Feedback, PsychologicalNCT03107845
Randomized Controlled Trial to Evaluate Personalized Prediction and Adaptation Tools in Psychotherapy
A study testing Cognitive Behavior Therapy, CBT plus Feedback and CBT plus Feedback plus CST in people with Feedback, Psychological, run by University of Trier at 1 site in Germany.
Trial summary
The research project investigates in a randomized controlled trial the effectiveness as well as moderating and mediating factors of psychometric feedback to therapists. In the intended study a total of 423 patients, who applied for a cognitive-behavioral therapy at the psychotherapy clinic of the University Trier and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Feedback, Psychological
- What is being tested?
- Cognitive Behavior Therapy, CBT plus Feedback and CBT plus Feedback plus CST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2017to 1 May 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One anxiety and/or depressive disorder (ICD-10: F32, F33, F40, F41, F42, F43)
- At least 3 treatment sessions
Who cannot join
- Organic, including symptomatic mental disorders (ICD-10: F00-F09)
- Mental and behavioral disorders due to psychoactive substances (ICD-10: F10-F19)
- Schizophrenia, schizotypal, and delusional disorders (ICD-10: F20-F29)
- Acute suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Effects of Psychometric Feedback on Treatment Outcome and Its Mediators and Moderators in Outpatient Psychotherapy
The research project investigates in a randomized controlled trial the effectiveness as well as moderating and mediating factors of psychometric feedback to therapists. In the intended study a total of 423 patients, who applied for a cognitive-behavioral therapy at the psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety disorder (SCID-interviews), will be included. The patients will be randomly assigned either to one therapist as well as to one of two intervention groups (CG, IG2). An additional intervention group (IG1) will be generated from an existing archivale data set via propensity score matching. Patients of the control group (CG; n = 85) will be monitored concerning psychological impairment but therapists will not be provided with any feedback about the patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists are provided with feedback about the patients self-evaluation in a computerized feedback portal. Therapists of the IG2 will additionally be provided with clinical support tools, which will be developed in this project, on the basis of existing systems. Therapists will also be provided with a personalized treatment recommendation based on similar patients (Nearest Neighbors) at the beginning of treatment.
Besides the general effectiveness of feedback and the clinical support tools for negatively developing patients, further mediating and moderating variables on this feedback effect should be examined: treatment length, frequency of feedback use, therapist effects, therapist's experience, attitude towards feedback as well as congruence of therapist's and patient's evaluation concerning the progress.
Additional procedures will be implemented to assess treatment adherence as well as the reliability of diagnosis and to include it into the analyses.
Read the detailed description
The primary objective of the current project is to investigate several questions of feedback research in psychotherapy with a cluster randomized controlled trial (RCT) with two feedback groups (IG1: Feedback; IG2: Feedback plus CSTs) and one CG with repeated measurements. IG1 will be generated from an existing archival data set via propensity score matching. It adds to previous feedback research a stricter design by investigating another repeated measurement CG as well as a stricter control of treatment integrity. It also includes a structured clinical interview (SCID) and controls for comorbidity (within depression and anxiety). Furthermore, a more severely impaired patient sample is studied and an international outcome instrument is used, which is also often applied in outpatient centers in Germany. This study also investigates the above described moderators (attitudes towards, use of the feedback system, diagnoses) and mediators (therapists' awareness of negative change and treatment length) in a comprehensive model and in one study.
Therefore, the research questions are:
Main questions:
H1: NOT patients in the feedback condition (IG1) show on average better treatment outcome than NOT patients in the CG.
H2: NOT patients in the IG2 (+CSTs) show on average better treatment outcomes than NOT patients of the IG1 (no CSTs but psychometric feedback).
Secondary questions concerning moderators and mediators:
H3: The positive impact of feedback for NOT patients is moderated through the usage of the feedback system and/or the attitudes of the therapist towards feedback.
- H3a: The more frequently and the longer feedback is used, the more aware are therapists for negative change.
- H3b: The more positive the therapists' attitudes towards, the more aware are therapists for negative change.
- H3c: The effects of feedback on patient outcomes do not differ between diagnostic groups (depression and anxiety).
H4: The positive impact of feedback for NOT patients is mediated through therapists' awareness of negative change as well as treatment length
- H4a: The positive impact of feedback for NOT patients is mediated by the therapists' awareness of negative developments of patients.
- H4b: The positive effect of therapists' awareness on treatment outcome is mediated by treatment length (number of sessions).
It is assumed that feedback raises therapists' awareness of negative change. This increased awareness could directly improve treatment outcome through a respective treatment adaption. Given the finding that NOT patients tend to have longer treatments when therapists receive feedback, this effect of increased awareness on treatment outcome could be mediated through treatment length. Accordingly, the essential adaption after being aware of a negative progress would be a higher number of sessions which gives NOT patients more time to improve. However, other adaptions than an increased treatment length are possible and could directly enhance treatment outcome. Regarding the above described moderators it is assumed that the amount of feedback induced awareness as well as the positive effect of feedback on outcome is potentially influenced by therapists' attitude towards feedback, the usage of the feedback system and diagnoses.
Furthermore, effects of feedback are controlled for the following potential influence factors: treatment integrity (adherence, competence), comorbidity, initial impairment, clinical experience as well as experience with the feedback system, non-psychometric feedback and therapist effects (Level 2 variable).
To answer these questions, the following treatment and CSTs will be studied in the outpatient clinic at the University of Trier:
- Control group (CG): Treatment with continuous assessments but without computer based feedback to therapists.
- Intervention group 1(IG1): Treatment with continuous assessments including computer based feedback to therapists after each session. This group is a matched sample.
- Intervention group 2(IG2): Treatment with continuous assessments including computer based feedback to therapists after each session including an alarm for NOT patients and the provision of CST for NOT patients.
- Conditions
- Feedback, Psychological
- Being tested
- Cognitive Behavior Therapy, CBT plus Feedback, CBT plus Feedback plus CST
- Keywords
- CBT, Psychometric Feedback, Clinical Support Tools, Personalized Mental Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Treatments are conducted by cognitive-behavioral therapists in training with different levels of experience as well as licensed cognitive-behavioral therapists with several years of experience. The treatment approach is based on cognitive-behavioral manuals and principles.
CBT plus FeedbackBehavioural
Therapists of the IG1 are provided with information about the initial status concerning symptoms (BSI \& OQ-30), interpersonal functioning (IIP-32 \& OQ-30) as well as diagnoses specific symptoms (GAD-7 or PHQ-9). Beside the status measures, also individual progress information on the symptom level (HSCL-11 each session) is provided to the therapist. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy. This group is a matched sample.
CBT plus Feedback plus CSTBehavioural
Additional to the intervention group "CBT and Feedback" therapists will be provided with additional clinical support tools (CST) which are designed to facilitate treatment selection and treatment adaptation. The causes of deterioration will be assessed and therapists will be provided with additional treatment recommendations and material to help preventing treatment failure for a specific patient. During treatment the clinical support tools will be provided in the problem fields: risk/suicidality, motivation / treatment goals, therapeutic relationship, social support / critical life events, and emotion regulation / self regulation.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy | Active comparator | Cognitive Behavioral Therapy without psychometric Feedback. Receives: Behavioral: Cognitive Behavior Therapy |
| CBT plus Feedback | Experimental | Cognitive Behavioral Therapy (CBT) with Psychometric Feedback Receives: Behavioral: CBT plus Feedback |
| CBT plus Feedback plus CST | Experimental | Cognitive Behavioral Therapy (CBT) with Psychometric Feedback and Clinical Support Tools (CST) Receives: Behavioral: CBT plus Feedback plus CST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006)
The mean of the HSCL-11 is used as the main outcome measure administered before each session.
Measured: through study completion, an average of 50 weeks
Secondary outcomes (4)
Change in Outcome Questionnaire (OQ-30; Lambert et al., 1996)
The mean of the OQ-30 is used as the secondary outcome measure administered every fifth session.
Measured: through study completion, an average of 50 weeks
Change in Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
The sum of the PHQ-9 is used as the secondary outcome measure administered every fifth session.
Measured: through study completion, an average of 50 weeks
Change in Generalized Anxiety Disorder (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
The sum of the GAD-7 is used as the secondary outcome measure administered every fifth session.
Measured: through study completion, an average of 50 weeks
Change in the Brief Symptom Inventory (BSI; Franke, 2000)
The GSI of the BSI is used as a secondary outcome measure administered at the beginning and the end of treatment
Measured: through study completion, an average of 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start15 Apr 2017
- Primary completion15 Oct 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Feedback, PsychologicalStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trier
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Prof. Dr. Wolfgang Lutz, University of Trier
- Investigators
- Wolfgang Lutz, Prof. Dr., Principal investigator, University of Trier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107845
- Sponsor's protocol ID
- LU 660/10-1
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lutz W, De Jong K, Rubel J. Patient-focused and feedback research in psychotherapy: Where are we and where do we want to go? Psychother Res. 2015;25(6):625-32. doi: 10.1080/10503307.2015.1079661. Epub 2015 Sep 16.
PubMed 26376225Lutz W, Rubel J, Schiefele AK, Zimmermann D, Bohnke JR, Wittmann WW. Feedback and therapist effects in the context of treatment outcome and treatment length. Psychother Res. 2015;25(6):647-60. doi: 10.1080/10503307.2015.1053553. Epub 2015 Jul 28.
PubMed 26218788Lutz W, Zimmermann D, Muller VNLS, Deisenhofer AK, Rubel JA. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy: study protocol. BMC Psychiatry. 2017 Aug 24;17(1):306. doi: 10.1186/s12888-017-1464-2.
PubMed 28836954
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effects of Psychometric Feedback on Treatment Outcome and Its Mediators and Moderators in Outpatient Psychotherapy
- ClinicalTrials.gov ID
- NCT03107845
- Acronym / sponsor ID
- LU 660/10-1
- Conditions
- Feedback, Psychological
- Keywords
- CBT, Psychometric Feedback, Clinical Support Tools, Personalized Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of TrierUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Apr 2017 (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 research project investigates in a randomized controlled trial the effectiveness as well as moderating and mediating factors of psychometric feedback to therapists. In the intended study a total of 423 patients, who applied for a cognitive-behavioral therapy at the psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety disorder (SCID-interviews), will be included. The patients will be randomly assigned either to one therapist as well as to one of two intervention groups (CG, IG2). An additional intervention group (IG1) will be generated from an existing archivale data set via propensity score matching. Patients of the control group (CG; n = 85) will be monitored concerning psychological impairment but therapists will not be provided with any feedback about the patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists are provided with feedback about the patients self-evaluation in a computerized feedback portal. Therapists of the IG2 will additionally be provided with clinical support tools, which will be developed in this project, on the basis of existing systems. Therapists will also be provided with a personalized treatment recommendation based on similar patients (Nearest Neighbors) at the beginning of treatment.
Besides the general effectiveness of feedback and the clinical support tools for negatively developing patients, further mediating and moderating variables on this feedback effect should be examined: treatment length, frequency of feedback use, therapist effects, therapist's experience, attitude towards feedback as well as congruence of therapist's and patient's evaluation concerning the progress.
Additional procedures will be implemented to assess treatment adherence as well as the reliability of diagnosis and to include it into the analyses.
Detailed description
The primary objective of the current project is to investigate several questions of feedback research in psychotherapy with a cluster randomized controlled trial (RCT) with two feedback groups (IG1: Feedback; IG2: Feedback plus CSTs) and one CG with repeated measurements. IG1 will be generated from an existing archival data set via propensity score matching. It adds to previous feedback research a stricter design by investigating another repeated measurement CG as well as a stricter control of treatment integrity. It also includes a structured clinical interview (SCID) and controls for comorbidity (within depression and anxiety). Furthermore, a more severely impaired patient sample is studied and an international outcome instrument is used, which is also often applied in outpatient centers in Germany. This study also investigates the above described moderators (attitudes towards, use of the feedback system, diagnoses) and mediators (therapists' awareness of negative change and treatment length) in a comprehensive model and in one study.
Therefore, the research questions are:
Main questions:
H1: NOT patients in the feedback condition (IG1) show on average better treatment outcome than NOT patients in the CG.
H2: NOT patients in the IG2 (+CSTs) show on average better treatment outcomes than NOT patients of the IG1 (no CSTs but psychometric feedback).
Secondary questions concerning moderators and mediators:
H3: The positive impact of feedback for NOT patients is moderated through the usage of the feedback system and/or the attitudes of the therapist towards feedback.
- H3a: The more frequently and the longer feedback is used, the more aware are therapists for negative change.
- H3b: The more positive the therapists' attitudes towards, the more aware are therapists for negative change.
- H3c: The effects of feedback on patient outcomes do not differ between diagnostic groups (depression and anxiety).
H4: The positive impact of feedback for NOT patients is mediated through therapists' awareness of negative change as well as treatment length
- H4a: The positive impact of feedback for NOT patients is mediated by the therapists' awareness of negative developments of patients.
- H4b: The positive effect of therapists' awareness on treatment outcome is mediated by treatment length (number of sessions).
It is assumed that feedback raises therapists' awareness of negative change. This increased awareness could directly improve treatment outcome through a respective treatment adaption. Given the finding that NOT patients tend to have longer treatments when therapists receive feedback, this effect of increased awareness on treatment outcome could be mediated through treatment length. Accordingly, the essential adaption after being aware of a negative progress would be a higher number of sessions which gives NOT patients more time to improve. However, other adaptions than an increased treatment length are possible and could directly enhance treatment outcome. Regarding the above described moderators it is assumed that the amount of feedback induced awareness as well as the positive effect of feedback on outcome is potentially influenced by therapists' attitude towards feedback, the usage of the feedback system and diagnoses.
Furthermore, effects of feedback are controlled for the following potential influence factors: treatment integrity (adherence, competence), comorbidity, initial impairment, clinical experience as well as experience with the feedback system, non-psychometric feedback and therapist effects (Level 2 variable).
To answer these questions, the following treatment and CSTs will be studied in the outpatient clinic at the University of Trier:
- Control group (CG): Treatment with continuous assessments but without computer based feedback to therapists.
- Intervention group 1(IG1): Treatment with continuous assessments including computer based feedback to therapists after each session. This group is a matched sample.
- Intervention group 2(IG2): Treatment with continuous assessments including computer based feedback to therapists after each session including an alarm for NOT patients and the provision of CST for NOT patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior TherapyCognitive Behavioral Therapy without psychometric Feedback. |
| CBT plus Feedback | Experimental | Behavioral: CBT plus FeedbackCognitive Behavioral Therapy (CBT) with Psychometric Feedback |
| CBT plus Feedback plus CST | Experimental | Behavioral: CBT plus Feedback plus CSTCognitive Behavioral Therapy (CBT) with Psychometric Feedback and Clinical Support Tools (CST) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One anxiety and/or depressive disorder (ICD-10: F32, F33, F40, F41, F42, F43)
- At least 3 treatment sessions
Key exclusion criteria (4 listed)
- Organic, including symptomatic mental disorders (ICD-10: F00-F09)
- Mental and behavioral disorders due to psychoactive substances (ICD-10: F10-F19)
- Schizophrenia, schizotypal, and delusional disorders (ICD-10: F20-F29)
- Acute suicidality
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 Behavior TherapyTreatments are conducted by cognitive-behavioral therapists in training with different levels of experience as well as licensed cognitive-behavioral therapists with several years of experience. The treatment approach is based on cognitive-behavioral manuals and principles. | Behavioural | Cognitive Behavior Therapy |
| CBT plus FeedbackTherapists of the IG1 are provided with information about the initial status concerning symptoms (BSI \& OQ-30), interpersonal functioning (IIP-32 \& OQ-30) as well as diagnoses specific symptoms (GAD-7 or PHQ-9). Beside the status measures, also individual progress information on the symptom level (HSCL-11 each session) is provided to the therapist. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy. This group is a matched sample. | Behavioural | CBT plus Feedback |
| CBT plus Feedback plus CSTAdditional to the intervention group "CBT and Feedback" therapists will be provided with additional clinical support tools (CST) which are designed to facilitate treatment selection and treatment adaptation. The causes of deterioration will be assessed and therapists will be provided with additional treatment recommendations and material to help preventing treatment failure for a specific patient. During treatment the clinical support tools will be provided in the problem fields: risk/suicidality, motivation / treatment goals, therapeutic relationship, social support / critical life events, and emotion regulation / self regulation. | Behavioural | CBT plus Feedback plus CST |
Primary outcome
Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006)
Time frame: through study completion, an average of 50 weeks
The mean of the HSCL-11 is used as the main outcome measure administered before each session.
4 secondary outcomes
Change in Outcome Questionnaire (OQ-30; Lambert et al., 1996)
Time frame: through study completion, an average of 50 weeks
Change in Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: through study completion, an average of 50 weeks
Change in Generalized Anxiety Disorder (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
Time frame: through study completion, an average of 50 weeks
Change in the Brief Symptom Inventory (BSI; Franke, 2000)
Time frame: through study completion, an average of 50 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 28 Apr 2021.
- Background: PubMed 26376225Lutz W, De Jong K, Rubel J. Patient-focused and feedback research in psychotherapy: Where are we and where do we want to go? Psychother Res. 2015;25(6):625-32. doi: 10.1080/10503307.2015.1079661. Epub 2015 Sep 16.
- Background: PubMed 26218788Lutz W, Rubel J, Schiefele AK, Zimmermann D, Bohnke JR, Wittmann WW. Feedback and therapist effects in the context of treatment outcome and treatment length. Psychother Res. 2015;25(6):647-60. doi: 10.1080/10503307.2015.1053553. Epub 2015 Jul 28.
- Derived from this study: PubMed 28836954Lutz W, Zimmermann D, Muller VNLS, Deisenhofer AK, Rubel JA. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy: study protocol. BMC Psychiatry. 2017 Aug 24;17(1):306. doi: 10.1186/s12888-017-1464-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Lutz, Prof. Dr. principal investigator
University of Trier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy, CBT plus Feedback and CBT plus Feedback plus CST in people with Feedback, Psychological, run by University of Trier at 1 site in Germany.
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 2 inclusion and 4 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 28 Apr 2021. 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 Germany. 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?
Change in 11-item Short version of Hopkins' Symptom Checklist (HSCL-11; Lutz, Tholen, Schürch, & Berking, 2006) (time frame: through study completion, an average of 50 weeks). 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 NCT03107845, which also lists 3 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 28 Apr 2021.