DepressionPAPANCT06432959
Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies
A study testing Psychotherapy, Positive Affect Promoting Activities and Psychotherapy in people with Depression and Borderline Personality Disorder, run by Ohio State University at 1 site in United States.
Trial summary
In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Borderline Personality Disorder, Emotion Regulation
- What is being tested?
- Psychotherapy, Positive Affect Promoting Activities and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Apr 2024
- 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 old or older
- residence in the state of Ohio
- able and willing to give informed consent
Who cannot join
- current or past diagnosis of bipolar disorder or a psychotic disorder
- presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
- currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
- if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
- clear indication of secondary gain (e.g., court-ordered treatment)
- current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. In clinics focused on each of these treatments, the investigators will evaluate these treatments with and without the addition of positive affect promoting activities.
Read the detailed description
The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy. One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy.
This study is a two-clinic randomized clinical trial. Eligible participants will be randomized to standard treatment or standard treatment + positive affect promoting activities. A total of 50 participants (25 per condition) will be randomized in a clinic providing CBT for depression. A total of 40 (20 per condition) will be randomized in a clinic providing CBT for problems of emotion dysregulation. Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample. At pre-treatment, 4-weeks, and 12-weeks, participants will complete symptoms measures in addition to measures of diagnosis-relevant processes (e.g., rumination), personality, therapy skills, treatment engagement, and treatment history. Additionally, participants and providers will complete measures before and after each therapy session to assess alliance, engagement, symptoms, skills, and mood. Sessions will be recorded to later code psychotherapy process measures.
CBT. Clients will participate in a course of CBT for depression. CBT consists of a series of structured, collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views (e.g., "I am worthless"). Treatment will be informed by the primary treatment manual for CBT of depression. Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist.
The protocol for CBT will be to have twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. Clients will have the option of consulting with their therapist or another therapist (which would be likely when a therapist is no longer providing treatment for the study) for up to two booster sessions in the six months following their 12-week acute treatment period.
DBT. Clients will participate in a six-month (24 to 26-week) course of DBT. DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. At study end, participants who wish to continue treatment will be provided with referrals in the community or in the clinic, if therapists are available.
Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist. Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT. The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment.
Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities (PAPA) condition or the treatment-as-usual (TAU) condition. Patients in the TAU condition will receive either CBT or DBT as described above. Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Following the first four weeks, therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies (both in session and between sessions).
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Given that there are individual differences in the ways that people appraise various stimuli, it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant. Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include:
- Watch videos of animals (e.g., dogs, pandas, penguins) and babies (e.g., laughing, discovering)
- Eat a piece of candy
- Recall and describe a past positive experience (e.g., talk about success, interest / goal pursuit)
- Describe the positive attributes of the participant
- Engage in gratitude practice
- Do something nice for someone (e.g., write thank you notes for deployed troops, notes of encouragement for children in the hospital, volunteer)
- Listen to music
- Draw or create
- Practice mindfulness, including loving kindness meditations
- Take a walk or dance
- Watch clips of comedians
- Go outside and sit in the sun
- View pictures of loved ones/animals
The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. Participants and therapists will work together to identify activities that reliably lead to feeling joy, curiosity, pride, or love, for example. Then, therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks, learn new things, or regulate their emotions.
- Being tested
- Psychotherapy, Positive Affect Promoting Activities, Psychotherapy
- Medical subject headings
- Depression, Borderline Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy, Positive Affect Promoting ActivitiesBehavioural
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Some examples of positive affect promoting activities are:
- Watch videos of animals and babies
- Eat a piece of candy
- Recall and describe a past positive experience
- Describe the positive attributes of the participant
- Engage in gratitude practice
- Do something nice for someone
The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions.
PsychotherapyBehavioural
Meet with treatment providers individually or in group to learn skills to address symptoms associated with depression and emotion dysregulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Participants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. Receives: Behavioral: Psychotherapy |
| TAU + Positive Affect Promoting Activities | Experimental | Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions. Receives: Behavioral: Psychotherapy, Positive Affect Promoting Activities; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression.
Measured: weekly over 12 weeks
Weekly Change in Positive and Negative Affect Schedule
20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect.
Measured: weekly over 12 weeks
Secondary outcomes (3)
Weekly Change in Impressions of Skills Scale
Measure developed for this study to assess use, understanding, and confidence in using therapy skills. There are seven items, each rated on a scale of 1-7. Higher scores indicate that the participant more fully understood the skills taught in session and is confident they will be able to use the skills outside of session.
Measured: weekly over 12 weeks
Change in Credibility/Expectancy Questionnaire
6 item questionnaire used to assess expectations of treatment with four items measuring confidence or expectations for the treatment (scored 1 - 9) and two items assessing anticipated improvement in symptoms (scored 0 - 100%). Higher scores reflect more confidence and expected improvement.
Measured: 4 weeks
Weekly Change in Working Alliance Inventory
Completed by both participants and providers to assess quality of the therapeutic relationship. This scale has 12-items and each is scored 0 - 6. Higher scores reflect a better therapeutic relationship.
Measured: weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Sep 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Cheavens, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432959
- Sponsor's protocol ID
- 2022B0257
- Acronym
- PAPA
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will consider requests for data sharing, pending approval from our Institutional Review Board (IRB). Note: Individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
- ClinicalTrials.gov ID
- NCT06432959
- Acronym / sponsor ID
- PAPA / 2022B0257
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 29 May 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.
In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. In clinics focused on each of these treatments, the investigators will evaluate these treatments with and without the addition of positive affect promoting activities.
Detailed description
The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy. One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy.
This study is a two-clinic randomized clinical trial. Eligible participants will be randomized to standard treatment or standard treatment + positive affect promoting activities. A total of 50 participants (25 per condition) will be randomized in a clinic providing CBT for depression. A total of 40 (20 per condition) will be randomized in a clinic providing CBT for problems of emotion dysregulation. Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample. At pre-treatment, 4-weeks, and 12-weeks, participants will complete symptoms measures in addition to measures of diagnosis-relevant processes (e.g., rumination), personality, therapy skills, treatment engagement, and treatment history. Additionally, participants and providers will complete measures before and after each therapy session to assess alliance, engagement, symptoms, skills, and mood. Sessions will be recorded to later code psychotherapy process measures.
CBT. Clients will participate in a course of CBT for depression. CBT consists of a series of structured, collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views (e.g., "I am worthless"). Treatment will be informed by the primary treatment manual for CBT of depression. Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist.
The protocol for CBT will be to have twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. Clients will have the option of consulting with their therapist or another therapist (which would be likely when a therapist is no longer providing treatment for the study) for up to two booster sessions in the six months following their 12-week acute treatment period.
DBT. Clients will participate in a six-month (24 to 26-week) course of DBT. DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. At study end, participants who wish to continue treatment will be provided with referrals in the community or in the clinic, if therapists are available.
Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist. Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT. The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment.
Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities (PAPA) condition or the treatment-as-usual (TAU) condition. Patients in the TAU condition will receive either CBT or DBT as described above. Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Following the first four weeks, therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies (both in session and between sessions).
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Given that there are individual differences in the ways that people appraise various stimuli, it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant. Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include:
- Watch videos of animals (e.g., dogs, pandas, penguins) and babies (e.g., laughing, discovering)
- Eat a piece of candy
- Recall and describe a past positive experience (e.g., talk about success, interest / goal pursuit)
- Describe the positive attributes of the participant
- Engage in gratitude practice
- Do something nice for someone (e.g., write thank you notes for deployed troops, notes of encouragement for children in the hospital, volunteer)
- Listen to music
- Draw or create
- Practice mindfulness, including loving kindness meditations
- Take a walk or dance
- Watch clips of comedians
- Go outside and sit in the sun
- View pictures of loved ones/animals
The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. Participants and therapists will work together to identify activities that reliably lead to feeling joy, curiosity, pride, or love, for example. Then, therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks, learn new things, or regulate their emotions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: PsychotherapyParticipants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. |
| TAU + Positive Affect Promoting Activities | Experimental | Behavioral: Psychotherapy, Positive Affect Promoting Activities, Behavioral: PsychotherapyThose assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- residence in the state of Ohio
- able and willing to give informed consent
Key exclusion criteria (6 listed)
- current or past diagnosis of bipolar disorder or a psychotic disorder
- presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
- currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
- if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
- clear indication of secondary gain (e.g., court-ordered treatment)
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 |
|---|---|---|
| Psychotherapy, Positive Affect Promoting ActivitiesThe specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Some examples of positive affect promoting activities are: * Watch videos of animals and babies * Eat a piece of candy * Recall and describe a past positive experience * Describe the positive attributes of the participant * Engage in gratitude practice * Do something nice for someone The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. | Behavioural | TAU + Positive Affect Promoting Activities |
| PsychotherapyMeet with treatment providers individually or in group to learn skills to address symptoms associated with depression and emotion dysregulation | Behavioural | TAU + Positive Affect Promoting Activities, Treatment as Usual |
Primary outcome
Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
Time frame: weekly over 12 weeks
16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression.
Weekly Change in Positive and Negative Affect Schedule
Time frame: weekly over 12 weeks
20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect.
3 secondary outcomes
Weekly Change in Impressions of Skills Scale
Time frame: weekly over 12 weeks
Change in Credibility/Expectancy Questionnaire
Time frame: 4 weeks
Weekly Change in Working Alliance Inventory
Time frame: weekly for 12 weeks
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 22 Jun 2025.
- Individual participant dataSharing planned: No. We will consider requests for data sharing, pending approval from our Institutional Review Board (IRB). Note: Individual participant data (IPD).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy, Positive Affect Promoting Activities and Psychotherapy in people with Depression and Borderline Personality Disorder, run by Ohio State University 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 3 inclusion and 6 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 22 Jun 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. 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?
Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report (time frame: weekly over 12 weeks). 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 22 Jun 2025.