Non-suicidal Self-injury (NSSI)ASISTNCT07910110
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
A study testing Adolescent Self-Injury Intervention Skills Training (ASIST) and Treatment as Usual (TAU) in people with Non-suicidal Self-injury (NSSI) and Adolescent, run by Seoul National University at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of Adolescent Self-Injury Intervention Skills Training (ASIST), a treatment program developed by the research team, compared with treatment as usual (TAU) in adolescents who engage in non-suicidal self-injury (NSSI). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Non-suicidal Self-injury (NSSI), Adolescent
- What is being tested?
- Adolescent Self-Injury Intervention Skills Training (ASIST) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents aged 12 to 17 years.
- Adolescents who meet the DSM-5 diagnostic criteria for non-suicidal self-injury (NSSI) and report at least one episode of self-injurious behavior within the past month.
- Adolescents who report at least one episode of self-injurious behavior within the past year, as assessed by the Self-Harm Inventory (SHI).
- Participants currently taking psychiatric medication must have maintained a stable dosage for at least one month prior to enrollment.
Who cannot join
- History of psychotic disorders, including schizophrenia, or bipolar disorder.
- History of eating disorders.
- Presence of developmental disorders, including autism spectrum disorder.
- History of alcohol or substance abuse within the past six months.
- Presence of coexisting medical or neurological conditions.
- Changes in psychiatric medication dosage within one month prior to enrollment.
- History of an actual suicide attempt within the past year, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae-Won Kim, MD, PhD, 82-2-2072-3648, kimjw412@snu.ac.kr
About this study
The goal of this clinical trial is to evaluate the effectiveness and safety of Adolescent Self-Injury Intervention Skills Training (ASIST), a treatment program developed by the research team, compared with treatment as usual (TAU) in adolescents who engage in non-suicidal self-injury (NSSI).
The main questions it aims to answer are:
Read more
- How do the effectiveness and safety of ASIST compare with those of treatment as usual in adolescents with NSSI?
- How are treatment-related changes in psychological, clinical, behavioral, and biological measures associated with treatment response?
- Can machine learning techniques be used to predict treatment responses in adolescents with NSSI?
Researchers will compare adolescents receiving ASIST with those receiving TAU to examine changes in psychological, clinical, and behavioral characteristics before and after treatment. They will also examine changes in cortisol and beta-endorphin levels, as well as brain activity and functional connectivity during task performance, to explore potential mechanisms associated with treatment response.
Participants will:
- Receive either ASIST or TAU.
- Complete psychological, clinical, and behavioral assessments before and after treatment.
- Undergo measurements of cortisol and beta-endorphin levels.
- Complete tasks during brain imaging assessments to measure brain activity and functional connectivity.
- Conditions
- Non-suicidal Self-injury (NSSI), Adolescent
- Being tested
- Adolescent Self-Injury Intervention Skills Training (ASIST), Treatment as Usual (TAU)
- Keywords
- Non-Suicidal Self-Injury (NSSI), Adolescent, Adolescent Self-Injury Intervention Skills Training, Psychological Intervention, Treatment Response, Neurobiological Mechanisms, Functional Brain Connectivity, Machine Learning
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Self-Injury Intervention Skills Training (ASIST)Behavioural
ASIST is a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks, focusing on: (1) understanding self-injury, behavioral chain analysis, and safety planning; (2) identifying and modifying automatic thoughts, core beliefs, and rumination; (3) improving emotional awareness, expression, and regulation; and (4) developing stress management, coping, and interpersonal communication skills. The intervention incorporates cognitive behavioral and emotion regulation strategies. Participants with persistent clinically significant difficulties at the four-week follow-up may receive two additional sessions addressing cognitive and interpretation biases and difficulties identifying and expressing emotions.
Treatment as Usual (TAU)Behavioural
Participants assigned to the TAU group will receive routine clinical care for non-suicidal self-injurious behavior over a 4-week period. Depending on their individual clinical needs, treatment may include psychoeducation, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy, consistent with usual care practices in child and adolescent psychiatry.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Self-Injury Intervention Skills Training (ASIST) | Experimental | Participants assigned to this arm will receive Adolescent Self-Injury Intervention Skills Training (ASIST), a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks and incorporates cognitive behavioral therapy, emotion regulation, stress coping skills, and interpersonal skills training. The sessions focus on understanding self-injury and developing safety plans, identifying and modifying negative automatic thoughts, improving emotional awareness and regulation, and developing adaptive stress coping strategies. Participants who continue to demonstrate clinically significant difficulties at the four-week follow-up assessment may receive two additional advanced sessions targeting cognitive biases and difficulties identifying and expressing emotions. Receives: Behavioral: Adolescent Self-Injury Intervention Skills Training (ASIST) |
| Treatment as Usual (TAU) | Active comparator | Participants assigned to this arm will receive treatment as usual (TAU) for non-suicidal self-injury over four weeks. Treatment will consist of routine clinical interventions typically provided to adolescents presenting with self-injurious behaviors in child and adolescent psychiatric settings, including psychoeducation on self-injury prevention, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy. Participants will undergo the same baseline, post-treatment, and four-week follow-up assessments as those in the ASIST group. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Harming Behaviors as Assessed by the Self-Harm Inventory (SHI)
Self-harming behaviors will be assessed using the Korean version of the Self-Harm Inventory (SHI), a 20-item self-report questionnaire evaluating the frequency of self-harming and self-destructive behaviors. Participants rate each item based on their experiences over the past 4 weeks or their current experiences, using a 4-point Likert scale ranging from 1 (almost never) to 4 (always). Total scores range from 20 to 80, with higher scores indicating more frequent or severe self-harming behaviors. Changes in total SHI scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Secondary outcomes (6)
Change in Frequency of Non-Suicidal Self-Injury as Assessed by the Korean Inventory of Statements About Self-Injury (K-ISAS)
The functions of non-suicidal self-injury (NSSI) will be assessed using the K-ISAS, a self-report questionnaire evaluating NSSI behaviors and their underlying functions. The assessment of NSSI functions consists of 39 items measuring 13 functions of NSSI, categorized into intrapersonal and interpersonal functions. Each item is rated on a 3-point Likert scale ranging from 0 (not relevant) to 2 (very relevant), yielding a total score ranging from 0 to 78. Higher scores indicate greater endorsement of NSSI functions. Changes in total scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Severity of Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation severity will be assessed using the C-SSRS, assessing suicidal ideation and behavior. Suicidal ideation severity is evaluated using five yes/no items and scored on a scale from 0 (no suicidal ideation) to 5 (active suicidal ideation with a specific plan and intent). Higher scores indicate greater severity of suicidal ideation. A suicidal ideation severity score of 4 or higher will be used as the cutoff for elevated suicide risk in this study. Changes in suicidal ideation severity scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Emotion Regulation Difficulties as Assessed by the Difficulties in Emotion Regulation Scale-16 (DERS-16)
DERS-16 is a 16-item self-report questionnaire designed to assess difficulties in emotion regulation across five domains: nonacceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to emotion regulation strategies, and lack of emotional clarity. Each item is rated on a 5-point Likert scale ranging from 0 (almost never) to 5 (almost always), yielding a total score ranging from 16 to 80. Higher scores indicate greater difficulties in emotion regulation. Changes in total DERS-16 scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Impulsivity as Assessed by the Barratt Impulsiveness Scale-Brief (BIS-Brief)
The BIS-Brief is an 8-item self-report questionnaire designed to assess impulsivity as a unidimensional construct. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (almost always), yielding a total score ranging from 0 to 24. Higher scores indicate greater impulsivity. Changes in total BIS-Brief scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Depressive Symptom Severity as Assessed by the Children's Depression Rating Scale-Revised (CDRS-R)
The CDRS-R is a 17-item clinician-rated scale to measure the severity of depression of children and adolescents. The scale evaluates emotional, cognitive, behavioral, and somatic symptoms associated with depression. Depression symptoms are rated on a 5-point scale from 1 to 5 for sleep, appetite, and tempo of speech items and a 7-point scale from 1 to 7 for remaining 14 items. Total scores range from 17 (normal) to 113 (severe depression), with higher scores indicating greater severity of depressive symptoms. Changes in total CDRS-R scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Anxiety Symptoms as Assessed by the Screen for Child Anxiety Related Emotional Disorders (SCARED)
The SCARED is a 41-item questionnaire designed to assess anxiety symptoms in children and adolescents across five domains: panic/somatic symptoms, generalized anxiety, separation anxiety, social anxiety, and school avoidance. Each item is rated on a 3-point Likert scale ranging from 0 (not true or hardly ever true) to 2 (very true or often true), yielding a total score ranging from 0 to 82. Higher scores indicate greater severity of anxiety symptoms. A total score of 25 or higher suggests the possible presence of an anxiety disorder, while a score of 30 or higher indicates increased likelihood of an anxiety disorder. Changes in total SCARED scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
Measured: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injury (NSSI)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Jae-Won Kim, Seoul National University
- Investigators
- Jae-Won Kim, MD, PhD, Principal investigator, Seoul National University and Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910110
- Sponsor's protocol ID
- 17-2021-0045
- Acronym
- ASIST
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
- ClinicalTrials.gov ID
- NCT07910110
- Acronym / sponsor ID
- ASIST / 17-2021-0045
- Conditions
- Non-suicidal Self-injury (NSSI), Adolescent
- Keywords
- Non-Suicidal Self-Injury (NSSI), Adolescent, Adolescent Self-Injury Intervention Skills Training, Psychological Intervention, Treatment Response, Neurobiological Mechanisms, Functional Brain Connectivity, Machine Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (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 goal of this clinical trial is to evaluate the effectiveness and safety of Adolescent Self-Injury Intervention Skills Training (ASIST), a treatment program developed by the research team, compared with treatment as usual (TAU) in adolescents who engage in non-suicidal self-injury (NSSI).
The main questions it aims to answer are:
- How do the effectiveness and safety of ASIST compare with those of treatment as usual in adolescents with NSSI?
- How are treatment-related changes in psychological, clinical, behavioral, and biological measures associated with treatment response?
- Can machine learning techniques be used to predict treatment responses in adolescents with NSSI?
Researchers will compare adolescents receiving ASIST with those receiving TAU to examine changes in psychological, clinical, and behavioral characteristics before and after treatment. They will also examine changes in cortisol and beta-endorphin levels, as well as brain activity and functional connectivity during task performance, to explore potential mechanisms associated with treatment response.
Participants will:
- Receive either ASIST or TAU.
- Complete psychological, clinical, and behavioral assessments before and after treatment.
- Undergo measurements of cortisol and beta-endorphin levels.
- Complete tasks during brain imaging assessments to measure brain activity and functional connectivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent Self-Injury Intervention Skills Training (ASIST) | Experimental | Behavioral: Adolescent Self-Injury Intervention Skills Training (ASIST)Participants assigned to this arm will receive Adolescent Self-Injury Intervention Skills Training (ASIST), a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks and incorporates cognitive behavioral therapy, emotion regulation, stress coping skills, and interpersonal skills training. The sessions focus on understanding self-injury and developing safety plans, identifying and modifying negative automatic thoughts, improving emotional awareness and regulation, and developing adaptive stress coping strategies. Participants who continue to demonstrate clinically significant difficulties at the four-week follow-up assessment may receive two additional advanced sessions targeting cognitive biases and difficulties identifying and expressing emotions. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Participants assigned to this arm will receive treatment as usual (TAU) for non-suicidal self-injury over four weeks. Treatment will consist of routine clinical interventions typically provided to adolescents presenting with self-injurious behaviors in child and adolescent psychiatric settings, including psychoeducation on self-injury prevention, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy. Participants will undergo the same baseline, post-treatment, and four-week follow-up assessments as those in the ASIST group. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents aged 12 to 17 years.
- Adolescents who meet the DSM-5 diagnostic criteria for non-suicidal self-injury (NSSI) and report at least one episode of self-injurious behavior within the past month.
- Adolescents who report at least one episode of self-injurious behavior within the past year, as assessed by the Self-Harm Inventory (SHI).
- Participants currently taking psychiatric medication must have maintained a stable dosage for at least one month prior to enrollment.
Key exclusion criteria (7 listed)
- History of psychotic disorders, including schizophrenia, or bipolar disorder.
- History of eating disorders.
- Presence of developmental disorders, including autism spectrum disorder.
- History of alcohol or substance abuse within the past six months.
- Presence of coexisting medical or neurological conditions.
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 |
|---|---|---|
| Adolescent Self-Injury Intervention Skills Training (ASIST)ASIST is a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks, focusing on: (1) understanding self-injury, behavioral chain analysis, and safety planning; (2) identifying and modifying automatic thoughts, core beliefs, and rumination; (3) improving emotional awareness, expression, and regulation; and (4) developing stress management, coping, and interpersonal communication skills. The intervention incorporates cognitive behavioral and emotion regulation strategies. Participants with persistent clinically significant difficulties at the four-week follow-up may receive two additional sessions addressing cognitive and interpretation biases and difficulties identifying and expressing emotions. | Behavioural | Adolescent Self-Injury Intervention Skills Training (ASIST) |
| Treatment as Usual (TAU)Participants assigned to the TAU group will receive routine clinical care for non-suicidal self-injurious behavior over a 4-week period. Depending on their individual clinical needs, treatment may include psychoeducation, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy, consistent with usual care practices in child and adolescent psychiatry. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in Self-Harming Behaviors as Assessed by the Self-Harm Inventory (SHI)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Self-harming behaviors will be assessed using the Korean version of the Self-Harm Inventory (SHI), a 20-item self-report questionnaire evaluating the frequency of self-harming and self-destructive behaviors. Participants rate each item based on their experiences over the past 4 weeks or their current experiences, using a 4-point Likert scale ranging from 1 (almost never) to 4 (always). Total scores range from 20 to 80, with higher scores indicating more frequent or severe self-harming behaviors. Changes in total SHI scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).
6 secondary outcomes
Change in Frequency of Non-Suicidal Self-Injury as Assessed by the Korean Inventory of Statements About Self-Injury (K-ISAS)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Severity of Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Emotion Regulation Difficulties as Assessed by the Difficulties in Emotion Regulation Scale-16 (DERS-16)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Impulsivity as Assessed by the Barratt Impulsiveness Scale-Brief (BIS-Brief)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Depressive Symptom Severity as Assessed by the Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Change in Anxiety Symptoms as Assessed by the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Jae-Won Kim, MD, PhD principal investigator
Seoul National University and Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Self-Injury Intervention Skills Training (ASIST) and Treatment as Usual (TAU) in people with Non-suicidal Self-injury (NSSI) and Adolescent, run by Seoul National University at 1 site in South Korea.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae-Won Kim, MD, PhD (82-2-2072-3648, kimjw412@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Harming Behaviors as Assessed by the Self-Harm Inventory (SHI) (time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)). 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 2 Nov 2026.