DepressionPSYADEPNCT04321525
Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy
A study testing Cognitive-behavioral therapy, Personal Construct Therapy and Personal Construct Therapy with virtual reality in people with Depression, run by University of Barcelona at 2 sites in Spain.
Trial summary
Cognitive Behavioral Therapy (CBT) is the most prestigious psychological treatment for depression. However, not only do we need to increase its efficacy but also to widen the repertoire of evidence-based psychotherapeutic interventions. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive-behavioral therapy, Personal Construct Therapy and Personal Construct Therapy with virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Oct 2021to 31 Jul 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 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants will meet diagnostic criteria for mild or moderate depressive episode according to ICD-10 (current version in the Catalan health system), diagnosed using MINI, and a score above 13 and below 29 on the BDI-II questionnaire.
Who cannot join
- Patients presenting bipolar or other affective disorders (ICD-10), psychotic symptoms, substance abuse, organic brain dysfunction, acute suicidal ideation or mental retardation will be excluded from the study. The presence of other comorbid conditions (anxiety, eating or personality disorders, etc.) will not be cause for exclusion but they will be assessed and recorded and explored statistically. Finally, those who do not have enough level of competence to communicate in Spanish or Catalan, or patients with substantial visual, hearing and cognitive deficits cannot be included
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Barcelona
Barcelona, Catalonia, 08035
Associació Centre Higiene Mental Nou Barris
Barcelona, 08042
About this study
Cognitive Behavioral Therapy (CBT) is the most prestigious psychological treatment for depression. However, not only do we need to increase its efficacy but also to widen the repertoire of evidence-based psychotherapeutic interventions. The importance of the patient's engagement in treatment is highlighted in the literature as a key factor for a good therapeutic outcome over and above the type of therapy. In this sense, personal construct therapy (PCT), with some promising supporting evidence, is particularly suited to fit the personal values and attitudes of each patient. In contrast to CBT, PCT does not educate patients about depression and give them directions on the changes to be made in their dysfunctional behaviors or cognitions. Rather, PCT explores their coherence with respect to the person's sense of identity, their construction of self and others, and works with the conflicts or dilemmas that appear during this conjoint exploration using the Repertory Grid Technique (RGT). In this project, for the first time, the RGT will be implemented using Virtual Reality (VR). This format could be highly appealing for young people, thus facilitating their involvement in therapy. The efficacy of this innovative application of PCT using VR (PCT-VR) will be compared to usual PCT, and to CBT in a randomized clinical trial. The Beck Depression Inventory-II is the primary outcome measure for calculating both statistical and clinical significance, but other measures will also be used at pre-, post-therapy and six-month follow up. The trial will be done in a natural health context, mostly the usual primary care center of each patient, with those who consult during the active period of the study.
Our research group has been working on both depression and personal construct theory for more than two decades (this includes our previous funded projects), particularly with a dilemma-focused intervention aimed to resolve the cognitive conflicts detected with the RGT. By fostering a technological innovation with VR, it is expected to boost the current efficacy of psychotherapy by increasing the engagement of young people and obtaining better outcomes. If these goals are met, a pathological evolution of the patient with its associated personal, health and social costs could be avoided.
Read the detailed description
This project will allow to test the hypothesis that a novel brief psychotherapeutic intervention, personal construct therapy with virtual reality (PCT-VR) will be more efficacious in the treatment of mild-to-moderate depression of young adults than current treatments such as the well-established Cognitive Behavioral Therapy (CBT), and the promissory personal construct therapy (PCT). It is expected that the enhancement of a current psychotherapy with VR, based on the immersive exploration of the patient's self-identity, will increase the positive effects of existing psychological therapies (at least the other therapies included in the study) in terms of symptom reduction of depressive symptoms (primary outcome), and bettering of psychological functioning, wellbeing and satisfaction. It is assumed that the use of the VR device created for this study, will make the treatment more attractive for young adults, this increasing their engagement in the therapy process. It is hypothesized that an immersive exploration of the personal constructs used to perceive self and others will facilitate self-understanding and change. As a secondary hypothesis, it is expected that PCT, thanks to its personalized and non-prescriptive nature, will be more efficacious than CBT. Also, as reflected in the literature, it is expected that the quality of the therapeutic alliance will be associated to outcome, but whether this association varies in its intensity across therapy modalities will be also explored.
General objectives With this project, it is pursued the goal of increasing the efficacy of psychological therapies for mild-to-moderate depression in young adults. It is expected to obtain better clinical results with the promissory and novel treatment modalities (PCT and PCT-VR) than with the current most prestigious CBT. By obtaining supporting evidence for these therapies, the range of psychotherapeutic alternatives for depression will be increased and this will benefit the potential for adapting the interventions to the personal styles, characteristics and preferences of each patient. An optimal personalization of the treatment favors the patient engagement in therapy and strengthens the therapeutic alliance which, in turn, should be reflected in a facilitation of the change process.
Specific objectives
- To assess the efficacy of an innovative VR-enhanced treatment modality of psychotherapy (PCT-VR) which has never been tested before. Differential outcomes will be considered not only in terms of statistical but also clinical significance and remission rates. In addition to the reduction of depressive symptoms our study is aimed also to better psychological functioning, wellbeing and satisfaction with the services provided.
2- To evaluate the efficacy for mild-to-moderate depression in young adults of PCT, a psychotherapeutic approach with some supporting evidence for a variety of disorders and conditions but still insufficient to be considered efficacious for depression.
3- To verify the good levels of efficacy shown by CBT in the treatment of depression, mostly in international studies.
4- To identify baseline variables predicting differential outcome such as symptom severity (also comparing mild with moderate depression), and characteristics of the personal construct system such as the level of cognitive conflict.
5- To gauge the significance of the therapeutic alliance in the different treatment modalities of the study and its influence in the therapeutic outcomes measured.
6- To explore the personal views of patients with respect to the therapy process that they will have experienced as a way to advance our knowledge of the therapy process (including potential adverse effects) of each treatment. To compare this knowledge with the quantitative results of the study might be helpful for a better understanding of the entire process.
- Conditions
- Depression
- Being tested
- Cognitive-behavioral therapy, Personal Construct Therapy, Personal Construct Therapy with virtual reality
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Also called Cognitive therapy
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
Personal Construct TherapyBehavioural
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
Personal Construct Therapy with virtual realityBehavioural
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy (CBT) | Active comparator | Individual Cognitive Behavioral Therapy Receives: Behavioral: Cognitive-behavioral therapy |
| Personal construct therapy (PCT) | Experimental | Individual Personal Construct Therapy Receives: Behavioral: Personal Construct Therapy |
| Personal construct therapy with virtual reality (PCT-VR) | Experimental | Individual Personal Construct Therapy with an immersive virtual reality app Receives: Behavioral: Personal Construct Therapy with virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck depression inventory second edition
Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer \& Brown, 1996). It is a 21-item self-report instrument to assess the existence and severity of symptoms of depression. Both the original and the Spanish version (Sanz, Perdigón, \& Vázquez, 2003) showed good psychometric properties and acceptability.
Measured: BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up
Secondary outcomes (4)
Clinical Outcomes in Routine Evaluation-Outcome Measure
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM; Evans et al, 2002). It is a 34-item self-report questionnaire for the assessment of subjective wellbeing, symptoms or problems, life functioning and risk. It has good psychometric properties (Trujillo et al, 2016) and it has been adapted into Spanish for free distribution (www.ub.edu/terdep/core) . The short version (CORE-SFB) of 18 items will be used for session-to-session monitoring of the therapy process.
Measured: CORE-OM is administered at baseline, and then routinely every session (using short forms versions A and B) until the end of treatment (10 weeks), and 6-month follow-up
- Depression, Anxiety and Stress Scales
Depression, Anxiety and Stress Scales (DASS-21; Lovibond \& Lovibond, 1995). This 21-item version of the DASS comprises 7 items for its three scales (depression, anxiety and stress) which are moderately correlated with each other. The scores for each scale range from 0 to 21. There have been studies of validation with Spanish population finding satisfactory psychometric properties (Bados, Solanas, \& Andrés, 2005).
Measured: DASS-21 is administered at the end of therapy (10 weeks), and 6-month follow-up
Session Rating Scale 3.0
Session Rating Scale 3.0 (SRS 3.0; Duncan et al., 2003). It is a brief questionnaire designed to assess therapeutic alliance at the end of the session. It is composed of 4 items that have to be answered through a visual analog scale (VAS) of 10 centimeters. They measure the appreciation of the relationship with the therapist, agreement with the therapist about the goals and issues discussed in the session, agreement with the method or approach of the therapist, and global assessment of the session. The Spanish version obtained good levels of validity and reliability (Moggia, Niño-Robles, Miller, \& Feixas, 2018)
Measured: SRS 3.0 is administered routinely after every session, through intervention completion (10 weeks), and 6-month follow-up
Change Interview
Change Interview (Elliott, Slatick and Urman, 2001). This semi-structured interview was created to assess the changes produced throughout therapy, the useful aspects, and the adverse effects of interventions from the patient's perspective. The patient is asked about the (positive) changes he/she has experienced with the intervention, as well as the negative changes if there has been any. Questions are also asked about the attribution of such changes, and their probability of occurrence without intervention. Its functions in this study are to identify both changes that patients are aware of (in their own words) which might go unnoticed with standardized questionnaires and adverse effects (too often neglected in psychotherapy research).
Measured: administered at the end of therapy (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start15 Oct 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2024
Why it stopped: COVID-19 pandemic disrupted trial recruitment in 2020-2022. Cooperating healthcare centers lacked resources, and funding was exhausted, necessitating trial termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Oberta de Catalunya
- Responsible party
- Principal investigator, Dr. Guillem Feixas, University of Barcelona
- Investigators
- Guillem Feixas, Ph.D, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321525
- Sponsor's protocol ID
- RTI2018-094294-B-I00
- Acronym
- PSYADEP
- Status last verified
- Dec 2024
- First submitted
- 18 Feb 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for all primary and secondary outcomes, after deidentification
Publications
Montesano A, Medina JC, Paz C, Garcia-Mieres H, Nino-Robles N, Garcia-Grau E, Crespillo JC, Garcia-Gutierrez A, Alabernia-Segura M, Feixas G. Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial. Trials. 2021 Dec 13;22(1):916. doi: 10.1186/s13063-021-05809-1.
PubMed 34903251
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy
- ClinicalTrials.gov ID
- NCT04321525
- Acronym / sponsor ID
- PSYADEP / RTI2018-094294-B-I00
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic disrupted trial recruitment in 2020-2022. Cooperating healthcare centers lacked resources, and funding was exhausted, necessitating trial termination.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Universitat Oberta de Catalunya
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive Behavioral Therapy (CBT) is the most prestigious psychological treatment for depression. However, not only do we need to increase its efficacy but also to widen the repertoire of evidence-based psychotherapeutic interventions. The importance of the patient's engagement in treatment is highlighted in the literature as a key factor for a good therapeutic outcome over and above the type of therapy. In this sense, personal construct therapy (PCT), with some promising supporting evidence, is particularly suited to fit the personal values and attitudes of each patient. In contrast to CBT, PCT does not educate patients about depression and give them directions on the changes to be made in their dysfunctional behaviors or cognitions. Rather, PCT explores their coherence with respect to the person's sense of identity, their construction of self and others, and works with the conflicts or dilemmas that appear during this conjoint exploration using the Repertory Grid Technique (RGT). In this project, for the first time, the RGT will be implemented using Virtual Reality (VR). This format could be highly appealing for young people, thus facilitating their involvement in therapy. The efficacy of this innovative application of PCT using VR (PCT-VR) will be compared to usual PCT, and to CBT in a randomized clinical trial. The Beck Depression Inventory-II is the primary outcome measure for calculating both statistical and clinical significance, but other measures will also be used at pre-, post-therapy and six-month follow up. The trial will be done in a natural health context, mostly the usual primary care center of each patient, with those who consult during the active period of the study.
Our research group has been working on both depression and personal construct theory for more than two decades (this includes our previous funded projects), particularly with a dilemma-focused intervention aimed to resolve the cognitive conflicts detected with the RGT. By fostering a technological innovation with VR, it is expected to boost the current efficacy of psychotherapy by increasing the engagement of young people and obtaining better outcomes. If these goals are met, a pathological evolution of the patient with its associated personal, health and social costs could be avoided.
Detailed description
This project will allow to test the hypothesis that a novel brief psychotherapeutic intervention, personal construct therapy with virtual reality (PCT-VR) will be more efficacious in the treatment of mild-to-moderate depression of young adults than current treatments such as the well-established Cognitive Behavioral Therapy (CBT), and the promissory personal construct therapy (PCT). It is expected that the enhancement of a current psychotherapy with VR, based on the immersive exploration of the patient's self-identity, will increase the positive effects of existing psychological therapies (at least the other therapies included in the study) in terms of symptom reduction of depressive symptoms (primary outcome), and bettering of psychological functioning, wellbeing and satisfaction. It is assumed that the use of the VR device created for this study, will make the treatment more attractive for young adults, this increasing their engagement in the therapy process. It is hypothesized that an immersive exploration of the personal constructs used to perceive self and others will facilitate self-understanding and change. As a secondary hypothesis, it is expected that PCT, thanks to its personalized and non-prescriptive nature, will be more efficacious than CBT. Also, as reflected in the literature, it is expected that the quality of the therapeutic alliance will be associated to outcome, but whether this association varies in its intensity across therapy modalities will be also explored.
General objectives With this project, it is pursued the goal of increasing the efficacy of psychological therapies for mild-to-moderate depression in young adults. It is expected to obtain better clinical results with the promissory and novel treatment modalities (PCT and PCT-VR) than with the current most prestigious CBT. By obtaining supporting evidence for these therapies, the range of psychotherapeutic alternatives for depression will be increased and this will benefit the potential for adapting the interventions to the personal styles, characteristics and preferences of each patient. An optimal personalization of the treatment favors the patient engagement in therapy and strengthens the therapeutic alliance which, in turn, should be reflected in a facilitation of the change process.
Specific objectives
- To assess the efficacy of an innovative VR-enhanced treatment modality of psychotherapy (PCT-VR) which has never been tested before. Differential outcomes will be considered not only in terms of statistical but also clinical significance and remission rates. In addition to the reduction of depressive symptoms our study is aimed also to better psychological functioning, wellbeing and satisfaction with the services provided.
2- To evaluate the efficacy for mild-to-moderate depression in young adults of PCT, a psychotherapeutic approach with some supporting evidence for a variety of disorders and conditions but still insufficient to be considered efficacious for depression.
3- To verify the good levels of efficacy shown by CBT in the treatment of depression, mostly in international studies.
4- To identify baseline variables predicting differential outcome such as symptom severity (also comparing mild with moderate depression), and characteristics of the personal construct system such as the level of cognitive conflict.
5- To gauge the significance of the therapeutic alliance in the different treatment modalities of the study and its influence in the therapeutic outcomes measured.
6- To explore the personal views of patients with respect to the therapy process that they will have experienced as a way to advance our knowledge of the therapy process (including potential adverse effects) of each treatment. To compare this knowledge with the quantitative results of the study might be helpful for a better understanding of the entire process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy (CBT) | Active comparator | Behavioral: Cognitive-behavioral therapyIndividual Cognitive Behavioral Therapy |
| Personal construct therapy (PCT) | Experimental | Behavioral: Personal Construct TherapyIndividual Personal Construct Therapy |
| Personal construct therapy with virtual reality (PCT-VR) | Experimental | Behavioral: Personal Construct Therapy with virtual realityIndividual Personal Construct Therapy with an immersive virtual reality app |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants will meet diagnostic criteria for mild or moderate depressive episode according to ICD-10 (current version in the Catalan health system), diagnosed using MINI, and a score above 13 and below 29 on the BDI-II questionnaire.
Key exclusion criteria (1 listed)
- Patients presenting bipolar or other affective disorders (ICD-10), psychotic symptoms, substance abuse, organic brain dysfunction, acute suicidal ideation or mental retardation will be excluded from the study. The presence of other comorbid conditions (anxiety, eating or personality disorders, etc.) will not be cause for exclusion but they will be assessed and recorded and explored statistically. Finally, those who do not have enough level of competence to communicate in Spanish or Catalan, or patients with substantial visual, hearing and cognitive deficits cannot be included
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 |
|---|---|---|
| Cognitive-behavioral therapyAlso: Cognitive therapy10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session | Behavioural | Cognitive-behavioral therapy (CBT) |
| Personal Construct Therapy10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session | Behavioural | Personal construct therapy (PCT) |
| Personal Construct Therapy with virtual reality10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session | Behavioural | Personal construct therapy with virtual reality (PCT-VR) |
Primary outcome
Change in Beck depression inventory second edition
Time frame: BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up
Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer \& Brown, 1996). It is a 21-item self-report instrument to assess the existence and severity of symptoms of depression. Both the original and the Spanish version (Sanz, Perdigón, \& Vázquez, 2003) showed good psychometric properties and acceptability.
4 secondary outcomes
Clinical Outcomes in Routine Evaluation-Outcome Measure
Time frame: CORE-OM is administered at baseline, and then routinely every session (using short forms versions A and B) until the end of treatment (10 weeks), and 6-month follow-up
- Depression, Anxiety and Stress Scales
Time frame: DASS-21 is administered at the end of therapy (10 weeks), and 6-month follow-up
Session Rating Scale 3.0
Time frame: SRS 3.0 is administered routinely after every session, through intervention completion (10 weeks), and 6-month follow-up
Change Interview
Time frame: administered at the end of therapy (10 weeks)
Results and safety
The study was stopped early (reason given: COVID-19 pandemic disrupted trial recruitment in 2020-2022. Cooperating healthcare centers lacked resources, and funding was exhausted, necessitating trial termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 34903251Montesano A, Medina JC, Paz C, Garcia-Mieres H, Nino-Robles N, Garcia-Grau E, Crespillo JC, Garcia-Gutierrez A, Alabernia-Segura M, Feixas G. Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial. Trials. 2021 Dec 13;22(1):916. doi: 10.1186/s13063-021-05809-1.
- Individual participant dataSharing planned: Yes. Individual participant data for all primary and secondary outcomes, after deidentification
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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.
Guillem Feixas, Ph.D principal investigator
University of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy, Personal Construct Therapy and Personal Construct Therapy with virtual reality in people with Depression, run by University of Barcelona at 2 sites in Spain.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 was stopped early (reason given: COVID-19 pandemic disrupted trial recruitment in 2020-2022. Cooperating healthcare centers lacked resources, and funding was exhausted, necessitating trial termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck depression inventory second edition (time frame: BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up). 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 NCT04321525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.