe the dynamics between symptoms, and thematic coding for the qualitative data analyzed with NVivo software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group interventional design in which participants are randomized (1:1) using a simple randomization sequence. Outcome assessors are blinded to group assignment. The investigator who carries out the randomization procedure will be responsible for the assessments (questionnaires and semi-structured interviews). The control group receives weekly food assistance for 12 months, while the experimental group receives the same food assistance combined with twice-monthly psychological sessions for 6 months. Participants remain in their assigned group throughout the study, with repeated assessments conducted at predefined time points to evaluate changes in food insecurity and psychological well-being (T0: baseline; T1: 3 months after baseline; T2: 6 months after baseline; T3: 12 months after baseline, end of the study). The psychologists who carry out the follow-ups are partners of the Mission Locale but are not part of the research team.
| Arm | Type | Receives |
|---|---|---|
| Food Assistance Only (Control Group) | Active comparator | Other: Food AssistanceParticipants in this arm receive weekly food assistance for a duration of 12 months. The food support is intended to address food insecurity. Food distribution takes place within the usual Mission Locale setting. |
| Food Assistance Plus Psychological Support (Experimental Group) | Experimental | Other: Food Assistance, Behavioral: Psychological Follow-UpParticipants in this arm receive weekly food assistance for 12 months combined with twice-monthly psychological follow-up provided over a 6-month period. The psychological support aims to address psychological distress and trauma-related difficulties in addition to food insecurity. Participants remain in this intervention arm throughout the study, with repeated assessments conducted over a 12-month follow-up period. Psychological support is provided by trained, psychodynamic psychologists who are partners of the Mission Locale. Appointments are held at the young adult's usual Mission Locale location. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be aged 18 to 25 years
- Be supported by a Mission Locale in Paris as part of a social and/or professional integration program
- Voluntarily participate in the study after receiving clear information and signing an informed consent form
- Experiencing severe food insecurity (positive response to item 8 of the FIES)
- Experiencing significant psychological distress, defined by: PHQ-9 score > 15; GAD-7 score > 10
Key exclusion criteria (6 listed)
- Being unable to provide informed consent due to impaired comprehension or communication skills
- Currently receiving psychiatric care for an acute or chronic mental illness requiring regular specialized treatment
- Experiencing a social or medical emergency incompatible with the study (e.g., unstable emergency housing, acute suicidal crisis, ongoing hospitalization)
- Being incarcerated, under guardianship or curatorship without specific legal authorization to participate in research
- Having previously participated in a similar study or currently being engaged in a structured psychological intervention protocol
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 |
|---|---|---|
| Food AssistanceWeekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity. | Other | Food Assistance Only (Control Group), Food Assistance Plus Psychological Support (Experimental Group) |
| Psychological Follow-UpTwice-monthly psychological follow-up sessions provided over a 6-month period, delivered by trained psychodynamic psychologists, aiming to support psychological well-being and address trauma-related psychological distress. | Behavioural | Food Assistance Plus Psychological Support (Experimental Group) |
Primary outcome
Change in Food Insecurity Severity
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study)
Food insecurity assessed using the Food Insecurity Experience Scale (FIES), an 8-item standardized questionnaire. The total raw score ranges from 0 to 8, with higher scores indicating greater food insecurity severity. Changes in food insecurity severity over time will be compared between the two intervention arms to evaluate the added impact of psychological support alongside food assistance. The primary outcome is the change in FIES total score from baseline to 12 months (4 assessments), comparing the two intervention arms.
3 secondary outcomes
Change in Anxiety Symptoms
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up), and T3: 12 months (end of the study)
Change in Depressive Symptoms
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
Change in Post-Traumatic Stress Disorder Symptoms
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
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 5 May 2026.
- Background: PubMed 40893605Essadek A, Guenoun T, Gressier F, Najdini M, Cappelletti M, Frigaux A, Melchior M, Musso M, Robin M. Post-pandemic changes in anxiety and depression symptom networks among socioeconomically disadvantaged young Adults: A repeated cross-sectional study. SSM Popul Health. 2025 Aug 16;31:101854. doi: 10.1016/j.ssmph.2025.101854. eCollection 2025 Sep.
- Background: PubMed 37513678Essadek A, Shadili G, Bergami Goulart Barbosa P, Assous A, Widart F, Payan S, Rabeyron T, Corruble E, Falissard B, Gressier F. Precarious Young Adults' Mental Health during the Pandemic: The Major Impact of Food Insecurity Independently of COVID-19 Diagnosis. Nutrients. 2023 Jul 24;15(14):3260. doi: 10.3390/nu15143260.
- Background: PubMed 32174292Pourmotabbed A, Moradi S, Babaei A, Ghavami A, Mohammadi H, Jalili C, Symonds ME, Miraghajani M. Food insecurity and mental health: a systematic review and meta-analysis. Public Health Nutr. 2020 Jul;23(10):1778-1790. doi: 10.1017/S136898001900435X. Epub 2020 Mar 16.
- BackgroundGuedeney A, Benamozig G, El Asmar K, Viaux Savelon S. Les jeunes des Missions locales de Paris et le risque suicidaire. Résultats préliminaires d'un essai contrôlé de proposition de suivi psychothérapeutique préventif du suicide (MLADO). Bulletin de l'Académie Nationale de Médecine. 1 juin 2023;207(6):779 86.
- Derived from this study: PubMed 41821102Cappelletti M, Mathieu J, Musso M, Shadili G, Bernateau I, Bazan A, Robin M, Essadek A. MISAPSY: childhood maltreatment, food insecurity, psychological distress and professional integration among socioeconomically disadvantaged young adults - a mixed-methods study protocol. BMC Psychol. 2026 Mar 13;14(1):576. doi: 10.1186/s40359-026-04292-0.
- This activity report provides institutional background information on the Mission Locale de Paris and the beginnings of the MISAPSY projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) containing directly identifiable information will not be shared outside the study team. All data will be pseudonymized prior to analysis, and only fully anonymized datasets will be made available. Access to these anonymized data may be granted to collaborating researchers for secondary analyses, subject to data protection regulations, ethical approvals, and data-sharing agreements ensuring confidentiality and appropriate use.
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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.
Maud Cappelletti, PhD student contact
Aziz Essadek, PhD principal investigator
Université de Paris Cité
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Assistance and Psychological Follow-Up in people with Trauma and Stress-related Disorders and Food Insecurity, run by University of Lorraine at 6 sites in France.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Contact Aziz ESSADEK, PhD (+33667344173, aziz.essadek@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Food Insecurity Severity (time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study)). 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 NCT07427524, which also lists 5 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 5 May 2026.