AnxietyNCT03957330
Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy
A study testing Internet-delivered cognitive behaviour therapy in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
Trial summary
Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Internet-delivered cognitive behaviour therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2019to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Endorse symptoms of anxiety or depression
- Resident of Saskatchewan
- Access to a computer and the Internet
Who cannot join
- Have a severe psychiatric illness (e.g. psychosis)
- Assessed as being at high risk of suicide
- Report severe problems with alcohol or drugs
- Report severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
Official title: Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.
In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).
Read the detailed description
Based on past research of ICBT in routine care, patients and therapists have expressed an interest in "personalizing" the delivery of ICBT, for example, by increasing the amount of therapist support available (from once a week to twice a week) to reflect the unique needs and preferences of the patients. Patients also express an interest in personalizing "therapy messages". One current barrier to offering more personalized messages, however, is that patients do not consistently provide information on their use of new treatment strategies, as well as strengths and challenges of using strategies. As a result, therapists find it difficult to personalize their messages. One method of overcoming this difficulty is to systematically ask patients to reflect on their use of treatment strategies (e.g., monitoring thoughts, challenging thoughts, controlled breathing, pleasant activities, and exposure) through questionnaires rather than relying on patients to provide this information in emails. Another factor that could moderate ICBT efficacy is therapist location. Some therapists who provide ICBT work in a specialized unit where there is primary focus on ICBT and daily attention to following ICBT guidelines. Other therapists deliver ICBT from community mental health clinics where the primary focus of the setting is on face-to-face care and there is lower familiarity with ICBT. It is possible that ICBT may be more effectively delivered in a setting where the primary focus is on ICBT.
- Conditions
- Anxiety, Depression
- Being tested
- Internet-delivered cognitive behaviour therapy
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Randomized controlled trial, Therapist contact, Online therapy, Community mental health
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behaviour therapyBehavioural
All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client.
| Study group | Role | What they receive |
|---|---|---|
| Community Mental Health Clinic | Experimental | In this arm, clients will be assigned to therapists working in a community mental health clinic in Saskatchewan where the focus of the setting is primarily on face-to-face treatment and ICBT makes up a small component of the workload in the clinic. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
| Once a week therapist contact | Experimental | In once a week treatment, therapists will email their clients once a week on a pre-determined day. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
| Reflection Questionnaire | Experimental | In the reflection questionnaire, patients will be asked to complete the following questions five times during the treatment period (beginning lesson 2-5 and then at the point they complete post-questionnaires):
1. How much of the lesson were you able to review?
2. How much effort were you able to put into the lesson?
3. How difficult was the lesson?
4. Please share any difficulties you had with the lesson.
5. How understandable was the lesson?
6. How helpful did you find the lesson?
7. Please describe an example of what you learned.
8. To what extent have you continued to use strategies from previous lessons
9. If applicable, please provide an example of what you are working on from previous lessons
10. Please indicate which Additional Resources you reviewed this week.
11. If applicable, please share any skills you are working on from the Additional Resources. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
| Specialized Internet Therapy Clinic | Experimental | In this arm, clients will be assigned to therapists working in a specialized internet therapy clinic where the therapists only deliver ICBT. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
| Twice a week therapist contact | Experimental | In twice a week treatment, therapists will email their clients twice a week on pre-determined days. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
| No Reflection Questionnaire | Experimental | In this arm, no reflection questions will be asked of clients receiving ICBT. Receives: Behavioral: Internet-delivered cognitive behaviour therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9-item (PHQ-9)
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Measured: Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
Generalized Anxiety Disorder 7-item (GAD-7)
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Measured: Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
Secondary outcomes (12)
Panic Disorder Severity Scale Self-report
Change in panic symptoms. Items are summed into a total score. Total scores range between 0 and 28, with higher scores representing more severe self-reported symptoms of panic.
Measured: Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)
Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 48, with higher scores representing more severe self-reported symptoms of social anxiety
Measured: Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
PTSD Check List 5
Change in post-traumatic symptoms. The measure consists of 20 questions rated 0 to 4; higher scores indicate more trauma symptoms The first section assesses for exposure to a traumatic event using a checklist question. If the client endorses exposure to a traumatic event, they are provided the second section, which assesses severity of trauma symptoms. Items are summed into a total score, which can range between 0 and 80. Higher scores represent more severe self-reported symptoms of trauma.
Measured: Baseline, week 8 and 3-, 6-, and 12-month follow-up
Short Health Anxiety Inventory-14
Change in health anxiety. 14 items with higher scores indicating higher levels of self-reported health anxiety.
Measured: Baseline, week 8 and 3-, 6-, and 12-month follow-up
Kessler Psychological Distress
Change in psychological distress. Measured by 10-item scale rated 0 to 4; total score is created by summing items; higher scores signify greater psychological distress
Measured: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Quality of life questionnaire (EQ-ED-5L)
Change in quality of life. Items are summed into six sub-total scores. The first five sub-total scores respectively assess various domains of quality of life (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Each of the five sub-total scores range between 1 and 5, with higher scores representing greater self-reported severity and impairment in these various domains. The last sub-total score provides an overall index of health and can range between 0 and 100, with higher scores representing better self-reported health.
Measured: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Sheehan Disability Scale 3-item
Change in disability. Measure consists of 3 items rated 0 to 10 and summed to create total score, with higher scores indicating greater disability
Measured: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Change in treatment costs. A series of yes and no, rating, and frequency questions that are designed to ascertain the volume of medical consumption and productivity losses associated with mental health problems. Questions are independently analyzed and, therefore, the TIP-C does not include a total score.
Measured: Baseline and 3-, 6-, and 12-month follow-up
Treatment Credibility Questionnaire
Change in treatment credibility. 4 items are summed into a total score. Higher scores representing greater perceptions of ICBT credibility.
Measured: Baseline, week 8, and 3-month follow-up
Working Alliance Inventory Short-Form
Measures therapeutic alliance. Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond). Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.
Measured: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Treatment Engagement
Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient
Measured: Week 8
Treatment Satisfaction and Negative Effects Questionnaires
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 May 2019
- Primary completion20 May 2021
- Study completion20 May 2021
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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957330
- Sponsor's protocol ID
- 2019-038
- Status last verified
- Nov 2021
- First submitted
- 16 May 2019
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sapkota RP, Peynenburg V, Dear BF, Titov N, Hadjistavropoulos HD. Engagement with homework in an Internet-delivered therapy predicts reduced anxiety and depression symptoms: A latent growth curve analysis. J Consult Clin Psychol. 2023 Feb;91(2):112-117. doi: 10.1037/ccp0000775. Epub 2022 Nov 17.
PubMed 36395032
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
- ClinicalTrials.gov ID
- NCT03957330
- Acronym / sponsor ID
- 2019-038
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Randomized controlled trial, Therapist contact, Online therapy, Community mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 21 May 2019 (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.
Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.
In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).
Detailed description
Based on past research of ICBT in routine care, patients and therapists have expressed an interest in "personalizing" the delivery of ICBT, for example, by increasing the amount of therapist support available (from once a week to twice a week) to reflect the unique needs and preferences of the patients. Patients also express an interest in personalizing "therapy messages". One current barrier to offering more personalized messages, however, is that patients do not consistently provide information on their use of new treatment strategies, as well as strengths and challenges of using strategies. As a result, therapists find it difficult to personalize their messages. One method of overcoming this difficulty is to systematically ask patients to reflect on their use of treatment strategies (e.g., monitoring thoughts, challenging thoughts, controlled breathing, pleasant activities, and exposure) through questionnaires rather than relying on patients to provide this information in emails. Another factor that could moderate ICBT efficacy is therapist location. Some therapists who provide ICBT work in a specialized unit where there is primary focus on ICBT and daily attention to following ICBT guidelines. Other therapists deliver ICBT from community mental health clinics where the primary focus of the setting is on face-to-face care and there is lower familiarity with ICBT. It is possible that ICBT may be more effectively delivered in a setting where the primary focus is on ICBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Community Mental Health Clinic | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn this arm, clients will be assigned to therapists working in a community mental health clinic in Saskatchewan where the focus of the setting is primarily on face-to-face treatment and ICBT makes up a small component of the workload in the clinic. |
| Once a week therapist contact | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn once a week treatment, therapists will email their clients once a week on a pre-determined day. |
| Reflection Questionnaire | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn the reflection questionnaire, patients will be asked to complete the following questions five times during the treatment period (beginning lesson 2-5 and then at the point they complete post-questionnaires): 1. How much of the lesson were you able to review? 2. How much effort were you able to put into the lesson? 3. How difficult was the lesson? 4. Please share any difficulties you had with the lesson. 5. How understandable was the lesson? 6. How helpful did you find the lesson? 7. Please describe an example of what you learned. 8. To what extent have you continued to use strategies from previous lessons 9. If applicable, please provide an example of what you are working on from previous lessons 10. Please indicate which Additional Resources you reviewed this week. 11. If applicable, please share any skills you are working on from the Additional Resources. |
| Specialized Internet Therapy Clinic | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn this arm, clients will be assigned to therapists working in a specialized internet therapy clinic where the therapists only deliver ICBT. |
| Twice a week therapist contact | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn twice a week treatment, therapists will email their clients twice a week on pre-determined days. |
| No Reflection Questionnaire | Experimental | Behavioral: Internet-delivered cognitive behaviour therapyIn this arm, no reflection questions will be asked of clients receiving ICBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Endorse symptoms of anxiety or depression
- Resident of Saskatchewan
- Access to a computer and the Internet
Key exclusion criteria (4 listed)
- Have a severe psychiatric illness (e.g. psychosis)
- Assessed as being at high risk of suicide
- Report severe problems with alcohol or drugs
- Report severe cognitive impairment
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-delivered cognitive behaviour therapyAll clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client. | Behavioural | Community Mental Health Clinic, No Reflection Questionnaire, Once a week therapist contact, Reflection Questionnaire, Specialized Internet Therapy Clinic, Twice a week therapist contact |
Primary outcome
Patient Health Questionnaire 9-item (PHQ-9)
Time frame: Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
12 secondary outcomes
Panic Disorder Severity Scale Self-report
Time frame: Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)
Time frame: Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
PTSD Check List 5
Time frame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
Short Health Anxiety Inventory-14
Time frame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
Kessler Psychological Distress
Time frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Quality of life questionnaire (EQ-ED-5L)
Time frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Sheehan Disability Scale 3-item
Time frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Time frame: Baseline and 3-, 6-, and 12-month follow-up
Treatment Credibility Questionnaire
Time frame: Baseline, week 8, and 3-month follow-up
Working Alliance Inventory Short-Form
Time frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
Treatment Engagement
Time frame: Week 8
Treatment Satisfaction and Negative Effects Questionnaires
Time frame: Week 8
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 18 Nov 2021.
- Derived from this study: PubMed 36395032Sapkota RP, Peynenburg V, Dear BF, Titov N, Hadjistavropoulos HD. Engagement with homework in an Internet-delivered therapy predicts reduced anxiety and depression symptoms: A latent growth curve analysis. J Consult Clin Psychol. 2023 Feb;91(2):112-117. doi: 10.1037/ccp0000775. Epub 2022 Nov 17.
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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.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
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-delivered cognitive behaviour therapy in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
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 18 Nov 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 Canada. 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?
Patient Health Questionnaire 9-item (PHQ-9) (time frame: Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up). 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 NCT03957330, 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 18 Nov 2021.