Traumatic Brain InjuryNCT04143243
One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
A study testing ACT on Life and Education, Resources, and Support in people with Traumatic Brain Injury and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Chronic Pain, Post Traumatic Stress Disorder
- What is being tested?
- ACT on Life and Education, Resources, and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 3 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- OIF/OEF/OND Veteran
- Stress-based psychopathology, as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD on the M.I.N.I. International Neuropsychiatric interview (M.I.N.I.)
- Deployment-related mild TBI according to the definition of VA/DOD Clinical Practice Guidelines and determined by interview on the Boston Assessment of TBI-Lifetime (BAT-L)
- Pain intensity and level of interference reported to be 5 (moderate) on the Defense and Veterans Pain Rating Scale (DVPRS)
Who cannot join
- History of bipolar disorder or primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) on the M.I.N.I.
- A current diagnosis of severe substance use disorder on the M.I.N.I.
- Moderate to severe suicide risk on the suicidality scale on the M.I.N.I.
- History of neurological illness not related to TBI (self-reported and confirmed by Dr. Jorge)
- Severe medical illness (e.g. liver failure, severe coronary artery disease and /or heart failure) posing a new and significant stress burden and requiring intensive treatment (self-reported and confirmed by Dr. Jorge)
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
About this study
Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.
Read the detailed description
Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Operation Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent exposed to a mild TBI (mTBI) and experiencing persistent post-concussive symptoms. Among those with a mTBI diagnosis, the majority also suffers from stress-based psychopathology (e.g., depression, post-traumatic stress disorder, generalized anxiety disorder), as well as chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face significant barriers to engaging in mental health treatment, including stigma, the belief that one should overcome psychological difficulties on his/her own, and concern that receiving such care would negatively impact their careers. Practical barriers, including time constraints, distance from a treatment facility, and competing priorities (e.g., work and family demands), are also barriers to care. Even among Veterans who start mental health treatment, only a small minority complete a recommended course of evidence-based therapy.
Acceptance and Commitment Therapy (ACT) is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities. In this context, Veterans are asked to think about their "new mission(s)" after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult. ACT has established efficacy in the treatment of depression, anxiety, and chronic pain, and has been effectively implemented in various treatment-delivery formats, including 1-day group workshops. A 1-day ACT workshop addresses specific needs of Veterans with mTBI, stress-based psychopathology, and chronic pain (polytrauma triad) and important barriers to treatment. It 1) is trans-diagnostic (i.e., applies to more than one condition); 2) targets avoidance-based coping; 3) cultivates acceptance-based coping and builds on Veteran's values and goals to motivate them to make difficult decisions; 4) is delivered efficiently and thus more accessible; 5) is less stigmatizing and thus acceptable; and 6) address problems with treatment adherence and completion.
With the support of an RR\&D SPiRE pilot grant, the PIs developed a 1-day 'ACT on Life' workshop tailored specifically for the needs of Veterans with mTBI, stress-based psychopathology, and chronic pain. Veterans with this polytrauma were then randomly assigned to the 'ACT on Life' workshop (N=20) or to Treatment as Usual (TAU; N=12). All Veterans attending the 1-day ACT workshop completed it, and relative to TAU, exhibited greater improvements in distress and reintegration at the 3-month follow-up (effect sizes .68 and .47, respectively). Building on these promising preliminary findings, the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison (Education, Resources, and Support; ERS) on symptoms of distress and social, occupational, and community reintegration. The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors.
Establishing the efficacy of a 1-day ACT workshop for OEF/OEF/OND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RR\&D: 1. developing interventions which will improve the psychological health status of Veterans who have specific needs; and 2. enhancing the community, social, and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society.
- Being tested
- ACT on Life, Education, Resources, and Support
- Keywords
- Acceptance and Commitment Therapy, Veterans, polytrauma, traumatic brain injury, chronic pain, Post Traumatic Stress Disorder, depression, Anxiety
- Medical subject headings
- Brain Injuries, Traumatic, Chronic Pain, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT on LifeBehavioural
Also called ACT plus ERS
1 day group workshop of ACT plus ERS
Education, Resources, and SupportBehavioural
Also called ERS
1 day group workshop of Education, Resources, and Support
| Study group | Role | What they receive |
|---|---|---|
| ACT on Life | Active comparator | Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour). Receives: Behavioral: ACT on Life |
| Education, Resources, and Support | Placebo comparator | Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered Receives: Behavioral: Education, Resources, and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score
The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.
Measured: Through study completion, an average of 6 months following workshop/intervention attendance.
Military to Civilian Questionnaire (M2C-Q)
The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked "Does not apply").The Minimum possible score is 0 (if all items are answered as "no difficulty" or "does not apply"). Maximum possible score is 4 (if all items are answered as "extreme difficulty"). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.
Measured: Through study completion, an average of 6 months following workshop/intervention attendance.
Secondary outcomes (2)
The PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire to assess post-traumatic stress disorder (PTSD) based on criteria of the Diagnostic and Statistical Manual for Mental Disorders - Version 5 (DSM-5). This scale is available from the National Center for PTSD and is extensively used in Veteran populations. Each item is rated on a 5-point scale with anchors from "not at all" to "extremely" indicating how much the participant has been bothered by the PTSD symptoms in the past month. A total symptom severity score can be obtained by summing the scores for a range of scores from 0 to 80. A higher total score demonstrates more severe PTSD symptoms.
Measured: Through study completion, an average of 6 months following workshop/intervention attendance.
Defense and Veterans Pain Rating Scale (Pain Severity)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool that assesses severity of pain. It uses a numerical scale ranging from 0 to 10 to assess pain intensity. Minimum Score: 0, representing "No pain". Maximum Score: 10, representing "As bad as pain can be, nothing else matters". It is a reliable and valid instrument developed for use in military populations.
Measured: Through study completion, an average of 6 months following workshop/intervention attendance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jul 2020
- Primary completion3 Aug 2024
- Study completion3 Aug 2024
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 Traumatic Brain InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ACT plus Education, Resources and Support ('ACT on Life') workshop compared to Education, Resources, \& Support only workshop (ERS)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lilian N. Dindo, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143243
- Sponsor's protocol ID
- D3117-R
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2019
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
- ClinicalTrials.gov ID
- NCT04143243
- Acronym / sponsor ID
- D3117-R
- Keywords
- Acceptance and Commitment Therapy, Veterans, polytrauma, traumatic brain injury, chronic pain, Post Traumatic Stress Disorder, depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.
Detailed description
Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Operation Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent exposed to a mild TBI (mTBI) and experiencing persistent post-concussive symptoms. Among those with a mTBI diagnosis, the majority also suffers from stress-based psychopathology (e.g., depression, post-traumatic stress disorder, generalized anxiety disorder), as well as chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face significant barriers to engaging in mental health treatment, including stigma, the belief that one should overcome psychological difficulties on his/her own, and concern that receiving such care would negatively impact their careers. Practical barriers, including time constraints, distance from a treatment facility, and competing priorities (e.g., work and family demands), are also barriers to care. Even among Veterans who start mental health treatment, only a small minority complete a recommended course of evidence-based therapy.
Acceptance and Commitment Therapy (ACT) is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities. In this context, Veterans are asked to think about their "new mission(s)" after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult. ACT has established efficacy in the treatment of depression, anxiety, and chronic pain, and has been effectively implemented in various treatment-delivery formats, including 1-day group workshops. A 1-day ACT workshop addresses specific needs of Veterans with mTBI, stress-based psychopathology, and chronic pain (polytrauma triad) and important barriers to treatment. It 1) is trans-diagnostic (i.e., applies to more than one condition); 2) targets avoidance-based coping; 3) cultivates acceptance-based coping and builds on Veteran's values and goals to motivate them to make difficult decisions; 4) is delivered efficiently and thus more accessible; 5) is less stigmatizing and thus acceptable; and 6) address problems with treatment adherence and completion.
With the support of an RR\&D SPiRE pilot grant, the PIs developed a 1-day 'ACT on Life' workshop tailored specifically for the needs of Veterans with mTBI, stress-based psychopathology, and chronic pain. Veterans with this polytrauma were then randomly assigned to the 'ACT on Life' workshop (N=20) or to Treatment as Usual (TAU; N=12). All Veterans attending the 1-day ACT workshop completed it, and relative to TAU, exhibited greater improvements in distress and reintegration at the 3-month follow-up (effect sizes .68 and .47, respectively). Building on these promising preliminary findings, the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison (Education, Resources, and Support; ERS) on symptoms of distress and social, occupational, and community reintegration. The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors.
Establishing the efficacy of a 1-day ACT workshop for OEF/OEF/OND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RR\&D: 1. developing interventions which will improve the psychological health status of Veterans who have specific needs; and 2. enhancing the community, social, and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- ACT plus Education, Resources and Support ('ACT on Life') workshop compared to Education, Resources, \& Support only workshop (ERS)
| Arm | Type | Receives |
|---|---|---|
| ACT on Life | Active comparator | Behavioral: ACT on LifeAcceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life'). The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour). |
| Education, Resources, and Support | Placebo comparator | Behavioral: Education, Resources, and SupportInformation provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OIF/OEF/OND Veteran
- Stress-based psychopathology, as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD on the M.I.N.I. International Neuropsychiatric interview (M.I.N.I.)
- Deployment-related mild TBI according to the definition of VA/DOD Clinical Practice Guidelines and determined by interview on the Boston Assessment of TBI-Lifetime (BAT-L)
- Pain intensity and level of interference reported to be 5 (moderate) on the Defense and Veterans Pain Rating Scale (DVPRS)
Key exclusion criteria (5 listed)
- History of bipolar disorder or primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) on the M.I.N.I.
- A current diagnosis of severe substance use disorder on the M.I.N.I.
- Moderate to severe suicide risk on the suicidality scale on the M.I.N.I.
- History of neurological illness not related to TBI (self-reported and confirmed by Dr. Jorge)
- Severe medical illness (e.g. liver failure, severe coronary artery disease and /or heart failure) posing a new and significant stress burden and requiring intensive treatment (self-reported and confirmed by Dr. Jorge)
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 |
|---|---|---|
| ACT on LifeAlso: ACT plus ERS1 day group workshop of ACT plus ERS | Behavioural | ACT on Life |
| Education, Resources, and SupportAlso: ERS1 day group workshop of Education, Resources, and Support | Behavioural | Education, Resources, and Support |
Primary outcome
The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score
Time frame: Through study completion, an average of 6 months following workshop/intervention attendance.
The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.
Military to Civilian Questionnaire (M2C-Q)
Time frame: Through study completion, an average of 6 months following workshop/intervention attendance.
The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked "Does not apply").The Minimum possible score is 0 (if all items are answered as "no difficulty" or "does not apply"). Maximum possible score is 4 (if all items are answered as "extreme difficulty"). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.
2 secondary outcomes
The PTSD Checklist for DSM-5 (PCL-5)
Time frame: Through study completion, an average of 6 months following workshop/intervention attendance.
Defense and Veterans Pain Rating Scale (Pain Severity)
Time frame: Through study completion, an average of 6 months following workshop/intervention attendance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lilian N. Dindo, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT on Life and Education, Resources, and Support in people with Traumatic Brain Injury and Chronic Pain, run by VA Office of Research and Development 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 4 inclusion and 5 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 8 Oct 2025. 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. Some participants in this study may receive a placebo. 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 8 Oct 2025). 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?
The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score (time frame: Through study completion, an average of 6 months following workshop/intervention attendance.). The study lists 2 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 8 Oct 2025.