Post Traumatic Stress Disorder PTSDRELIEFNCT06851884
Effectiveness of Informational and Educational Tools to Improve the Experience of Relatives of ICU Patients. RELIEF, a Platform Trial
A study testing Video capsules, Cartoon and Virtual reality in people with Post Traumatic Stress Disorder PTSD, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Video capsules, Cartoon and Virtual reality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trial 1 :
- Relatives of patients with the following characteristics: ≥18 years old, treated in intensive care with invasive mechanical ventilation for at least 48 hours having received a visit from at least one relative within the first 72 hours.
- ≥18 years old
- Identified, if possible, by the patient as the reference person or person to be informed, or, if the patient is unable to communicate, identified by the healthcare providers as the "patient's reference relative."
- Understanding and speaking French • Having provided their phone contact information Only one relative of the patient is included in the study.
- Trial 2 :
Show all 13Show fewer
- Relatives of patients with the following characteristics: ≥18 years old, having been treated in intensive care with invasive mechanical ventilation for at least 48 hours, for whom a decision of withhold or withdraw treatment has been made with expected death in intensive care.
- ≥18 years old
- Identified, if possible, by the patient as the reference person or person to be informed, or, if the patient is unable to communicate, identified by healthcare providers as the "patient's reference relative."
- Present at the end-of-life conference (announcement of the EOL decision)
- Understanding and speaking French
- Having provided their phone contact information
- Only one relative of the patient is included in the study. They are included just before or just after the end-of-life conference.
Who cannot join
- Patients :
- Planned or considered organ donation
- Detained or deprived of liberty
- Under guardianship or curatorship
- No social security
- Relatives :
Show all 10Show fewer
- Social context making follow-up and telephone interviews difficult (homeless individuals, not residing in Europe or the overseas territories)
- Inability to provide a "stable" personal mobile number (temporary phone number or not in their own name or the name of their spouse/partner)
- Under guardianship or curatorship
- Inability to communicate by phone (hearing impairments, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacité d'Interventions Pour améliorer le vécu Des Proches de Patients hospitalisés en réanimation. RELIEF, un Essai Plateforme
The admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. In addition to these emotions, relatives also struggle to understand the information provided by the medical team-only half of the information is fully understood. These emotional and cognitive difficulties can become obstacles in decision-making processes and may have medium- and long-term consequences on their psychological well-being, particularly in terms of post-traumatic stress disorder (PTSD), anxiety, and depression. Three months after the patient is discharged from the ICU, one-third of relatives exhibit symptoms of PTSD.
The aim of this research is to propose a variety of informational and educational tools to improve relatives' understanding of both the ICU context and the information provided, with the goal of reducing the risk of developing PTSD in the months following the patient's discharge or death.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- Standard of Care (SOC), Video capsules, Cartoon, Virtual reality, Set of "end-of-life and grief" informational and educational tools
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Universal welcome leaflet on patient admission
Video capsulesOther
3 video capsules of 3 minutes each
CartoonOther
3 cartoons
Virtual realityOther
3 virtual reality programs
Set of "end-of-life and grief" informational and educational toolsOther
Including a video capsule, a cartoon, and a kit of two leaflets
Standard of Care (SOC)Other
Universal welcome leaflet on patient admission
| Study group | Role | What they receive |
|---|---|---|
| Trial 1 : Control | Active comparator | Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice Receives: Other: Standard of Care (SOC) |
| Trial 1 : Video Capsule arm | Experimental | Not described Receives: Other: Video capsules |
| Trial 1 : Cartoon arm | Experimental | Not described Receives: Other: Cartoon |
| Trial 1 : Virtual reality arm | Experimental | Not described Receives: Other: Virtual reality |
| Trial 2 : Control | Active comparator | Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice Receives: Other: Standard of Care (SOC) |
| Trial 2 : set of "end-of-life and grief" informational and educational tools | Experimental | Not described Receives: Other: Set of "end-of-life and grief" informational and educational tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Disorder (PTSD)
Assessed with PCL-5 scale three months after the patient's discharge or death. The PCL-5 scale, Post-traumatic stress disorder CheckList version DSM-5 (PCL-5) [PCL-5, 8/14/2013, Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr - National Center for PTSD] includes 20 items addressing PTSD symptoms according to DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely") for a total score between 0 and 80).
Measured: At 3 months
Secondary outcomes (16)
Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care
Measure the impact of each of the 3 sets of informational and educational tools on the overall understanding of relatives in intensive care (diagnosis, prognosis, treatment) at the time of discharge from intensive care (questionnaire)
Measured: Up to 6 months
Trial 1 : Measure the impact of each of the 3 sets of tools on the anxiety and depression symptoms of relatives
Measure the impact of each of the 3 sets of informational and educational tools on the anxiety and depression symptoms of relatives at the time of discharge from intensive care (HADS scale).
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Measured: Up to 6 months
Trial 1 & 2 : Sleep quality of relatives
Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: At inclusion
Trial 1 & 2 : Sleep quality of relatives
Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: At 3 months
Trial 1 & 2 : Sleep quality of relatives
Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: At 6 months
Trial 1 & 2 : Symptoms of post-traumatic dissociation
Evaluated by PDEQ : Post-traumatic Dissociation Questionnaire. Total score ranges from 0 to 48. The higher the score the more severe the dissociation symptoms are.
Measured: At inclusion
Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams
Satisfaction assessed on a 8-step scale regarding communication with intensive care team
Measured: At 3 months
Trial 1 & 2 Post-traumatic stress disorder
Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing post-traumatic stress disorder Trial 2 : Measure the impact of EOL of informational and educational tools on the risk of developing post-traumatic stress disorder
Assessed with PCL-5 scale six months after the patient's discharge or death. The PCL-5 scale, Post-traumatic stress disorder CheckList version DSM-5 (PCL-5) [PCL-5, 8/14/2013, Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr - National Center for PTSD] includes 20 items addressing PTSD symptoms according to DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely") for a total score between 0 and 80).
6 months after the patient's discharge or death
Measured: At 6 months
Trial 1 & 2 : anxiety and depression symptoms of relatives
Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing anxiety and depression symptoms in relatives
Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing anxiety and depression symptoms in relatives
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
3 months after the patient's discharge or death
Measured: At 3 months
Trial 1 & 2 : anxiety and depression symptoms of relatives
Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing anxiety and depression symptoms in relatives
Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing anxiety and depression symptoms in relatives
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
6 months after the patient's discharge or death
Measured: At 6 months
Trial 1 & 2 : Past traumatic experiences
Trauma History Screen (THS) The THS typically asks individuals to respond to a series of yes/no questions about whether they've experienced specific types of trauma. They include : Physical abuse, Sexual abuse, Witnessing violence, Accidents or natural disasters, Military combat, Emotional abuse, Neglect.
The score is the number of traumatic events.
Measured: At 3 months
Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death
Trial 1 : Measure, in bereaved relatives, the impact of informational and educational tools on the risk of developing prolonged grief
Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing prolonged grief
Prolonged Grief Disorder Scale PG-13 The score ranges from 0 to 52. Total scores of 30 or above generally indicate that the individual may be experiencing Prolonged Grief Disorder (PGD) and should be considered for further evaluation.
Lower scores suggest that the individual is not experiencing clinically significant prolonged grief symptom
Measured: At 6 months
Trial 1 & 2 : Consumption of medical care and acts by relatives
Using MEDEC tool (medical care consumption and acts) It summarizes frequency and type of care
Measured: At inclusion
Trial 1 & 2 : Consumption of medical care and acts by relatives
Using MEDEC tool (medical care consumption and acts) It summarizes frequency and type of care
During the 6 months following the patient's discharge or death
Measured: Up to 6 months
Trial 1&2 : Feasability of use of the tool
Trial 1 : Percentage of care provider who were able to hand over the 3 sets of informational and educational tools to the patient's relatives, as well as their satisfaction
Trial 2 : Percentage of care provider who wereable to hand over the EOL informational and educational tools to the patient's relatives, as well as their satisfaction
Measured: Up to 6 months
Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire
self-assessment questionnaire with 14 items
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized platform trial designed to investigate a clinical question across multiple subpopulations and involving multiple interventions. The trials integrated into the platform trial are randomized and may be either conventional trials or adaptive MAMS (Multi-Arms Multi-Stage) trials. These involve multiple arms and phases, allowing for the adaptive evaluation of several interventions, with the possibility of adding or removing interventions during the trial. Additionally, the trials include a hybrid control arm that combines randomized concurrent controls and historical external controls from an observational cohort. Trial 1 : randomization according to a 1:2:2:2 ratio into one of the 4 arms: * Control * Video capsules * Comic strips * Virtual reality Trial 2 : randomization according to a 1:2 ratio into the control or intervention arm (set of "end-of-life and grief" informational and educational tools, including a video capsule, a cartoon, and a kit of 2 leaflets).
- Masking
- None (open label)
- Enrolment
- 562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851884
- Sponsor's protocol ID
- APHP240666
- Acronym
- RELIEF
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacité d'Interventions Pour améliorer le vécu Des Proches de Patients hospitalisés en réanimation. RELIEF, un Essai Plateforme
- ClinicalTrials.gov ID
- NCT06851884
- Acronym / sponsor ID
- RELIEF / APHP240666
- Conditions
- Post Traumatic Stress Disorder PTSD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Feb 2025 (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 admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. In addition to these emotions, relatives also struggle to understand the information provided by the medical team-only half of the information is fully understood. These emotional and cognitive difficulties can become obstacles in decision-making processes and may have medium- and long-term consequences on their psychological well-being, particularly in terms of post-traumatic stress disorder (PTSD), anxiety, and depression. Three months after the patient is discharged from the ICU, one-third of relatives exhibit symptoms of PTSD.
The aim of this research is to propose a variety of informational and educational tools to improve relatives' understanding of both the ICU context and the information provided, with the goal of reducing the risk of developing PTSD in the months following the patient's discharge or death.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized platform trial designed to investigate a clinical question across multiple subpopulations and involving multiple interventions. The trials integrated into the platform trial are randomized and may be either conventional trials or adaptive MAMS (Multi-Arms Multi-Stage) trials. These involve multiple arms and phases, allowing for the adaptive evaluation of several interventions, with the possibility of adding or removing interventions during the trial. Additionally, the trials include a hybrid control arm that combines randomized concurrent controls and historical external controls from an observational cohort. Trial 1 : randomization according to a 1:2:2:2 ratio into one of the 4 arms: * Control * Video capsules * Comic strips * Virtual reality Trial 2 : randomization according to a 1:2 ratio into the control or intervention arm (set of "end-of-life and grief" informational and educational tools, including a video capsule, a cartoon, and a kit of 2 leaflets).
| Arm | Type | Receives |
|---|---|---|
| Trial 1 : Control | Active comparator | Other: Standard of Care (SOC)Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice |
| Trial 1 : Video Capsule arm | Experimental | Other: Video capsules |
| Trial 1 : Cartoon arm | Experimental | Other: Cartoon |
| Trial 1 : Virtual reality arm | Experimental | Other: Virtual reality |
| Trial 2 : Control | Active comparator | Other: Standard of Care (SOC)Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice |
| Trial 2 : set of "end-of-life and grief" informational and educational tools | Experimental | Other: Set of "end-of-life and grief" informational and educational tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Relatives of patients with the following characteristics: ≥18 years old, treated in intensive care with invasive mechanical ventilation for at least 48 hours having received a visit from at least one relative within the first 72 hours.
- ≥18 years old
- Identified, if possible, by the patient as the reference person or person to be informed, or, if the patient is unable to communicate, identified by the healthcare providers as the "patient's reference relative."
- Understanding and speaking French • Having provided their phone contact information Only one relative of the patient is included in the study.
- Relatives of patients with the following characteristics: ≥18 years old, having been treated in intensive care with invasive mechanical ventilation for at least 48 hours, for whom a decision of withhold or withdraw treatment has been made with expected death in intensive care.
Key exclusion criteria (10 listed)
- Planned or considered organ donation
- Detained or deprived of liberty
- Under guardianship or curatorship
- No social security
- Social context making follow-up and telephone interviews difficult (homeless individuals, not residing in Europe or the overseas territories)
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 |
|---|---|---|
| Standard of Care (SOC)Universal welcome leaflet on patient admission | Other | Trial 1 : Control |
| Video capsules3 video capsules of 3 minutes each | Other | Trial 1 : Video Capsule arm |
| Cartoon3 cartoons | Other | Trial 1 : Cartoon arm |
| Virtual reality3 virtual reality programs | Other | Trial 1 : Virtual reality arm |
| Set of "end-of-life and grief" informational and educational toolsIncluding a video capsule, a cartoon, and a kit of two leaflets | Other | Trial 2 : set of "end-of-life and grief" informational and educational tools |
| Standard of Care (SOC)Universal welcome leaflet on patient admission | Other | Trial 2 : Control |
Primary outcome
Post-Traumatic Stress Disorder (PTSD)
Time frame: At 3 months
Assessed with PCL-5 scale three months after the patient's discharge or death. The PCL-5 scale, Post-traumatic stress disorder CheckList version DSM-5 (PCL-5) [PCL-5, 8/14/2013, Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr - National Center for PTSD] includes 20 items addressing PTSD symptoms according to DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely") for a total score between 0 and 80).
16 secondary outcomes
Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care
Time frame: Up to 6 months
Trial 1 : Measure the impact of each of the 3 sets of tools on the anxiety and depression symptoms of relatives
Time frame: Up to 6 months
Trial 1 & 2 : Sleep quality of relatives
Time frame: At inclusion
Trial 1 & 2 : Sleep quality of relatives
Time frame: At 3 months
Trial 1 & 2 : Sleep quality of relatives
Time frame: At 6 months
Trial 1 & 2 : Symptoms of post-traumatic dissociation
Time frame: At inclusion
Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams
Time frame: At 3 months
Trial 1 & 2 Post-traumatic stress disorder
Time frame: At 6 months
Trial 1 & 2 : anxiety and depression symptoms of relatives
Time frame: At 3 months
Trial 1 & 2 : anxiety and depression symptoms of relatives
Time frame: At 6 months
Trial 1 & 2 : Past traumatic experiences
Time frame: At 3 months
Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death
Time frame: At 6 months
Trial 1 & 2 : Consumption of medical care and acts by relatives
Time frame: At inclusion
Trial 1 & 2 : Consumption of medical care and acts by relatives
Time frame: Up to 6 months
Trial 1&2 : Feasability of use of the tool
Time frame: Up to 6 months
Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire
Time frame: At 3 months
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 28 Feb 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Video capsules, Cartoon and Virtual reality in people with Post Traumatic Stress Disorder PTSD, run by Assistance Publique - Hôpitaux de Paris.
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 13 inclusion and 10 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Nancy Kentish-Barnes, MD (+33142499421 ext. +33, nancy.kentish@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Stress Disorder (PTSD) (time frame: At 3 months). 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 28 Feb 2025.