Posttraumatic Stress Disorder (PTSD)MSC for PTSDNCT06646692
Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
A study testing Mindful Self Compassion and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Anxiety, Depression - Major Depressive Disorder
- What is being tested?
- Mindful Self Compassion and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2024to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identifies as woman
- Age 18 and over
- Probable PTSD as judged by the PCL-5 (score of 31 or higher, indicated as having optimal signal detection)
- No cognitive impairment according to a score of < 10 on the Short-Blessed Test
- Experienced homelessness in the past 6 months or prior to incarceration ("spent night in public or private shelter or on the street")
- Able to speak and understand English.
Who cannot join
- Not able to speak English
- Judged to be cognitively impaired, as indicated by score > 10 on the Short-Blessed Screener
- Does not meet other inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Comorbidity between PTSD and SUD (PTSD/SUD) is common and frequently co-occurs with other mental health ailments including depression, anxiety, and suicidality. Comorbidity may be amplified in groups vulnerable to high trauma exposure, such as women with low socioeconomic status including women experiencing homelessness (WEH). Moreover, the reciprocal nature of PTSD/SUD (substances are used to cope with PTSD symptoms; substance use can create high-risk situations for new traumas to occur), can create a cycle of trauma and symptomatology leading to a critical health disparity.
PTSD/SUD can be costly and difficult to treat, with treatment completion often low and relapse rates often high. Low-cost, complementary interventions, such as self-compassion (SC) interventions, which target key mechanisms that maintain PTSD/SUD, could improve treatment outcomes. SC interventions include practices that build skills to improve emotional responses, cognitive understanding, and mindfulness. Recent research supports the benefit of SC interventions for reducing PTSD, SUD, and related comorbidities, potentially with large effects. However, sample sizes have generally been small and randomized designs infrequently used. Moreover, while SC interventions may act to improve key mechanisms of treatment response and/or symptom maintenance (e.g., emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving), such mediating factors have been underexplored. To address these limitations, the present proposal will implement community-based research principles and use a two phase, mixed-method design to adapt and test a widely used SC intervention (Mindful Self Compassion; MSC) for use with a sample of WEH with PTSD/SUD. The project will be conducted in partnership with a state-funded drug treatment facility that serves women and families experiencing high health disparities.
Read more
Phase I was completed in 2023 and adapted the standard MSC course for use with trauma-exposed WEH with PTSD/SUD using the ADAPT-ITT model, an eight-stage model that engages community partners to increase feasibility and acceptability of interventions for at-risk populations.
Phase II will be an open-label cluster randomized clinical trial (N=202) to test the benefit of the adapted MSC at improving primary (PTSD, substance use) and secondary outcomes (depression, anxiety, hopelessness) among a sample of WEH with PTSD/SUD residing in a residential drug treatment site. MSC (n=101) will be compared to Treatment as Usual (TAU; n=101). WEH in the MSC group will complete a 6-week (six sessions plus a half-day retreat) MSC intervention.
The TAU group will engage in weekly check-ins with the research team but will not receive an intervention. WEH will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up. One-on-one interviews will be conducted with the MSC group to collect qualitative data on experiences. An exploratory aim will be to elucidate mechanism of treatment-response and maintenance or remission of PTSD symptoms. These potential mechanisms will include SC, emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving.
Results may inform treatment for PTSD/SUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSD/SUD symptoms over time. Findings are relevant to military populations, which experience high rates of PTSD/SUD, and other populations disproportionately exposed to trauma.
- Being tested
- Mindful Self Compassion, Treatment as Usual (TAU)
- Keywords
- homelessness, mindful self compassion, depression, substance use disorder, craving, PTSD, posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self CompassionBehavioural
Also called MSC
(MSC) is a mind-body integrative health intervention that utilizes meditations, other contemplative practices, home practices, and experiential exercises (including group discussions) to increase SC. MSC can be done in groups of 10-25. To increase feasibility of MSC for use in residential drug treatment facilities, we will aim to adapt MSC to 7 sessions (6 weekly sessions in alignment with the MSC short course plus the half day retreat included in the full course to facilitate skill consolidation). Sessions will be conducted in a group-based format: prior research found group-based formats equivalent to individual-level interventions for PTSD/SUD.
Treatment as Usual (TAU)Behavioural
Also called TAU
Selecting appropriate attention control groups for behavioral intervention research, particularly for mindfulness-based interventions, can be problematic. Comparator groups often also improve as they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). After weighing the pros and cons, a "treatment as usual" (TAU) approach was selected, whereby the MSC will be compared to TAU. However, to control for the confound of weekly compensation, TAU participants will meet with study staff seven times over the 6-week period and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes surveys) in exchange for compensation commensurate with the MSC group. We believe this will also help with retention of the TAU group over time and strike an appropriate balance between controlling for the effects of study participation while minimizing confounds that often occur with active control groups in behavioral trials.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self Compassion Classes | Experimental | (MSC) is a mind-body integrative health intervention that utilizes meditations, other contemplative practices, home practices, and experiential exercises (including group discussions) to increase SC. MSC can be done in groups of 10-25. To increase feasibility of MSC for use in residential drug treatment facilities we will aim to adapt MSC to 7 sessions (6 weekly sessions in alignment with the MSC short course plus the half day retreat included in the full course to facilitate skill consolidation). Sessions will be conducted in a group-based format: prior research found group-based formats equivalent to individual-level interventions for PTSD/SUD. Receives: Behavioral: Mindful Self Compassion |
| Treatment as Usual | Experimental | Selecting appropriate attention control groups for behavioral intervention research, particularly for mindfulness-based interventions, can be problematic. Comparator groups often also improve as they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). After weighing the pros and cons, a "treatment as usual" (TAU) approach was selected, whereby the MSC will be compared to TAU. However, to control for the confound of weekly compensation, TAU participants will meet with study staff seven times over the 6-week period and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes surveys) in exchange for compensation commensurate with the MSC group. We believe this will also help with retention of the TAU group over time and strike an appropriate balance between controlling for the effects of study participation while minimizing confounds that often occur with active control groups in behavioral trials. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
PTSD symptoms will be measured using the PTSD Checklist for Diagnostic and Statistical Manuel of Mental Disorders, DSM-5 (PCL-5), which will be scored continuously and according to diagnostic criteria.2 The PCL-5 initially starts with the identification of the presence of exposure to a Diagnostic and Statistical Manual of Mental Disorders, DSM-V traumatic event; assesses actual or threatened death, serious injury or sexual violence; and whether the person directly experienced it. Twenty additional items assess all four B-E criteria (re-experiencing, avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale from 0 (not at all) to 4 (extremely). Treatment response will be defined as a ≥ 5-point reduction in symptoms and clinically meaningful improvement as ≥ 10-point reduction in symptoms. PTSD will be assessed for worse lifetime event and (if applicable) worst event in the past year.
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is part of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Common Data Elements for use in clinical trials. The Audit is a 10-item alcohol screen that helps identify persons who are hazardous drinkers or who have active alcohol use disorders. It can be calculated as a sum score and will be analyzed as a continuous and categorical (yes/no used alcohol) outcome.
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Drug Abuse Screening Test (DAST)
The DAST is a 10-item brief, self-report instrument for population screening, clinical case finding and treatment evaluation research. It can be used with adults and older youth. The DAST-10 yields a quantitative index of the degree of consequences related to drug abuse. The instrument takes approximately 5 minutes to administer and may be given in either a self-report or interview format. The DAST may be used in a variety of settings to provide a quick index of drug abuse problems. It will be evaluated continuously and as a categorical outcome (yes/no).
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Secondary outcomes (4)
Beck Hopelessness Inventory
This twenty-item measure has been widely used to assess hopelessness through a series of true/false statements (1, 0) that create a sum score.
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Anxiety (PROMIS)
This clinically valid, 7 item measure has been developed as part of the National Institute of Health (NIH) toolkit to assess anxiety in individuals 18 and older. Endpoints range from 1=never to 5=always. It can be used as a sum score and categorizes responses as "none to slight", "mild", "moderate," and "severe".
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Depression (PROMIS)
This clinically valid, 8 item measure has been developed as part of the NIH toolkit to assess depression in the past two weeks. It assesses symptoms ranging from 1=never to 5=always and can be used in individuals 18 and older. It can be used as a sum score and categorizes responses as "none to slight", "mild", "moderate," and "severe".
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Loneliness (PROMIS)
This clinically valid, five item measure was developed as part of the NIH toolkit to assesses feelings of social isolation on a five-point scale from 1=never to 5=not at all.
Measured: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start5 May 2024
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Rose Garfin, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646692
- Sponsor's protocol ID
- 24-000260
- Other IDs
- W911NF-23-1-0208:P00002
- Acronym
- MSC for PTSD
- Status last verified
- May 2026
- First submitted
- 15 Oct 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified, quantitative data will be shared along with a codebook and data dictionary. Data will be completely deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
- ClinicalTrials.gov ID
- NCT06646692
- Acronym / sponsor ID
- MSC for PTSD / 24-000260
- Keywords
- homelessness, mindful self compassion, depression, substance use disorder, craving, PTSD, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 17 Oct 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.
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Comorbidity between PTSD and SUD (PTSD/SUD) is common and frequently co-occurs with other mental health ailments including depression, anxiety, and suicidality. Comorbidity may be amplified in groups vulnerable to high trauma exposure, such as women with low socioeconomic status including women experiencing homelessness (WEH). Moreover, the reciprocal nature of PTSD/SUD (substances are used to cope with PTSD symptoms; substance use can create high-risk situations for new traumas to occur), can create a cycle of trauma and symptomatology leading to a critical health disparity.
PTSD/SUD can be costly and difficult to treat, with treatment completion often low and relapse rates often high. Low-cost, complementary interventions, such as self-compassion (SC) interventions, which target key mechanisms that maintain PTSD/SUD, could improve treatment outcomes. SC interventions include practices that build skills to improve emotional responses, cognitive understanding, and mindfulness. Recent research supports the benefit of SC interventions for reducing PTSD, SUD, and related comorbidities, potentially with large effects. However, sample sizes have generally been small and randomized designs infrequently used. Moreover, while SC interventions may act to improve key mechanisms of treatment response and/or symptom maintenance (e.g., emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving), such mediating factors have been underexplored. To address these limitations, the present proposal will implement community-based research principles and use a two phase, mixed-method design to adapt and test a widely used SC intervention (Mindful Self Compassion; MSC) for use with a sample of WEH with PTSD/SUD. The project will be conducted in partnership with a state-funded drug treatment facility that serves women and families experiencing high health disparities.
Phase I was completed in 2023 and adapted the standard MSC course for use with trauma-exposed WEH with PTSD/SUD using the ADAPT-ITT model, an eight-stage model that engages community partners to increase feasibility and acceptability of interventions for at-risk populations.
Phase II will be an open-label cluster randomized clinical trial (N=202) to test the benefit of the adapted MSC at improving primary (PTSD, substance use) and secondary outcomes (depression, anxiety, hopelessness) among a sample of WEH with PTSD/SUD residing in a residential drug treatment site. MSC (n=101) will be compared to Treatment as Usual (TAU; n=101). WEH in the MSC group will complete a 6-week (six sessions plus a half-day retreat) MSC intervention.
The TAU group will engage in weekly check-ins with the research team but will not receive an intervention. WEH will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up. One-on-one interviews will be conducted with the MSC group to collect qualitative data on experiences. An exploratory aim will be to elucidate mechanism of treatment-response and maintenance or remission of PTSD symptoms. These potential mechanisms will include SC, emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving.
Results may inform treatment for PTSD/SUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSD/SUD symptoms over time. Findings are relevant to military populations, which experience high rates of PTSD/SUD, and other populations disproportionately exposed to trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self Compassion Classes | Experimental | Behavioral: Mindful Self Compassion(MSC) is a mind-body integrative health intervention that utilizes meditations, other contemplative practices, home practices, and experiential exercises (including group discussions) to increase SC. MSC can be done in groups of 10-25. To increase feasibility of MSC for use in residential drug treatment facilities we will aim to adapt MSC to 7 sessions (6 weekly sessions in alignment with the MSC short course plus the half day retreat included in the full course to facilitate skill consolidation). Sessions will be conducted in a group-based format: prior research found group-based formats equivalent to individual-level interventions for PTSD/SUD. |
| Treatment as Usual | Experimental | Behavioral: Treatment as Usual (TAU)Selecting appropriate attention control groups for behavioral intervention research, particularly for mindfulness-based interventions, can be problematic. Comparator groups often also improve as they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). After weighing the pros and cons, a "treatment as usual" (TAU) approach was selected, whereby the MSC will be compared to TAU. However, to control for the confound of weekly compensation, TAU participants will meet with study staff seven times over the 6-week period and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes surveys) in exchange for compensation commensurate with the MSC group. We believe this will also help with retention of the TAU group over time and strike an appropriate balance between controlling for the effects of study participation while minimizing confounds that often occur with active control groups in behavioral trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identifies as woman
- Age 18 and over
- Probable PTSD as judged by the PCL-5 (score of 31 or higher, indicated as having optimal signal detection)
- No cognitive impairment according to a score of < 10 on the Short-Blessed Test
- Experienced homelessness in the past 6 months or prior to incarceration ("spent night in public or private shelter or on the street")
Key exclusion criteria (3 listed)
- Not able to speak English
- Judged to be cognitively impaired, as indicated by score > 10 on the Short-Blessed Screener
- Does not meet other inclusion criteria
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 |
|---|---|---|
| Mindful Self CompassionAlso: MSC(MSC) is a mind-body integrative health intervention that utilizes meditations, other contemplative practices, home practices, and experiential exercises (including group discussions) to increase SC. MSC can be done in groups of 10-25. To increase feasibility of MSC for use in residential drug treatment facilities, we will aim to adapt MSC to 7 sessions (6 weekly sessions in alignment with the MSC short course plus the half day retreat included in the full course to facilitate skill consolidation). Sessions will be conducted in a group-based format: prior research found group-based formats equivalent to individual-level interventions for PTSD/SUD. | Behavioural | Mindful Self Compassion Classes |
| Treatment as Usual (TAU)Also: TAUSelecting appropriate attention control groups for behavioral intervention research, particularly for mindfulness-based interventions, can be problematic. Comparator groups often also improve as they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). After weighing the pros and cons, a "treatment as usual" (TAU) approach was selected, whereby the MSC will be compared to TAU. However, to control for the confound of weekly compensation, TAU participants will meet with study staff seven times over the 6-week period and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes surveys) in exchange for compensation commensurate with the MSC group. We believe this will also help with retention of the TAU group over time and strike an appropriate balance between controlling for the effects of study participation while minimizing confounds that often occur with active control groups in behavioral trials. | Behavioural | Treatment as Usual |
Primary outcome
PTSD
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
PTSD symptoms will be measured using the PTSD Checklist for Diagnostic and Statistical Manuel of Mental Disorders, DSM-5 (PCL-5), which will be scored continuously and according to diagnostic criteria.2 The PCL-5 initially starts with the identification of the presence of exposure to a Diagnostic and Statistical Manual of Mental Disorders, DSM-V traumatic event; assesses actual or threatened death, serious injury or sexual violence; and whether the person directly experienced it. Twenty additional items assess all four B-E criteria (re-experiencing, avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale from 0 (not at all) to 4 (extremely). Treatment response will be defined as a ≥ 5-point reduction in symptoms and clinically meaningful improvement as ≥ 10-point reduction in symptoms. PTSD will be assessed for worse lifetime event and (if applicable) worst event in the past year.
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
The AUDIT is part of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Common Data Elements for use in clinical trials. The Audit is a 10-item alcohol screen that helps identify persons who are hazardous drinkers or who have active alcohol use disorders. It can be calculated as a sum score and will be analyzed as a continuous and categorical (yes/no used alcohol) outcome.
Drug Abuse Screening Test (DAST)
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
The DAST is a 10-item brief, self-report instrument for population screening, clinical case finding and treatment evaluation research. It can be used with adults and older youth. The DAST-10 yields a quantitative index of the degree of consequences related to drug abuse. The instrument takes approximately 5 minutes to administer and may be given in either a self-report or interview format. The DAST may be used in a variety of settings to provide a quick index of drug abuse problems. It will be evaluated continuously and as a categorical outcome (yes/no).
4 secondary outcomes
Beck Hopelessness Inventory
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Anxiety (PROMIS)
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Depression (PROMIS)
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Loneliness (PROMIS)
Time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified, quantitative data will be shared along with a codebook and data dictionary. Data will be completely deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self Compassion and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Anxiety, run by University of California, Los Angeles at 1 site in United States.
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 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: finished, as of the sponsor's last update on 1 Jun 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD (time frame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.