Alcohol UseNCT06648395
CBT vs. Supportive Texts for PTSD & Hazardous Drinking (Project Better Study 2)
A study testing CBT Text Messages and Supportive Messages in people with Alcohol Use and Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.
Trial summary
The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Posttraumatic Stress Disorder
- What is being tested?
- CBT Text Messages and Supportive Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to 4 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Currently resides in WA State
- Fluent in English
- Reports at least one DSM-5 traumatic event that occurred 1+ months ago
- Current PTSD severity of 33+ on the PCL-5
- Current hazardous alcohol use (2+ heavy episodic drinking occasions [4+ drinks on one occasion for women, 5+ drinks on one occasion for men] in past month, 1+ negative consequences related to alcohol use)
Show all 9Show fewer
- Owns a functioning cellular phone
- Is willing to receive weekly study text messages for 4 consecutive weeks
- Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)
Who cannot join
- Previous participation in Project BETTER study 1 (NCT05372042)
- Participation in Project COPE+ (IRB# STUDY00022875) (a small-scaled text-based message study that aims to increase positive mood and wellbeing for adults with posttraumatic stress symptoms and hazardous drinking)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 2: Testing the Efficacy of a CBT-enhanced Text Message Intervention to Reduce Symptom Burden in Individuals With Post-traumatic Stress Disorder Symptoms and Co-occurring Hazardous Drinking
The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking.
Read the detailed description
This study will test a previously piloted and refined text message intervention by comparing a CBT text message intervention to supportive messages condition for reducing hazardous drinking (HD) and PTSD symptoms. The intervention will be tested in a fully powered two-arm randomized controlled trial (RCT) comparing a text message intervention (3 texts/week based on CBT skills) to supportive texts. A sample of 333 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, post-, 1-, 3-, 6-, 9-, and 12-month assessments will capture change in primary outcomes (PTSD, hazardous drinking) long-term. Weekly assessments will be given to both conditions to understand shorter-term patterns of symptom change associated with the interventions.
Eligible participants will be individually randomized by the Study Research Coordinator to one of the two conditions. For those in the intervention condition, participants will receive three text messages presenting a CBT skill followed by framing and growth mindsets (sent on Tuesday, Wednesday, Friday). They will also be asked to complete weekly self-reports on PTSD and HD every Monday following their first week of text messages. The supportive messages only group will be sent three short supportive messages, timed to correspond with the CBT skill group, and will be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
Primary measures include measures assessing inclusion criteria and main outcomes. Primary measures are given at screening/baseline and all follow-ups unless otherwise noted.
Demographics including age, race/ethnicity, gender, income/work status, weight (for BAC calculation for safety monitoring), verification of cell phone ownership and willingness to receive messages, certification of English fluency, and current residential zipcode (to verify WA State residency) will be assessed at screening only.
Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC).
HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).
Secondary measures include those assessing secondary outcomes. Unless otherwise noted, secondary measures are given at baseline and 3-, 6-, 9-, and 12-month follow-ups. They include the Alcohol Use Disorders Identification Test (AUDIT), the Depression Anxiety Stress Scales (DASS-21), the Customary Drinking and Drug Use Record (CDDR), the Drug Abuse Screening Test (DAST-10) and the Treatment Services Received (TSR).
Analyses will compare conditions to test effect sizes between the two conditions (text message intervention vs supportive messages). The sample size was selected based on power calculations for detecting a small effect between conditions and also to allow for testing of a-priori chosen effect modifiers (race, gender, trauma type, CBT skill use).
- Conditions
- Alcohol Use, Posttraumatic Stress Disorder
- Being tested
- CBT Text Messages, Supportive Messages
- Keywords
- Alcohol Use, Posttraumatic Stress Disorder, text messages
- Medical subject headings
- Alcohol Drinking, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT Text MessagesBehavioural
CBT text messages will be sent 3 times per week for 4 weeks
Supportive MessagesBehavioural
Supportive text messages will be sent 3 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CBT text messages | Active comparator | Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about a CBT skill, day 2 will be a remainder to use the skill that is framed toward preventing future losses from trauma exposure, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. They will also be asked to complete weekly self-reports on PTSD and HD every Monday for four consecutive weeks. Receives: Behavioral: CBT Text Messages |
| Supportive Text Messages | Active comparator | Participants will be sent three short supportive messages each week that include messages of support, validation, and hope. They will also be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks. Receives: Behavioral: Supportive Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)
The Posttraumatic Stress Disorder Checklist for the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders (PCL-5) assesses the severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the 5th Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is administered at screening through 12 month follow up. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.
Measured: screening through 12 month follow-up
Heavy Episodic Drinking (HED)
Heavy Episodic Drinking (HED) assesses the quantity of heavy drinking episodes (i.e., >4/5 drinks per occasion for women/men, based on the National Institute of Alcohol Abuse and Alcoholism's definition) over the last month. It is administered at screening through 12 month follow up. The range of the scale is 0-10 (count of the number of heavy drinking episodes in the last month); 10 is described as 10 or more heavy drinking episodes. Higher scores represent a greater number of heavy drinking episodes.
Measured: screening through 12 month follow up
Daily Drinking Questionnaire (DDQ)
The Daily Drinking Questionnaire (DDQ) assesses the number of standard drinks consumed each day of a typical week over the last month and is administered at screening through 12 month follow up. The range for the scale to report drinks consumed each day is 0-25. Each day's score for the week is summed to created a total number of drinks consumed per week; the count of drinks consumed per week ranges from 0 to 175. Higher scores representing greater number of drinks consumed during a typical week.
Measured: screening through 12 month follow-up
Short Index of Problems (SIP)
The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at screening through 12 month follow up. The range for the scale is 0-15. Higher scores represent a greater number of alcohol-related consequences.
Measured: screening through 12 month follow-up
Secondary outcomes (5)
Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test (AUDIT) assesses problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months and is administered at pre-intervention (screening) and 12 month follow up. The total range of scores is 0-40. Higher scores represent greater risks of having an alcohol use disorder.
Measured: screening, 12 month follow-up
Depression Anxiety Stress Scales (DASS-21)
The Depression Anxiety Stress Scale (DASS-21) assesses the general psychopathology symptoms over the last month and is administered at pre-intervention (baseline) through 12 month follow up. It has 3 subscales; two of which (anxiety and depression subscales) are outcomes for this study. The total range of scores of the anxiety subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms. The total range of scores of the depression subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms.
Measured: baseline through 12 month follow-up
Customary Drinking and Drug Use Record (CDDR)
The Customary Drinking and Drug Use Record (CDDR) assesses comprehensive substance use, other than alcohol, over the last 3 months and is administered at pre-intervention (baseline) and 12 month follow up. The total range of scores is 0-12 and higher scores indicate more drug use.
Measured: baseline, 12 month follow-up
Drug Abuse Screening Test (DAST-10)
The Drug Abuse Screening Test (DAST-10) assesses the problems related to other substance use and likely drug use disorder diagnosis over the last 12 months and is administered at pre-intervention (baseline) and 12 month follow up. The total range of scores is 0-10 and higher scores indicate more substance use-related problems and likely drug use disorder diagnosis.
Measured: baseline, 12 month follow-up
Treatment Services Received (TSR)
The Treatment Services Received (TSR) assesses the types of mental health and addictions treatments that individuals (e.g., inpatient, outpatient, 12-step, etc) received since enrolling in the study and is administered at pre-intervention (baseline) and 12 month follow up. Twelve types of treatment are listed and counted to calculate the number of types of treatment that individuals received over the study period. The minimum possible score is 0 (no services received) and the maximum is 12 types of treatment. Higher numbers indicate receiving more types of treatment.
Measured: baseline and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Oct 2024
- Primary completion4 Oct 2026
- Study completion4 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michele Bedard-Gilligan, University of Washington
- Investigators
- Kristen Lindgren, PhD, ABPP, Principal investigator, University of WashingtonMichele Bedard-Gilligan, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648395
- Sponsor's protocol ID
- STUDY00020173
- Other IDs
- R01AA028776-01A1
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bedard-Gilligan M, Lindgren K, Dworkin E, Tristao T, Kaysen D, Rhew I. A randomized controlled trial testing theory-driven enhancements to increase the efficacy of and engagement in a brief cognitive-behavioural therapy text-message intervention for co-occurring posttraumatic stress disorder symptoms and alcohol misuse. Br J Clin Psychol. 2025 Mar;64(1):110-124. doi: 10.1111/bjc.12463. Epub 2024 Mar 26.
PubMed 38532251Bedard-Gilligan MA, Dworkin ER, Kaysen D, Ojalehto HJ, Stappenbeck CA, Lindgren KP. A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. J Anxiety Disord. 2022 Oct;91:102615. doi: 10.1016/j.janxdis.2022.102615. Epub 2022 Aug 6.
PubMed 35988440
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 2: Testing the Efficacy of a CBT-enhanced Text Message Intervention to Reduce Symptom Burden in Individuals With Post-traumatic Stress Disorder Symptoms and Co-occurring Hazardous Drinking
- ClinicalTrials.gov ID
- NCT06648395
- Acronym / sponsor ID
- STUDY00020173
- Conditions
- Alcohol Use, Posttraumatic Stress Disorder
- Keywords
- Alcohol Use, Posttraumatic Stress Disorder, text messages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 4 Oct 2026 (actual)
- Study completion
- 4 Oct 2026 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking.
Detailed description
This study will test a previously piloted and refined text message intervention by comparing a CBT text message intervention to supportive messages condition for reducing hazardous drinking (HD) and PTSD symptoms. The intervention will be tested in a fully powered two-arm randomized controlled trial (RCT) comparing a text message intervention (3 texts/week based on CBT skills) to supportive texts. A sample of 333 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, post-, 1-, 3-, 6-, 9-, and 12-month assessments will capture change in primary outcomes (PTSD, hazardous drinking) long-term. Weekly assessments will be given to both conditions to understand shorter-term patterns of symptom change associated with the interventions.
Eligible participants will be individually randomized by the Study Research Coordinator to one of the two conditions. For those in the intervention condition, participants will receive three text messages presenting a CBT skill followed by framing and growth mindsets (sent on Tuesday, Wednesday, Friday). They will also be asked to complete weekly self-reports on PTSD and HD every Monday following their first week of text messages. The supportive messages only group will be sent three short supportive messages, timed to correspond with the CBT skill group, and will be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
Primary measures include measures assessing inclusion criteria and main outcomes. Primary measures are given at screening/baseline and all follow-ups unless otherwise noted.
Demographics including age, race/ethnicity, gender, income/work status, weight (for BAC calculation for safety monitoring), verification of cell phone ownership and willingness to receive messages, certification of English fluency, and current residential zipcode (to verify WA State residency) will be assessed at screening only.
Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC).
HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).
Secondary measures include those assessing secondary outcomes. Unless otherwise noted, secondary measures are given at baseline and 3-, 6-, 9-, and 12-month follow-ups. They include the Alcohol Use Disorders Identification Test (AUDIT), the Depression Anxiety Stress Scales (DASS-21), the Customary Drinking and Drug Use Record (CDDR), the Drug Abuse Screening Test (DAST-10) and the Treatment Services Received (TSR).
Analyses will compare conditions to test effect sizes between the two conditions (text message intervention vs supportive messages). The sample size was selected based on power calculations for detecting a small effect between conditions and also to allow for testing of a-priori chosen effect modifiers (race, gender, trauma type, CBT skill use).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT text messages | Active comparator | Behavioral: CBT Text MessagesParticipants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about a CBT skill, day 2 will be a remainder to use the skill that is framed toward preventing future losses from trauma exposure, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. They will also be asked to complete weekly self-reports on PTSD and HD every Monday for four consecutive weeks. |
| Supportive Text Messages | Active comparator | Behavioral: Supportive MessagesParticipants will be sent three short supportive messages each week that include messages of support, validation, and hope. They will also be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18+ years of age
- Currently resides in WA State
- Fluent in English
- Reports at least one DSM-5 traumatic event that occurred 1+ months ago
- Current PTSD severity of 33+ on the PCL-5
Key exclusion criteria (2 listed)
- Previous participation in Project BETTER study 1 (NCT05372042)
- Participation in Project COPE+ (IRB# STUDY00022875) (a small-scaled text-based message study that aims to increase positive mood and wellbeing for adults with posttraumatic stress symptoms and hazardous drinking)
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 |
|---|---|---|
| CBT Text MessagesCBT text messages will be sent 3 times per week for 4 weeks | Behavioural | CBT text messages |
| Supportive MessagesSupportive text messages will be sent 3 times per week for 4 weeks | Behavioural | Supportive Text Messages |
Primary outcome
Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)
Time frame: screening through 12 month follow-up
The Posttraumatic Stress Disorder Checklist for the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders (PCL-5) assesses the severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the 5th Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is administered at screening through 12 month follow up. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.
Heavy Episodic Drinking (HED)
Time frame: screening through 12 month follow up
Heavy Episodic Drinking (HED) assesses the quantity of heavy drinking episodes (i.e., >4/5 drinks per occasion for women/men, based on the National Institute of Alcohol Abuse and Alcoholism's definition) over the last month. It is administered at screening through 12 month follow up. The range of the scale is 0-10 (count of the number of heavy drinking episodes in the last month); 10 is described as 10 or more heavy drinking episodes. Higher scores represent a greater number of heavy drinking episodes.
Daily Drinking Questionnaire (DDQ)
Time frame: screening through 12 month follow-up
The Daily Drinking Questionnaire (DDQ) assesses the number of standard drinks consumed each day of a typical week over the last month and is administered at screening through 12 month follow up. The range for the scale to report drinks consumed each day is 0-25. Each day's score for the week is summed to created a total number of drinks consumed per week; the count of drinks consumed per week ranges from 0 to 175. Higher scores representing greater number of drinks consumed during a typical week.
Short Index of Problems (SIP)
Time frame: screening through 12 month follow-up
The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at screening through 12 month follow up. The range for the scale is 0-15. Higher scores represent a greater number of alcohol-related consequences.
5 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: screening, 12 month follow-up
Depression Anxiety Stress Scales (DASS-21)
Time frame: baseline through 12 month follow-up
Customary Drinking and Drug Use Record (CDDR)
Time frame: baseline, 12 month follow-up
Drug Abuse Screening Test (DAST-10)
Time frame: baseline, 12 month follow-up
Treatment Services Received (TSR)
Time frame: baseline and 12 month follow-up
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 29 Oct 2026.
- Background: PubMed 38532251Bedard-Gilligan M, Lindgren K, Dworkin E, Tristao T, Kaysen D, Rhew I. A randomized controlled trial testing theory-driven enhancements to increase the efficacy of and engagement in a brief cognitive-behavioural therapy text-message intervention for co-occurring posttraumatic stress disorder symptoms and alcohol misuse. Br J Clin Psychol. 2025 Mar;64(1):110-124. doi: 10.1111/bjc.12463. Epub 2024 Mar 26.
- Background: PubMed 35988440Bedard-Gilligan MA, Dworkin ER, Kaysen D, Ojalehto HJ, Stappenbeck CA, Lindgren KP. A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. J Anxiety Disord. 2022 Oct;91:102615. doi: 10.1016/j.janxdis.2022.102615. Epub 2022 Aug 6.
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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.
Kristen Lindgren, PhD, ABPP principal investigator
University of Washington
Michele Bedard-Gilligan, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT Text Messages and Supportive Messages in people with Alcohol Use and Posttraumatic Stress Disorder, run by University of Washington 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 9 inclusion and 2 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5) (time frame: screening through 12 month follow-up). The study lists 4 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 NCT06648395, which also lists 2 linked publications.
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 29 Oct 2026.