PTSDSERVE:IMPACTNCT03615222
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
An observational study of PTSD and Depression, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Depression, Chronic Pain
- How many people
- 377 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans
Who may be able to join
- The inclusion criteria for the longitudinal assessment study are as follows:
- Potential participants include male and female
- English-speaking OEF/OIF/OND Veterans
- Enrolled at CTVHCS or willing to be enrolled for the purpose of participation in this study.
- To be eligible, participants must be
- able to comprehend and sign the informed consent form
Show all 24Show fewer
- able to complete the structured interviews and self-report assessments
- willing to be contacted for follow-up assessments
- For newly enrolled participants:
- given that the investigators have already recruited a large sample of veterans who are reporting relatively little functional impairment, the investigators will require newly enrolled participants to self-report global functional impairment on the WHODAS 2.0 12-item self-report version equivalent to a mean item score of 1.0.
- Although the investigators anticipate being able to meet the recruitment goals, should recruitment prove more challenging than expected, the investigators will remove this inclusion criterion
- deemed stable on psychotropic medications (defined as 3 months on a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor; >1 month on an anxiolytic or beta-blocker; >1 month medication discontinuation or "wash out" for all medications) at the time of the BL assessment
- deemed stable in psychotherapy (3 months stabilization for psychotherapy and 1-month psychotherapy wash-out) at the time of the BL assessment
- These latter two criteria are instated to ensure that symptoms assessed during the baseline assessment are due to any underlying psychiatric condition and not due to the effects of starting or stopping medications and/or psychotherapy.
- Changes in treatment will be permissible during the current study, as this reflects real-world practice
- All changes in medications will be monitored over time, and appropriately covaried, as treatment can have important effects on functioning over time
- Individuals will be eligible to participate with current and lifetime psychiatric diagnoses, with the exception of:
- schizophrenia
- schizophreniform disorder
- schizoaffective disorder
- delusional disorder
- unspecified schizophrenia spectrum/other psychotic disorder, and bipolar disorder
- Additional inclusion criteria specific to the SCD treatment study are:
- Veterans will have a global disability (mean item) score on the WHODAS 2.0 of 1.0, which is 1 SD above the mean of the large non-psychiatric sample of Veterans from SERVE and VA Boston during both of their last 2 assessments
Who cannot join
- Exclusion criteria for the longitudinal assessment study are as follows:
- plan to relocate out of the CTVHCS system within four months of protocol initiation
- meet criteria for a diagnosis of:
- schizophrenia
- schizophreniform disorder
- schizoaffective disorder
Show all 21Show fewer
- delusional disorder
- a manic/hypomanic episode
- report current suicidal or homicidal risk warranting crisis intervention
- report symptoms consistent with severe traumatic brain injury (TBI) that interfere with their ability to complete the consent process or assessment
- i.e., due to ethical concerns about obtaining informed consent and difficulties with completing the structured assessment
- report current non-military related hallucinations or delusions that cause significant distress and/or impairment
- Additional exclusion criteria for the SCD treatment study are:
- recent (1 month) or anticipated change in psycho-pharmacological treatment. Veterans may stay on current medications but will be asked to refrain from changes to the extent possible based on safety
- logistical circumstances that would interfere with study completion
- Presence of a non-alcohol substance use disorder (SUD) deemed to be the primary focus of treatment
- Those with a principal AUD will be eligible.
- Additional diagnoses of non-alcohol SUD are allowed, unless they are deemed the principal focus of treatment.
- Potentially eligible Veterans who score above the clinical cutoff on the DAST will be asked additional questions during the eligibility screening to determine whether they meet criteria for a principal non-alcohol SUD (see phone screen)
- AUD/SUD of sufficient severity that residential, rather than outpatient, treatment is indicated based on potential safety concerns associated with withdrawal.
- This determination will be made by the PI, with consultation from the Veteran's existing treatment providers, as appropriate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504-7451
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, 76711
About this study
Official title: The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims:
Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD.
Read more
To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time.
H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
Read the detailed description
Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD.
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR\&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims:
Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD.
To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time.
H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
- Conditions
- PTSD, Depression, Chronic Pain, Alcohol Use Disorder, Traumatic Brain Injury
- Keywords
- functional impairment, quality of life, Veterans, mindfulness, Acceptance and Commitment Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Chronic Pain, Alcoholism, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SERVE assessment only | Eligible veterans will complete 4 assessments over a two year period of time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Scale
The Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008) is a state-of-the-art suicide assessment for individuals perceived to be at high risk for suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 2011). Values on the intensity of suicidal ideation (e.g., frequency, duration, controllability, deterrents, reasons for ideation) are summed to create a total score; range from 0 to 25, where higher scores indicate higher SI severity.
Measured: Baseline and 24-month
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Self-report assessment of functional disability with total score and 6 domains of functioning: understanding and communicating, mobility, getting along with others, life activities (i.e., work, education, household responsibilities), participation in society, and self-care (Ustun et al., 2010). Both global and specific areas of functioning are crucial in thoroughly understanding functional recovery, as Veterans may function well in one area and have difficulty in another. Moreover, some domains may be affected by contextual factors instead of representing functional capacity (e.g., work functioning in a struggling economy independent of impairment). Means on this measure capture items from all domain subscales and can range from 0 to 3 where higher scores indicate higher levels of disability.
Measured: Baseline, 8-month, 16-month, and 24-month
Clinician Administered NSSI Disorder Index (CANDI)
The Clinician Administered NSSI Disorder Index (CANDI) is a clinical interview that diagnoses Nonsuicidal Self Injury (NSSI) disorder and type and frequency of NSSI. Demonstrated good reliability and validity in prior research. Results report the number of participants that meet for a diagnosis of NSSID.
Measured: Baseline and 24-month
Inventory of Psychosocial Functioning (IPF) - Brief
Self-report measure (Marx et al., 2009; Bovin et al., 2018) of problems in different domains of life (e.g., Romantic Relationships with a Spouse/Partner, Family, Work, Friendships and Socializing, Parenting, Education, and Self-Care). The short version has a .90 correlation with the full 80-item instrument (Co-I Marx, personal communication). Adjusted totals range from 0 to 100 with higher scores indicate greater functional impairment.
Measured: Baseline, 8-month, 16-month, and 24-month
Beck Scale for Suicide Ideation (BSSI)
Widely-used self-report measure of intensity of thoughts and behaviors associated with suicide. Includes 2 additional items that ask about past suicide attempts as well as the level of suicidal intent during the most recent attempt. Prior research shows that endorsement of suicidal thoughts and behaviors can be greater on self-report questionnaires compared to interviews. Total scores range from 0 to 42 where higher scores indicate higher suicidal ideation.
Measured: Baseline and 24-month
Quality of Life Scale
Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in different areas of their life, distinct from health status, (e.g., mate, physical well-being, relationships with others, social, community, and civic activities, personal development and fulfillment, recreation, and independence). Good internal consistency and high test-retest reliability (Burckhardt et al. 2003). Total scores range from 16 to 112 with higher scores indicating greater life satisfaction.
Measured: Baseline, 8-month, 16-month, and 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Suzannah K. Creech, PhD, Principal investigator, Central Texas Veterans Health Care System, Temple, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615222
- Sponsor's protocol ID
- D0304-I
- Acronym
- SERVE:IMPACT
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2018
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon written request by qualified researchers and following institutional guidelines, deidentified data may be shared if the study participant consented to data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility
- ClinicalTrials.gov ID
- NCT03615222
- Acronym / sponsor ID
- SERVE:IMPACT / D0304-I
- Conditions
- PTSD, Depression, Chronic Pain, Alcohol Use Disorder, Traumatic Brain Injury
- Keywords
- functional impairment, quality of life, Veterans, mindfulness, Acceptance and Commitment Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims:
Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD.
To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time.
H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
Detailed description
Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD.
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR\&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims:
Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD.
To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time.
H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERVE assessment only | – | –Eligible veterans will complete 4 assessments over a two year period of time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans
Key inclusion criteria (24 listed)
- Potential participants include male and female
- English-speaking OEF/OIF/OND Veterans
- Enrolled at CTVHCS or willing to be enrolled for the purpose of participation in this study.
- To be eligible, participants must be
- able to comprehend and sign the informed consent form
Key exclusion criteria (21 listed)
- plan to relocate out of the CTVHCS system within four months of protocol initiation
- meet criteria for a diagnosis of:
- report current suicidal or homicidal risk warranting crisis intervention
- report symptoms consistent with severe traumatic brain injury (TBI) that interfere with their ability to complete the consent process or assessment
- report current non-military related hallucinations or delusions that cause significant distress and/or impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Columbia Suicide Scale
Time frame: Baseline and 24-month
The Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008) is a state-of-the-art suicide assessment for individuals perceived to be at high risk for suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 2011). Values on the intensity of suicidal ideation (e.g., frequency, duration, controllability, deterrents, reasons for ideation) are summed to create a total score; range from 0 to 25, where higher scores indicate higher SI severity.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, 8-month, 16-month, and 24-month
Self-report assessment of functional disability with total score and 6 domains of functioning: understanding and communicating, mobility, getting along with others, life activities (i.e., work, education, household responsibilities), participation in society, and self-care (Ustun et al., 2010). Both global and specific areas of functioning are crucial in thoroughly understanding functional recovery, as Veterans may function well in one area and have difficulty in another. Moreover, some domains may be affected by contextual factors instead of representing functional capacity (e.g., work functioning in a struggling economy independent of impairment). Means on this measure capture items from all domain subscales and can range from 0 to 3 where higher scores indicate higher levels of disability.
Clinician Administered NSSI Disorder Index (CANDI)
Time frame: Baseline and 24-month
The Clinician Administered NSSI Disorder Index (CANDI) is a clinical interview that diagnoses Nonsuicidal Self Injury (NSSI) disorder and type and frequency of NSSI. Demonstrated good reliability and validity in prior research. Results report the number of participants that meet for a diagnosis of NSSID.
Inventory of Psychosocial Functioning (IPF) - Brief
Time frame: Baseline, 8-month, 16-month, and 24-month
Self-report measure (Marx et al., 2009; Bovin et al., 2018) of problems in different domains of life (e.g., Romantic Relationships with a Spouse/Partner, Family, Work, Friendships and Socializing, Parenting, Education, and Self-Care). The short version has a .90 correlation with the full 80-item instrument (Co-I Marx, personal communication). Adjusted totals range from 0 to 100 with higher scores indicate greater functional impairment.
Beck Scale for Suicide Ideation (BSSI)
Time frame: Baseline and 24-month
Widely-used self-report measure of intensity of thoughts and behaviors associated with suicide. Includes 2 additional items that ask about past suicide attempts as well as the level of suicidal intent during the most recent attempt. Prior research shows that endorsement of suicidal thoughts and behaviors can be greater on self-report questionnaires compared to interviews. Total scores range from 0 to 42 where higher scores indicate higher suicidal ideation.
Quality of Life Scale
Time frame: Baseline, 8-month, 16-month, and 24-month
Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in different areas of their life, distinct from health status, (e.g., mate, physical well-being, relationships with others, social, community, and civic activities, personal development and fulfillment, recreation, and independence). Good internal consistency and high test-retest reliability (Burckhardt et al. 2003). Total scores range from 16 to 112 with higher scores indicating greater life satisfaction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon written request by qualified researchers and following institutional guidelines, deidentified data may be shared if the study participant consented to data sharing.
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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.
Suzannah K. Creech, PhD principal investigator
Central Texas Veterans Health Care System, Temple, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Depression, run by VA Office of Research and Development at 2 sites 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 24 inclusion and 21 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Columbia Suicide Scale (time frame: Baseline and 24-month). The study lists 6 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 24 Oct 2024.