AnxietyNCT03684434
Online Cognitive Behaviour Therapy for Depression and Anxiety: Randomized Controlled Trial Varying Treatment Content
A study testing Online MI plus Online CBT and Online CBT in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
Trial summary
Anxiety and depression are prevalent and disabling conditions. Although cognitive behaviour therapy (CBT) has been shown to significantly reduce symptoms of anxiety and depression, access to the service is limited. 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?
- Online MI plus Online CBT and Online CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2018to 14 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is 18 years of age or older
- is a resident of Saskatchewan, Canada
- is experiencing at least mild to moderate symptoms of anxiety and/or depression
- has not been hospitalized within the last year for mental health and/or suicide risk concerns
- is not seeking regular face-to-face therapy for anxiety and/or depression
- has access to a secure computer and the Internet
Show all 9Show fewer
- is comfortable using technology
- is available to work through treatment each week
- is willing to provide a medical contact as emergency contact
Who cannot join
- is younger than 18 years of age
- is not a resident of Saskatchewan, Canada
- is experiencing no symptoms of anxiety and/or depression
- has been hospitalized within the last year for mental health and/or suicide risk concerns
- has unmanaged problems with alcohol, drugs, psychosis, or mania
- is seeking regular face-to-face therapy for anxiety and/or depression
Show all 10Show fewer
- does not have access to a secure computer and the Internet
- is not comfortable using technology
- is not available to work through treatment each week
- is not willing to provide a medical contact as an emergency contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Brief Online Motivational Interviewing Intervention for Enhancing Engagement in Internet-delivered Cognitive Behaviour Therapy
Anxiety and depression are prevalent and disabling conditions. Although cognitive behaviour therapy (CBT) has been shown to significantly reduce symptoms of anxiety and depression, access to the service is limited. Internet-delivered cognitive behaviour therapy (ICBT) represents a novel approach to overcoming access barriers and involves delivering therapeutic content to manage symptoms via structured online lessons. The Online Therapy Unit has been studying the efficacy of ICBT for anxiety and depression and found that ~75% of clients complete treatment and demonstrate large improvement in symptoms. However, recent research suggests that younger clients and clients with higher baseline distress are more likely to dropout of ICBT. While it remains unclear why these clients are more susceptible to attrition, it is plausible that they are experiencing a greater degree ambivalence to change and, thus, terminate treatment as a result. Motivational interviewing (MI) aims to help facilitate clients' intrinsic motivation to change by resolving ambivalence. MI has been integrated into CBT for anxiety to overcome similar concerns of poor treatment retention. Evidence suggests that the integration of MI and CBT further enhances response and completion rates. In the context of online therapy, however, the efficacy of MI remains unclear. In the current trial, the investigators aimed to assess a recently developed online MI pre-treatment (i.e., the Planning for Change lesson). A total of 480 clients (original aim for sample size was 300) applying to transdiagnostic ICBT in routine care were randomly assigned to receive the MI pre-treatment or no pre-treatment (i.e., a waiting period) prior to participating in ICBT (i.e., the Wellbeing Course). The investigators sought to examine: how ICBT with MI compared to standardized ICBT in terms of symptom change, rates of reliable improvement, intervention usage (e.g., number of lessons completed), frequency of motivational language in the first two emails to therapist, and motivation levels. It was hypothesized that there would be a small but significant effect of MI on these variables. Additionally, the investigators aimed to explore if age and severity of baseline distress moderate the effect between MI and ICBT outcomes. Younger clients and clients with higher baseline distress are more likely to drop out of ICBT and, thus, it was further hypothesized that online MI will have a greater impact on these groups.
- Conditions
- Anxiety, Depression
- Being tested
- Online MI plus Online CBT, Online CBT
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Motivational Interviewing, Randomized controlled trial, Pre-treatment, Mental health system
- 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.
Online MI plus Online CBTBehavioural
Also called Planning for Change Lesson plus Wellbeing Course
An online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
Online CBTBehavioural
Also called Wellbeing Course
An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
| Study group | Role | What they receive |
|---|---|---|
| Online MI plus Online CBT | Experimental | An online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. Receives: Behavioral: Online MI plus Online CBT |
| Online CBT | Active comparator | An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. Receives: Behavioral: Online CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motivation levels
Change Questionnaire - 3 Item: Items are summed into a total score. Total score ranges from 0 to 30, with higher scores representing greater self-reported levels of motivation.
Measured: Baseline and week 1
Change in depression symptoms
Patient Health Questionnaire - 9 Item: Items are summed into a total score. Total score ranges from 0 to 27, with higher scores representing more severe self-reported levels of depression.
Measured: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Change in anxiety symptoms
Generalize Anxiety Disorder - 7 Item: Items are summed into a total score. Total score ranges from 0 to 21, with higher scores representing more severe self-reported levels of anxiety.
Measured: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Client engagement in online therapy (i.e., the Wellbeing Course)
Measured by: Number of lessons completed, number of lesson logins, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client
Measured: week 10
Client feedback questions
Administered to only those participants assigned to the Online MI plus ICBT group: A series of rating and open-ended questions developed by the investigators designed to ascertain clients' perceptions of the Planning for Change lesson. Questions are designed to provide both quantitative and qualitative information, and do not include total scores.
Measured: week 1 (following completion of the Planning for Change lesson)
Change in motivation to engage in treatment
Two questions developed by Titov et al. (2010) to measure motivation to engage in ICBT: Both questions are rated on a 1 to 9 scale, with higher scores representing greater self-reported motivation levels. Questions will be independently assessed and, thus, there will be no total score.
Measured: Monday of week 1 and Sunday of week 1
Secondary outcomes (12)
NOTE ABOUT SECONDARY MEASURES
Below secondary outcome measures are routinely given in the Online Therapy Unit but were not of primary interest in the current study.
Measured: weeks 1 to 53
Change in panic symptoms
Measured by Panic Disorder Severity Scale-Self Report: 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: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because PDSS was mistakenly not administered at baseline
Change in social anxiety symptoms
Measured by Social Interaction Anxiety Scale - 6 Item: Items are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social anxiety.
Measured: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SIAS was mistakenly not administered at baseline
Change in social phobia symptoms
Measured by the Social Phobia Scale - 6 Item: Items are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia.
Measured: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SPS was mistakenly not administered at baseline
Change in quality of life symptoms
Measured by EQ-5D-5L: 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: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because EQ-5D-5L was mistakenly not administered at baseline
Psychological Distress
Measured by the Kessler Psychological Distress Scale: Items are summed into a total score. Total scores range between 0 and 50, with higher scores representing more severe self-report psychological distress.
Measured: Baseline, weeks 2, 10, 13, 25, and 53 **K10 outcomes were only collected for half the sample during baseline due to the measure accidentally not being included at the start of recruitment. As such, distress was measured using the PHQ-9 and GAD-7 instead.
Change in disability
Measure by Sheehan Disability Scale-3 Item: Items are summed into a total score. Total scores range between 0 and 30, with higher scores representing greater impairment associated with symptoms.
Measured: Baseline, weeks 2, 10, 13, 25, and 53
Change in post-traumatic symptoms
Measured by Modified Brief Life Events Checklist: The Modified Brief Life Events Checklist consists of two sections. 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, weeks 13, 25, and 53
Changes in treatment costs
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada: 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, week 13, 25, and 53 **Only used to assess for group differences at baseline**
Change in treatment credibility
Measured by Treatment Credibility Questionnaire: Items are summed into a total score. Total scores range between 3 and 27, with higher scores representing greater perceptions of ICBT credibility.
Measured: Baseline and week 10
Therapeutic alliance
Measured by Working Alliance Inventory-Short Form: 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: week 10
Satisfaction with Wellbeing Program assessed by the Internet-CBT Treatment Satisfaction Measure
Measured by Internet-CBT Treatment Satisfaction Measure: A series of yes and no, rating, and open-ended questions developed by the investigators' collaborators. These questions are designed to ascertain clients' satisfaction with the Wellbeing Course and include questions, for example, that pertain to the likelihood of recommending the Wellbeing Course to a friend and whether they learned useful information throughout the course. Questions are designed to provide both quantitative and qualitative information, and do not include a total score.
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start27 Sep 2018
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 480 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 D Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684434
- Sponsor's protocol ID
- 2018-084
- Status last verified
- Jun 2020
- First submitted
- 11 Sep 2018
- Last updated
- 9 Jun 2020
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Brief Online Motivational Interviewing Intervention for Enhancing Engagement in Internet-delivered Cognitive Behaviour Therapy
- ClinicalTrials.gov ID
- NCT03684434
- Acronym / sponsor ID
- 2018-084
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Internet-delivered cognitive behaviour therapy, Motivational Interviewing, Randomized controlled trial, Pre-treatment, Mental health system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 25 Sep 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.
Anxiety and depression are prevalent and disabling conditions. Although cognitive behaviour therapy (CBT) has been shown to significantly reduce symptoms of anxiety and depression, access to the service is limited. Internet-delivered cognitive behaviour therapy (ICBT) represents a novel approach to overcoming access barriers and involves delivering therapeutic content to manage symptoms via structured online lessons. The Online Therapy Unit has been studying the efficacy of ICBT for anxiety and depression and found that ~75% of clients complete treatment and demonstrate large improvement in symptoms. However, recent research suggests that younger clients and clients with higher baseline distress are more likely to dropout of ICBT. While it remains unclear why these clients are more susceptible to attrition, it is plausible that they are experiencing a greater degree ambivalence to change and, thus, terminate treatment as a result. Motivational interviewing (MI) aims to help facilitate clients' intrinsic motivation to change by resolving ambivalence. MI has been integrated into CBT for anxiety to overcome similar concerns of poor treatment retention. Evidence suggests that the integration of MI and CBT further enhances response and completion rates. In the context of online therapy, however, the efficacy of MI remains unclear. In the current trial, the investigators aimed to assess a recently developed online MI pre-treatment (i.e., the Planning for Change lesson). A total of 480 clients (original aim for sample size was 300) applying to transdiagnostic ICBT in routine care were randomly assigned to receive the MI pre-treatment or no pre-treatment (i.e., a waiting period) prior to participating in ICBT (i.e., the Wellbeing Course). The investigators sought to examine: how ICBT with MI compared to standardized ICBT in terms of symptom change, rates of reliable improvement, intervention usage (e.g., number of lessons completed), frequency of motivational language in the first two emails to therapist, and motivation levels. It was hypothesized that there would be a small but significant effect of MI on these variables. Additionally, the investigators aimed to explore if age and severity of baseline distress moderate the effect between MI and ICBT outcomes. Younger clients and clients with higher baseline distress are more likely to drop out of ICBT and, thus, it was further hypothesized that online MI will have a greater impact on these groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online MI plus Online CBT | Experimental | Behavioral: Online MI plus Online CBTAn online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. |
| Online CBT | Active comparator | Behavioral: Online CBTAn 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- is 18 years of age or older
- is a resident of Saskatchewan, Canada
- is experiencing at least mild to moderate symptoms of anxiety and/or depression
- has not been hospitalized within the last year for mental health and/or suicide risk concerns
- is not seeking regular face-to-face therapy for anxiety and/or depression
Key exclusion criteria (10 listed)
- is younger than 18 years of age
- is not a resident of Saskatchewan, Canada
- is experiencing no symptoms of anxiety and/or depression
- has been hospitalized within the last year for mental health and/or suicide risk concerns
- has unmanaged problems with alcohol, drugs, psychosis, or mania
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 |
|---|---|---|
| Online MI plus Online CBTAlso: Planning for Change Lesson plus Wellbeing CourseAn online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. | Behavioural | Online MI plus Online CBT |
| Online CBTAlso: Wellbeing CourseAn 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client. | Behavioural | Online CBT |
Primary outcome
Change in motivation levels
Time frame: Baseline and week 1
Change Questionnaire - 3 Item: Items are summed into a total score. Total score ranges from 0 to 30, with higher scores representing greater self-reported levels of motivation.
Change in depression symptoms
Time frame: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Patient Health Questionnaire - 9 Item: Items are summed into a total score. Total score ranges from 0 to 27, with higher scores representing more severe self-reported levels of depression.
Change in anxiety symptoms
Time frame: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Generalize Anxiety Disorder - 7 Item: Items are summed into a total score. Total score ranges from 0 to 21, with higher scores representing more severe self-reported levels of anxiety.
Client engagement in online therapy (i.e., the Wellbeing Course)
Time frame: week 10
Measured by: Number of lessons completed, number of lesson logins, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client
Client feedback questions
Time frame: week 1 (following completion of the Planning for Change lesson)
Administered to only those participants assigned to the Online MI plus ICBT group: A series of rating and open-ended questions developed by the investigators designed to ascertain clients' perceptions of the Planning for Change lesson. Questions are designed to provide both quantitative and qualitative information, and do not include total scores.
Change in motivation to engage in treatment
Time frame: Monday of week 1 and Sunday of week 1
Two questions developed by Titov et al. (2010) to measure motivation to engage in ICBT: Both questions are rated on a 1 to 9 scale, with higher scores representing greater self-reported motivation levels. Questions will be independently assessed and, thus, there will be no total score.
12 secondary outcomes
NOTE ABOUT SECONDARY MEASURES
Time frame: weeks 1 to 53
Change in panic symptoms
Time frame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because PDSS was mistakenly not administered at baseline
Change in social anxiety symptoms
Time frame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SIAS was mistakenly not administered at baseline
Change in social phobia symptoms
Time frame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SPS was mistakenly not administered at baseline
Change in quality of life symptoms
Time frame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because EQ-5D-5L was mistakenly not administered at baseline
Psychological Distress
Time frame: Baseline, weeks 2, 10, 13, 25, and 53 **K10 outcomes were only collected for half the sample during baseline due to the measure accidentally not being included at the start of recruitment. As such, distress was measured using the PHQ-9 and GAD-7 instead.
Change in disability
Time frame: Baseline, weeks 2, 10, 13, 25, and 53
Change in post-traumatic symptoms
Time frame: Baseline, weeks 13, 25, and 53
Changes in treatment costs
Time frame: Baseline, week 13, 25, and 53 **Only used to assess for group differences at baseline**
Change in treatment credibility
Time frame: Baseline and week 10
Therapeutic alliance
Time frame: week 10
Satisfaction with Wellbeing Program assessed by the Internet-CBT Treatment Satisfaction Measure
Time frame: week 10
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 9 Jun 2020.
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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 D 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 Online MI plus Online CBT and Online CBT 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 9 inclusion and 10 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 9 Jun 2020. 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?
Change in motivation levels (time frame: Baseline and week 1). The study lists 6 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 9 Jun 2020.