Atrial FibrillationNCT04962932
Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation
A study testing Internet-deliviered exposure-based CBT and Internet-delivered stress management treatment in people with Atrial Fibrillation and Arrythmia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF), controlling for expectancy of improvement and attention from a caregiver, using an… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Arrythmia
- What is being tested?
- Internet-deliviered exposure-based CBT and Internet-delivered stress management treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSweden
- Study dates
- 13 Aug 2021to 5 Oct 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb);
- Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening;
- Age 18-75 years;
- On optimal medical treatment;
- Able to read and write in Swedish.
Who cannot join
- Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%);
- Significant valvular disease;
- Planned ablation for AF or ablation within 3 months before assessment;
- Other severe medical illness;
- Any medical restriction to physical exercise;
- Severe psychiatric disorder, severe depression, or risk of suicide;
- Alcohol dependency;
- Previous participation in any AF-CBT study conducted by the research group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control
The aim of this study is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT).
Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.
- Conditions
- Atrial Fibrillation, Arrythmia
- Being tested
- Internet-deliviered exposure-based CBT, Internet-delivered stress management treatment
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-deliviered exposure-based CBTBehavioural
The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.
Internet-delivered stress management treatmentBehavioural
The intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered exposure-focused CBT | Experimental | Internet-delivered CBT over 10 weeks The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that aim to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. Receives: Behavioral: Internet-deliviered exposure-based CBT |
| Internet-delivered stress management treatment | Active comparator | Stress management treatment for 10 weeks Participants randomized to The Stress Management Treatment will receive 10 weeks of stress managemen including relaxation technics, standard life style advice regarding physical activity, sleep and and standardized AF-information in line with current guidelines for AF. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. Receives: Behavioral: Internet-delivered stress management treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).
Measured: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).
Measured: From baseline to 9 months
Secondary outcomes (30)
Cardiac Anxiety Questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: From baseline to 10 weeks
Cardiac Anxiety Questionnaire (CAQ)
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: From baseline to 9 months
AF-avoidance behavior questionnaire
Form measuring AF-specific avoidance- and control behaviors, developed by the research group
Measured: From baseline to 10 weeks
AF-avoidance behavior questionnaire
Form measuring AF-specific avoidance- and control behaviors, developed by the research group
Measured: From baseline to 9 months
AF-avoidance behavior questionnaire modified for weekly assessment
4 items from the AF-avoidance behavior questionnaire
Measured: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment
Short Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 10 weeks
Short Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 9 months
Atrial Fibrillation Severity Scale (4 items)
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking
Measured: From baseline to 10 weeks
Atrial Fibrillation Severity Scale (4 items)
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking
Measured: From baseline to 9 months
The Godin-Shepard Leisure-Time Physical Activity Questionnaire
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
Measured: From baseline to 10 weeks
The Godin-Shepard Leisure-Time Physical Activity Questionnaire
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
Measured: From baseline to 9 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 10 weeks
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 9 months
Patient Health Questionnaire-2
Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression.
Measured: From baseline to 10 weeks
Patient Health Questionnaire-2
Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression.
Measured: From baseline to 9 months
Perceived Stress Scale (4 items version)
Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress
Measured: From baseline to 10 weeks
Perceived Stress Scale (4 items version)
Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress
Measured: From baseline to 9 months
Generalized Anxiety Disorder-2 (GAD-2)
General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.
Measured: From baseline to 10 weeks
Generalized Anxiety Disorder-2
General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.
Measured: From baseline to 9 months
Insomnia Severity Index (5 items)
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Measured: From baseline to 10 weeks
Insomnia Severity Index (5 items)
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Measured: From Baseline to 9 months
Perceived Competence Scale
Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence
Measured: From baseline to 10 weeks
Perceived Competence Scale
Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence
Measured: From baseline to 9 months
Client Satisfaction Questionnaire
Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.
Measured: 10 weeks from baseline
Adverse events
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Measured: 10 weeks from baseline
Adverse events
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Measured: 9 months from baseline
Symptoms Checklist Severity and Frequency Scale (SCL)
AF-related symptoms
Measured: From baseline to 10 weeks
Symptoms Checklist Severity and Frequency Scale (SCL)
AF-related symptoms measured in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 9 months
AFFS/SCL-4
4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT
Measured: Weekly from baseline to 10 weeks
AFFS/SCL-4
4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT
Measured: From baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start13 Aug 2021
- Primary completion31 Mar 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
- Investigators
- Brjann Ljotsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962932
- Sponsor's protocol ID
- AF RCT 2
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control
- ClinicalTrials.gov ID
- NCT04962932
- Acronym / sponsor ID
- AF RCT 2
- Conditions
- Atrial Fibrillation, Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 15 Jul 2021 (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 aim of this study is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT).
Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered exposure-focused CBT | Experimental | Behavioral: Internet-deliviered exposure-based CBTInternet-delivered CBT over 10 weeks The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that aim to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. |
| Internet-delivered stress management treatment | Active comparator | Behavioral: Internet-delivered stress management treatmentStress management treatment for 10 weeks Participants randomized to The Stress Management Treatment will receive 10 weeks of stress managemen including relaxation technics, standard life style advice regarding physical activity, sleep and and standardized AF-information in line with current guidelines for AF. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb);
- Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening;
- Age 18-75 years;
- On optimal medical treatment;
- Able to read and write in Swedish.
Key exclusion criteria (8 listed)
- Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%);
- Significant valvular disease;
- Planned ablation for AF or ablation within 3 months before assessment;
- Other severe medical illness;
- Any medical restriction to physical exercise;
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 |
|---|---|---|
| Internet-deliviered exposure-based CBTThe intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist. | Behavioural | Internet-delivered exposure-focused CBT |
| Internet-delivered stress management treatmentThe intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm. | Behavioural | Internet-delivered stress management treatment |
Primary outcome
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
Time frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment
Time frame: From baseline to 9 months
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).
30 secondary outcomes
Cardiac Anxiety Questionnaire (CAQ)
Time frame: From baseline to 10 weeks
Cardiac Anxiety Questionnaire (CAQ)
Time frame: From baseline to 9 months
AF-avoidance behavior questionnaire
Time frame: From baseline to 10 weeks
AF-avoidance behavior questionnaire
Time frame: From baseline to 9 months
AF-avoidance behavior questionnaire modified for weekly assessment
Time frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment
Short Form Health Survey (SF-12)
Time frame: From baseline to 10 weeks
Short Form Health Survey (SF-12)
Time frame: From baseline to 9 months
Atrial Fibrillation Severity Scale (4 items)
Time frame: From baseline to 10 weeks
Atrial Fibrillation Severity Scale (4 items)
Time frame: From baseline to 9 months
The Godin-Shepard Leisure-Time Physical Activity Questionnaire
Time frame: From baseline to 10 weeks
The Godin-Shepard Leisure-Time Physical Activity Questionnaire
Time frame: From baseline to 9 months
Body Sensation Questionnaire
Time frame: From baseline to 10 weeks
Body Sensation Questionnaire
Time frame: From baseline to 9 months
Patient Health Questionnaire-2
Time frame: From baseline to 10 weeks
Patient Health Questionnaire-2
Time frame: From baseline to 9 months
Perceived Stress Scale (4 items version)
Time frame: From baseline to 10 weeks
Perceived Stress Scale (4 items version)
Time frame: From baseline to 9 months
Generalized Anxiety Disorder-2 (GAD-2)
Time frame: From baseline to 10 weeks
Generalized Anxiety Disorder-2
Time frame: From baseline to 9 months
Insomnia Severity Index (5 items)
Time frame: From baseline to 10 weeks
Insomnia Severity Index (5 items)
Time frame: From Baseline to 9 months
Perceived Competence Scale
Time frame: From baseline to 10 weeks
Perceived Competence Scale
Time frame: From baseline to 9 months
Client Satisfaction Questionnaire
Time frame: 10 weeks from baseline
Adverse events
Time frame: 10 weeks from baseline
Adverse events
Time frame: 9 months from baseline
Symptoms Checklist Severity and Frequency Scale (SCL)
Time frame: From baseline to 10 weeks
Symptoms Checklist Severity and Frequency Scale (SCL)
Time frame: From baseline to 9 months
AFFS/SCL-4
Time frame: Weekly from baseline to 10 weeks
AFFS/SCL-4
Time frame: From baseline to 9 months
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 11 Oct 2023.
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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.
Brjann Ljotsson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-deliviered exposure-based CBT and Internet-delivered stress management treatment in people with Atrial Fibrillation and Arrythmia, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 8 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 11 Oct 2023. 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 Sweden. 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?
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment (time frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]). 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 11 Oct 2023.