Post Traumatic Stress DisorderBPSwSNCT04286165
Brief Peer Supported webSTAIR Compared to Enhanced Wait List
A study testing Brief Peer Supported webSTAIR in people with Post Traumatic Stress Disorder and Depression, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This study will enroll 180 Veterans at a 2:1 ratio where 120 Veterans will be enrolled into a brief transdiagnostic peer supported webSTAIR (BPS webSTAIR) and 60 will be supported into Waitlist. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression, Emotion Regulation
- What is being tested?
- Brief Peer Supported webSTAIR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 28 Sep 2022
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read/write English
- Internet connection allowing stable access to VetsPrevail website
- Have experienced at least one traumatic event (positive on the LEC)
- A score greater than or equal to 3 on the PC-PTSD OR greater than or equal to 2 on the PHQ2 on the screen.
- Enrollment into the webSTAIR study must be completed within two weeks of completing screener/eligibility based on symptoms.
Who cannot join
- Currently receiving a trauma-focused intervention (PE, CPT, EMDR, WET) assessed during baseline
- Being unlikely to benefit from therapy or Telemental health, for example:
- Cognitive difficulties as indicated during baseline assessment.
- Active psychosis as indicated during baseline assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, NC-PTSD, Dissemination and Training Division
Palo Alto, California, 94304
About this study
Official title: A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Enhanced Wait List
This study will enroll 180 Veterans at a 2:1 ratio where 120 Veterans will be enrolled into a brief transdiagnostic peer supported webSTAIR (BPS webSTAIR) and 60 will be supported into Waitlist. The purpose of the study is to assess the efficacy BPS webSTAIR in regard to four outcomes: reduction in PTSD and depression symptoms (measured by the PCL-5 and PHQ-8, respectively) and improvement in emotion regulation and work and social adjustment (measured by the DERS-16 and WSAS, respectively). The active treatment is a 6-session modular treatment that focuses on learning emotion management skills where Particpants will have 10 weeks to complete the treatment. Assessments will occur three times for those in webSTAIR: baseline, post-treatment (10 weeks after randomization) and 8-week follow-up and twice for those on waitlist (baseline and 10 weeks after randomization). It is hypothesized that BPS WebSTAIR will be superior to the Waitlist condition on all four outcomes. Mixed Effects Models will be used to evaluate the outcomes.
Read the detailed description
The purpose of this randomized controlled trial is to assess the efficacy of a brief version of webSTAIR (BPS webSTAIR) supported by peers compared to a waitlist condition (WL). Brief peer supported (BPS) webSTAIR is a 6-module web-based transdiagnostic program that provides skills training in emotion regulation; participants in this condition will be able to contact a Veteran peer trained in the program to obtain general support plus guidance about program use and application of skills.
An 11-module version of webSTAIR with therapist coaching has provided pilot data that the program is effective in reducing symptoms of posttraumatic stress disorder (PTSD) and depression as well as improving emotion regulation and work and social adjustment. Pilot data indicate that initial gains are made in the first 6 sessions. In addition, qualitative interviews with Veterans who have completed the program indicate high satisfaction with these modules. This study will assess whether a shorter version of the treatment (6 rather than 11 modules) and with peer rather than professional coaching will be effective compared to a waitlist condition. The BPS webSTAIR program was developed with the aim of providing a treatment for trauma-related symptoms that is effective, brief, engaging and likely to be completed by the user. The reduction of the number of modules creates a briefer treatment than the investigators current web-based program. In addition, data indicated that integrating Veteran peers into mental health programs leads to better engagement and greater retention providing the rationale for including Veteran peers rather than therapists (e.g., psychologists, social workers). Given the absence of findings that a brief, peer-supported version of webSTAIR provides improvement in the above symptoms, the research team followed recommendations for the development and testing of psychotherapies and used a waitlist control as an initial test of efficacy.
The aim is to establish the efficacy of BPS webSTAIR in improving symptoms of PTSD and depression, emotion regulation problems and work and social adjustment compared to a Waitlist Control.
Hypothesis 1a: Compared to WL, BPS webSTAIR will provide greater improvement in PTSD symptoms as measured by the PCL5 and depression as measured by the PHQ-8 (secondary outcome). Assessments will be made at pre-treatment, post-treatment, and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks from randomization) for WL.
Hypothesis 1b: Compared to WL, BPS webSTAIR will provide greater improvement in emotion regulation as measured by the DERS-16 and overall functioning as measured by the work and social adjustment scale (WSAS) (secondary outcomes). Assessments will be made at pre-treatment, post-treatment and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks after randomization) for WL.
In the BPS webSTAIR condition, participants will first complete a welcome module to orient them to the program. After randomization, participants will have 10 weeks to complete the 6 modules. Every time the Veteran logs on they will have the opportunity to engage with a Veteran peer for support through the web program. Contacts can last for up to an hour. Veterans will receive a series of automated reminders and engagement emails that the Vets Prevail program sends at various points in the program.
The equivalence of the treatment conditions on baseline variables demographics and psychological variables) will be assessed and controlled (if necessary) in the final analyses. Other preliminary analyses will include examination of distributional properties of the measures. Transformations will be used to improve distributions when necessary. Missing data patterns (from missed assessments and from dropout) will be examined and compared between conditions. Mixed Effects Models (MEMs) will be used to evaluate differences between the two treatments over time with time as a main effect and treatment-by-time as an interaction term.
- Being tested
- Brief Peer Supported webSTAIR
- Keywords
- PTSD, Post Traumatic Stress Disorder, Depression, Emotion Regulation, Skills Building, Peer, Coaching, Online
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Peer Supported webSTAIROther
The BPS webSTAIR program is an online platform where individuals are taught skills in emotion regulation. In this program they will learn how to recognize the emotions they are feeling by assessing their own body language, being attentive to their thought processes, and attempting to replace negative behaviors with positive. Throughout the platform they will engage in written exercises to help them solidify the lessons with their own life experiencing. They will also have the support of peers throughout the program to help them when they need clarification or having a difficult time applying the lesson(s).
| Study group | Role | What they receive |
|---|---|---|
| BPS webSTAIR 6 Levels with Peer Support | Active comparator | Participants in BPS webSTAIR will complete a baseline, posttreatment and 2-month follow-up assessment. In the BPS webSTAIR condition, participants will first complete a welcome module to orient them to the program. After randomization, participants will have 10 weeks to complete the 6 modules. Every time the Veteran logs on they will have the opportunity to engage with a Veteran peer for support through the web program. Contacts can last for up to an hour. Veterans will receive a series of automated reminders and engagement emails that the Vets Prevail program sends at various points in the program. Receives: Other: Brief Peer Supported webSTAIR |
| Wait List | No intervention | In Wait list, participants will be asked to go about their life as usual. They will be asked not to participate in any other programs for PTSD or depression symptoms for 10 weeks. After the 10 weeks, WL participants can begin any other program for PTSD or depression. They will also be given the option of participating in BPS webSTAIR or be provided with information about other web-based programs that might be of interest or relevant to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD and making a provisional PTSD diagnosis. The scale ranges from Not At All (0) to Extremely (4) Higher scores relate to more severe symptoms.
Measured: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Change from Baseline on Personal Health Questionnaire Depression Scale (PHQ - 8) at program completion and at two months after program completion.
The eight-item Personal Health Questionnaire Depression Scale (PHQ - 8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies.The scale ranges from Not At All (1) to Nearly Every Day (4) Higher scores relate to more severe symptoms.
Measured: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Change from Baseline on Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) at program completion and at two months after program completion.
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a widely-used, theoretically-driven, and psychometrically-sound self-report measure of emotion regulation difficulties. The scale ranges from Almost Never (1) to Almost Always (5). Higher scores relate to more severe symptoms.
Measured: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Change from Baseline on The Work and Social Adjustment Scale (WSAS) at program completion and at two months after program completion.
The The Work and Social Adjustment Scale (WSAS) is a measure of people's problems sometimes affect their ability to do certain day-to-day tasks in their lives. To rate your problems, look at each section and determine on the scale provided how much your problem impairs your ability to carry out the activity in the past month.The scale ranges from No Impairment (0) to Very Severe Impairment (8). Higher scores relate to more severe impairment.
Measured: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Life Events Checklist for DSM-5 (LEC-2)
The Life Events Checklist for DSM-5 (LEC-2) lists difficult or stressful things that sometimes happen to people. Mark the item for any single stressful event you have experienced. Be sure to consider your entire life (growing up, as well as adulthood) as you go through the list of events. You do not need to answer any of these questions if doing so would be distressing. The scale consists of Yes, No and Prefer Not To Answer. More Yes responses indicate experiencing more traumatic events in a participant's history.
Measured: Before the participant is randomized to a condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start20 Jan 2020
- Primary completion1 Jun 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marylène Cloitre, Palo Alto Veterans Institute for Research
- Investigators
- Marylene Cloitre, PhD, Principal investigator, National Center for PTSD Dissemination and Training Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286165
- Sponsor's protocol ID
- CLO0009
- Acronym
- BPSwS
- Status last verified
- Aug 2023
- First submitted
- 8 Jan 2020
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ong LE, Speicher S, Villasenor D, Kim J, Jacobs A, Macia KS, Cloitre M. Brief Peer-Supported Web-Based Skills Training in Affective and Interpersonal Regulation (BPS webSTAIR) for Trauma-Exposed Veterans in the Community: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e52130. doi: 10.2196/52130.
PubMed 39012722
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Enhanced Wait List
- ClinicalTrials.gov ID
- NCT04286165
- Acronym / sponsor ID
- BPSwS / CLO0009
- Keywords
- PTSD, Post Traumatic Stress Disorder, Depression, Emotion Regulation, Skills Building, Peer, Coaching, Online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 26 Feb 2020 (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.
This study will enroll 180 Veterans at a 2:1 ratio where 120 Veterans will be enrolled into a brief transdiagnostic peer supported webSTAIR (BPS webSTAIR) and 60 will be supported into Waitlist. The purpose of the study is to assess the efficacy BPS webSTAIR in regard to four outcomes: reduction in PTSD and depression symptoms (measured by the PCL-5 and PHQ-8, respectively) and improvement in emotion regulation and work and social adjustment (measured by the DERS-16 and WSAS, respectively). The active treatment is a 6-session modular treatment that focuses on learning emotion management skills where Particpants will have 10 weeks to complete the treatment. Assessments will occur three times for those in webSTAIR: baseline, post-treatment (10 weeks after randomization) and 8-week follow-up and twice for those on waitlist (baseline and 10 weeks after randomization). It is hypothesized that BPS WebSTAIR will be superior to the Waitlist condition on all four outcomes. Mixed Effects Models will be used to evaluate the outcomes.
Detailed description
The purpose of this randomized controlled trial is to assess the efficacy of a brief version of webSTAIR (BPS webSTAIR) supported by peers compared to a waitlist condition (WL). Brief peer supported (BPS) webSTAIR is a 6-module web-based transdiagnostic program that provides skills training in emotion regulation; participants in this condition will be able to contact a Veteran peer trained in the program to obtain general support plus guidance about program use and application of skills.
An 11-module version of webSTAIR with therapist coaching has provided pilot data that the program is effective in reducing symptoms of posttraumatic stress disorder (PTSD) and depression as well as improving emotion regulation and work and social adjustment. Pilot data indicate that initial gains are made in the first 6 sessions. In addition, qualitative interviews with Veterans who have completed the program indicate high satisfaction with these modules. This study will assess whether a shorter version of the treatment (6 rather than 11 modules) and with peer rather than professional coaching will be effective compared to a waitlist condition. The BPS webSTAIR program was developed with the aim of providing a treatment for trauma-related symptoms that is effective, brief, engaging and likely to be completed by the user. The reduction of the number of modules creates a briefer treatment than the investigators current web-based program. In addition, data indicated that integrating Veteran peers into mental health programs leads to better engagement and greater retention providing the rationale for including Veteran peers rather than therapists (e.g., psychologists, social workers). Given the absence of findings that a brief, peer-supported version of webSTAIR provides improvement in the above symptoms, the research team followed recommendations for the development and testing of psychotherapies and used a waitlist control as an initial test of efficacy.
The aim is to establish the efficacy of BPS webSTAIR in improving symptoms of PTSD and depression, emotion regulation problems and work and social adjustment compared to a Waitlist Control.
Hypothesis 1a: Compared to WL, BPS webSTAIR will provide greater improvement in PTSD symptoms as measured by the PCL5 and depression as measured by the PHQ-8 (secondary outcome). Assessments will be made at pre-treatment, post-treatment, and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks from randomization) for WL.
Hypothesis 1b: Compared to WL, BPS webSTAIR will provide greater improvement in emotion regulation as measured by the DERS-16 and overall functioning as measured by the work and social adjustment scale (WSAS) (secondary outcomes). Assessments will be made at pre-treatment, post-treatment and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks after randomization) for WL.
In the BPS webSTAIR condition, participants will first complete a welcome module to orient them to the program. After randomization, participants will have 10 weeks to complete the 6 modules. Every time the Veteran logs on they will have the opportunity to engage with a Veteran peer for support through the web program. Contacts can last for up to an hour. Veterans will receive a series of automated reminders and engagement emails that the Vets Prevail program sends at various points in the program.
The equivalence of the treatment conditions on baseline variables demographics and psychological variables) will be assessed and controlled (if necessary) in the final analyses. Other preliminary analyses will include examination of distributional properties of the measures. Transformations will be used to improve distributions when necessary. Missing data patterns (from missed assessments and from dropout) will be examined and compared between conditions. Mixed Effects Models (MEMs) will be used to evaluate differences between the two treatments over time with time as a main effect and treatment-by-time as an interaction term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPS webSTAIR 6 Levels with Peer Support | Active comparator | Other: Brief Peer Supported webSTAIRParticipants in BPS webSTAIR will complete a baseline, posttreatment and 2-month follow-up assessment. In the BPS webSTAIR condition, participants will first complete a welcome module to orient them to the program. After randomization, participants will have 10 weeks to complete the 6 modules. Every time the Veteran logs on they will have the opportunity to engage with a Veteran peer for support through the web program. Contacts can last for up to an hour. Veterans will receive a series of automated reminders and engagement emails that the Vets Prevail program sends at various points in the program. |
| Wait List | No intervention | –In Wait list, participants will be asked to go about their life as usual. They will be asked not to participate in any other programs for PTSD or depression symptoms for 10 weeks. After the 10 weeks, WL participants can begin any other program for PTSD or depression. They will also be given the option of participating in BPS webSTAIR or be provided with information about other web-based programs that might be of interest or relevant to them. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read/write English
- Internet connection allowing stable access to VetsPrevail website
- Have experienced at least one traumatic event (positive on the LEC)
- A score greater than or equal to 3 on the PC-PTSD OR greater than or equal to 2 on the PHQ2 on the screen.
- Enrollment into the webSTAIR study must be completed within two weeks of completing screener/eligibility based on symptoms.
Key exclusion criteria (4 listed)
- Currently receiving a trauma-focused intervention (PE, CPT, EMDR, WET) assessed during baseline
- Being unlikely to benefit from therapy or Telemental health, for example:
- Cognitive difficulties as indicated during baseline assessment.
- Active psychosis as indicated during baseline assessment
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 |
|---|---|---|
| Brief Peer Supported webSTAIRThe BPS webSTAIR program is an online platform where individuals are taught skills in emotion regulation. In this program they will learn how to recognize the emotions they are feeling by assessing their own body language, being attentive to their thought processes, and attempting to replace negative behaviors with positive. Throughout the platform they will engage in written exercises to help them solidify the lessons with their own life experiencing. They will also have the support of peers throughout the program to help them when they need clarification or having a difficult time applying the lesson(s). | Other | BPS webSTAIR 6 Levels with Peer Support |
Primary outcome
Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.
Time frame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD and making a provisional PTSD diagnosis. The scale ranges from Not At All (0) to Extremely (4) Higher scores relate to more severe symptoms.
Change from Baseline on Personal Health Questionnaire Depression Scale (PHQ - 8) at program completion and at two months after program completion.
Time frame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The eight-item Personal Health Questionnaire Depression Scale (PHQ - 8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies.The scale ranges from Not At All (1) to Nearly Every Day (4) Higher scores relate to more severe symptoms.
Change from Baseline on Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) at program completion and at two months after program completion.
Time frame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a widely-used, theoretically-driven, and psychometrically-sound self-report measure of emotion regulation difficulties. The scale ranges from Almost Never (1) to Almost Always (5). Higher scores relate to more severe symptoms.
Change from Baseline on The Work and Social Adjustment Scale (WSAS) at program completion and at two months after program completion.
Time frame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The The Work and Social Adjustment Scale (WSAS) is a measure of people's problems sometimes affect their ability to do certain day-to-day tasks in their lives. To rate your problems, look at each section and determine on the scale provided how much your problem impairs your ability to carry out the activity in the past month.The scale ranges from No Impairment (0) to Very Severe Impairment (8). Higher scores relate to more severe impairment.
Life Events Checklist for DSM-5 (LEC-2)
Time frame: Before the participant is randomized to a condition.
The Life Events Checklist for DSM-5 (LEC-2) lists difficult or stressful things that sometimes happen to people. Mark the item for any single stressful event you have experienced. Be sure to consider your entire life (growing up, as well as adulthood) as you go through the list of events. You do not need to answer any of these questions if doing so would be distressing. The scale consists of Yes, No and Prefer Not To Answer. More Yes responses indicate experiencing more traumatic events in a participant's history.
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 18 Aug 2023.
- Derived from this study: PubMed 39012722Ong LE, Speicher S, Villasenor D, Kim J, Jacobs A, Macia KS, Cloitre M. Brief Peer-Supported Web-Based Skills Training in Affective and Interpersonal Regulation (BPS webSTAIR) for Trauma-Exposed Veterans in the Community: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e52130. doi: 10.2196/52130.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylene Cloitre, PhD principal investigator
National Center for PTSD Dissemination and Training Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Peer Supported webSTAIR in people with Post Traumatic Stress Disorder and Depression, run by Palo Alto Veterans Institute for Research 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 5 inclusion and 4 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 18 Aug 2023. 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?
Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion. (time frame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.). The study lists 5 primary outcomes in all. 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 NCT04286165, which also lists 1 linked publication.
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 18 Aug 2023.