AnxietyNCT03758599
Exercise in Anxiety and Posttraumatic Stress Disorders
A study testing Climbing, Nordic Walking and Social Contact in people with Anxiety, run by Universitaet Innsbruck at 1 site in Austria.
Trial summary
Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Climbing, Nordic Walking and Social Contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2017to 1 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD-10 diagnosis of Anxiety Disorder or Post Traumatic Stress Disorder: F40, F41, F43.1;
- age range: 18-65
- written informed consent
- stable medication (if needed) for at least 3 weeks
Who cannot join
- acute psychosis or suicidal behaviour
- medical contraindication to physical activity (assessed by a clinician)
- cognitive deficits
- problems with German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial
Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise.
Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD.
Read more
Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c).
Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes.
Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.
Read the detailed description
The proposed research project is designed as a randomized controlled clinical trial with three arms. The efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on primary and secondary study outcome will be investigated (see Figure 1). Patients will be first screened by the outpatient-unit of the Department of Psychosomatics at the Medical University of Innsbruck or remitted through the treating staff network community. When assessed as eligible for the study, a group of up to ten out-patients will be randomly selected and invited to an informative meeting. Patients receive study information and time tables for their group attendances. The intervention will start within the following week and will end four weeks after beginning. Follow-up assessments will take place three and six months after intervention.
In addition to the AD/PTSD symptom screening, secondary study outcomes will be assessed:
- at study inclusion (t1)
- at the end of the intervention (t2)
- three months after the intervention (t3)
- six months after the intervention (t4)
- Conditions
- Anxiety
- Being tested
- Climbing, Nordic Walking, Social Contact
- Keywords
- Anxiety Disorder, Posttraumatic Stress Disorder, Sports intervention
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClimbingProcedure or surgery
All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
Nordic WalkingProcedure or surgery
All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
Social ContactProcedure or surgery
All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
| Study group | Role | What they receive |
|---|---|---|
| Climbing Exercise Group | Experimental | At the beginning of each session, a standardized body-centered, mind-setting warmup of ten minutes will take place. The general warm-up will be followed by climbing specific warm-up, which will consist of bouldering (20-30 minutes). Afterwards the rope climbing session will start. Climbing sessions also contain several sport-specific skill-development training sessions to familiarize the participants with gear and rope management, to acquire footwork and route finding, and to locate good belay spots and resting positions while climbing. At the end of the climbing session a short cool-down of five minutes will be executed. Receives: Procedure: Climbing |
| Aerobic Exercise Group | Experimental | As the climbing exercise group, the aerobic exercise group will start with a ten minutes body-centered, mind-setting warm-up, followed by 60 minutes of Nordic walking and five minutes cool down. A physiotherapist or sport scientist will instruct and guide the group. Nordic walking will be performed at a moderate pace at varying paths. Receives: Procedure: Nordic Walking |
| Social Contact Control Group | Active comparator | Patients allocated to the social contact control group will receive the same amount of social interaction as the exercise groups. A physiotherapist or sport scientist will be present while participants watch movies with relevant content to disease followed by interactive group discussions. This group is required to control for the impact of social contact/support on AD/PTSD and secondary outcomes. Receives: Procedure: Social Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Beck Anxiety Inventory (BAI; Beck \& Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Post Traumatic Stress Disorder Checklist Civil Version (PCL-5; Weathers et al., 2013) The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of PTSD The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of Posttraumatic Stress Disorder
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Secondary outcomes (10)
Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Beck Depression Inventory (BDI-II; Beck et al., 1996) The BDI-II ranges from 0 and 63 points with lower points indicating less symptoms of depression.
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries.
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Quality of life (WHOQOL-BREF; WHOQOL Group, 1998) The WHOQOL-BREF ranges from 5 and 130 points with lower points indicating less quality of life.
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
General Self-Efficacy Scale (GSE; Schwarzer \& Jerusalem, 1995) The GSE ranges from 4 and 40 points with lower points indicating less resources in self efficacy.
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Affective Responses_a
Feeling Scale (FS; Hardy \& Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence.
Measured: 1 minute before each intervention, after 38 minutes, after 75 minutes
Affective Responses_b
Felt Arousal Scale (FAS; Svebak \& Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal.
Measured: 1 minute before each intervention, after 38 minutes, after 75 minutes
Affective Responses_c
The Positive and Negative Affect Scale (PANAS; Watson, Clark, \& Tellegen, 1988) The PANAS measures two subscales, positive affect (points ranging from 10 to 50) and negative affect (points ranging from 10 to 50) Lower points on positive subscale indicates low level of positive affect, low points on negative affect subscale indicates low level of negative affect.
Measured: 1 minute before each intervention, after 75 minutes
Affective Responses_d
Rating of Perceived Exertion (RPE; Borg, 1998)
Measured: 38 minutes after beginning of intervention
Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
tryptophan-kynurenine and the phenylalanine-tyrosine pathways
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
neopterin and pro-inflammatory cytokines
Measured: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Oct 2017
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
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 AnxietyStudies 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
- Model description
- Randomized controlled clinical trial with three arms for the comparison of the efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on symptoms of AD/PTSD, worry symptoms, quality of life, physical activity, health-related resources and affective responses in patients with AD or PTSD.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaet Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
- Investigators
- Barbara Sperner-Unterweger, Prof. MD, Principal investigator, University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758599
- Sponsor's protocol ID
- 256912
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2018
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bichler CS, Niedermeier M, Hufner K, Galffy M, Sperner-Unterweger B, Kopp M. Affective Responses to Both Climbing and Nordic Walking Exercise Are Associated With Intermediate-Term Increases in Physical Activity in Patients With Anxiety and Posttraumatic Stress Disorder - A Randomized Longitudinal Controlled Clinical Pilot Trial. Front Psychiatry. 2022 Jun 9;13:856730. doi: 10.3389/fpsyt.2022.856730. eCollection 2022.
PubMed 35757205
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT03758599
- Acronym / sponsor ID
- 256912
- Conditions
- Anxiety
- Keywords
- Anxiety Disorder, Posttraumatic Stress Disorder, Sports intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaet InnsbruckUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Nov 2018 (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.
Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise.
Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD.
Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c).
Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes.
Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.
Detailed description
The proposed research project is designed as a randomized controlled clinical trial with three arms. The efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on primary and secondary study outcome will be investigated (see Figure 1). Patients will be first screened by the outpatient-unit of the Department of Psychosomatics at the Medical University of Innsbruck or remitted through the treating staff network community. When assessed as eligible for the study, a group of up to ten out-patients will be randomly selected and invited to an informative meeting. Patients receive study information and time tables for their group attendances. The intervention will start within the following week and will end four weeks after beginning. Follow-up assessments will take place three and six months after intervention.
In addition to the AD/PTSD symptom screening, secondary study outcomes will be assessed:
- at study inclusion (t1)
- at the end of the intervention (t2)
- three months after the intervention (t3)
- six months after the intervention (t4)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial with three arms for the comparison of the efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on symptoms of AD/PTSD, worry symptoms, quality of life, physical activity, health-related resources and affective responses in patients with AD or PTSD.
| Arm | Type | Receives |
|---|---|---|
| Climbing Exercise Group | Experimental | Procedure: ClimbingAt the beginning of each session, a standardized body-centered, mind-setting warmup of ten minutes will take place. The general warm-up will be followed by climbing specific warm-up, which will consist of bouldering (20-30 minutes). Afterwards the rope climbing session will start. Climbing sessions also contain several sport-specific skill-development training sessions to familiarize the participants with gear and rope management, to acquire footwork and route finding, and to locate good belay spots and resting positions while climbing. At the end of the climbing session a short cool-down of five minutes will be executed. |
| Aerobic Exercise Group | Experimental | Procedure: Nordic WalkingAs the climbing exercise group, the aerobic exercise group will start with a ten minutes body-centered, mind-setting warm-up, followed by 60 minutes of Nordic walking and five minutes cool down. A physiotherapist or sport scientist will instruct and guide the group. Nordic walking will be performed at a moderate pace at varying paths. |
| Social Contact Control Group | Active comparator | Procedure: Social ContactPatients allocated to the social contact control group will receive the same amount of social interaction as the exercise groups. A physiotherapist or sport scientist will be present while participants watch movies with relevant content to disease followed by interactive group discussions. This group is required to control for the impact of social contact/support on AD/PTSD and secondary outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICD-10 diagnosis of Anxiety Disorder or Post Traumatic Stress Disorder: F40, F41, F43.1;
- age range: 18-65
- written informed consent
- stable medication (if needed) for at least 3 weeks
Key exclusion criteria (4 listed)
- acute psychosis or suicidal behaviour
- medical contraindication to physical activity (assessed by a clinician)
- cognitive deficits
- problems with German language
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 |
|---|---|---|
| ClimbingAll interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates. | Procedure or surgery | Climbing Exercise Group |
| Nordic WalkingAll interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates. | Procedure or surgery | Aerobic Exercise Group |
| Social ContactAll interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates. | Procedure or surgery | Social Contact Control Group |
Primary outcome
Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Beck Anxiety Inventory (BAI; Beck \& Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety
Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Post Traumatic Stress Disorder Checklist Civil Version (PCL-5; Weathers et al., 2013) The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of PTSD The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of Posttraumatic Stress Disorder
10 secondary outcomes
Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Affective Responses_a
Time frame: 1 minute before each intervention, after 38 minutes, after 75 minutes
Affective Responses_b
Time frame: 1 minute before each intervention, after 38 minutes, after 75 minutes
Affective Responses_c
Time frame: 1 minute before each intervention, after 75 minutes
Affective Responses_d
Time frame: 38 minutes after beginning of intervention
Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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 1 Oct 2021.
- Derived from this study: PubMed 35757205Bichler CS, Niedermeier M, Hufner K, Galffy M, Sperner-Unterweger B, Kopp M. Affective Responses to Both Climbing and Nordic Walking Exercise Are Associated With Intermediate-Term Increases in Physical Activity in Patients With Anxiety and Posttraumatic Stress Disorder - A Randomized Longitudinal Controlled Clinical Pilot Trial. Front Psychiatry. 2022 Jun 9;13:856730. doi: 10.3389/fpsyt.2022.856730. eCollection 2022.
- 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.
Barbara Sperner-Unterweger, Prof. MD principal investigator
University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climbing, Nordic Walking and Social Contact in people with Anxiety, run by Universitaet Innsbruck at 1 site in Austria.
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 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 1 Oct 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 Austria. 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 from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) (time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours). 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?
On the ClinicalTrials.gov record for NCT03758599, 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 1 Oct 2021.