Mental Health Wellness 1NCT04615741
Finding Wellness in the Pandemic
A study testing Trauma Informed Yoga and Trauma Informed Psychotherapy in people with Mental Health Wellness 1 and Addiction, run by University of Lethbridge at 1 site in Canada.
Trial summary
There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Addiction, Stress, Psychological
- What is being tested?
- Trauma Informed Yoga and Trauma Informed Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2020to 20 Apr 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between 18-75 years living in Alberta, Canada
- Need to have reliable access to the internet, a device with a webcam for the next 2 months
- Need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic
Who cannot join
- Non-community dwelling
- Do not currently reside within Alberta, Canada
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Health and Wellness During COVID-19
There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). While online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. As highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. A way to offset cost while maintaining effectiveness is to offer MHSU programs to groups online, rather than individually. In 2019, the investigators launched an RCT to test gender-stratified group interventions to address MHSU among community-based Indigenous and non-Indigenous adults in southern Alberta. The investigators implemented the interventions with more than 200 adults before the study was paused due to COVID-19.
Read the detailed description
The primary objective of this project is to adapt two existing mental health and substance use interventions and RCT for online delivery, COVID-19 impacts, and province-wide spread. The second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group. The investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to COVID-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours like substance use may be impacting health. The third objective is to examine the impacts of the interventions on adults with pre-existing MHSU issues, and those with previous experiences that may make them more susceptible to MHSU problems during COVID-19. The investigators will track other supports the participants engage during the study and the perceived impacts of these supports on the outcomes with the goal of shedding light on how to best match COVID-19 related services to adults who need them the most.
- Conditions
- Mental Health Wellness 1, Addiction, Stress, Psychological, Covid19
- Being tested
- Trauma Informed Yoga, Trauma Informed Psychotherapy
- Medical subject headings
- Behavior, Addictive, Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Informed YogaBehavioural
One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).
Trauma Informed PsychotherapyBehavioural
Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).
| Study group | Role | What they receive |
|---|---|---|
| Trauma Informed Yoga | Experimental | Participants will receive 8 x 60 min group-based yoga sessions, delivered synchronously over Zoom. Receives: Behavioral: Trauma Informed Yoga |
| Trauma Informed Psychotherapy | Experimental | Participants will receive 8 x 90 min group-based psychotherapy sessions, delivered synchronously over Zoom. Receives: Behavioral: Trauma Informed Psychotherapy |
| Control | No intervention | These participants will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tobacco Use
Participants will be asked to self-report if tobacco use has changed during the pandemic via a 5-point likert. Options range from increased a lot to decreased a lot. If participants indicate their tobacco use has changed, they will be asked to identify the primary reason for this change. Changes in tobacco use will be re-assessed at each time point.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Alcohol Use
Past year alcohol consumption will be assessed through the Alcohol Use Disorder Identification Test (AUDIT). Scores on the AUDIT range from 0 to 40; a score over 8 is indicative of problematic or hazardous alcohol use. Changes in alcohol consumption since the beginning of the pandemic will be identified through a 5-point likert. Changes in alcohol use will be re-assessed at each time point.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Drug Use
Past year drug use will be assessed through the Drug Use Disorders Identification Test (DUDIT). Possible scores on the DUDIT range from 0 to 44; scores greater than 2 or 6 are indicative of risky or harmful drug habits for women and men, respectively. A score of 25 or more suggests the individual is probably heavily dependent on drugs. Participants will also be asked to identify which drugs they currently use, the main reasons for using drugs, and whether their drug use has changed during the pandemic. Changes in drug use will be re-assessed at each time point.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Gambling
Gambling will be assessed via the 9-item Problem Gambling Severity Index (PGSI). The items are measured on a 5-point likert with frequencies from "less than once a month" to "daily or almost daily". A cut-score ≥5 will be used (lower scores indicative of non-problem gambling); the PGSI has a high internal consistency (α = 0.86) and is considered the measure of choice for non-clinical use.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Post-Traumatic Stress Symptoms
A revised version of the Primary Care - Post Traumatic Stress Disorder - 5 (PC-PTSD-5) scale will be assessed to determine experiences of trauma in relation to COVID-19. The scale was revised to specifically ask about COVID-19. Scores range from 0 (no risk) to 5 (high risk). A cut-score of 3 will be used to differentiate high- and low-risk scores. The PC-PTSD has good sensitivity (r = 0.78) and sensitivity (r = 0.87).
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Depression Symptoms
Depression will be screened using the 10-item Centre for Epidemiological Studies Depression Scale (CES-D-10). The CES-D-10 is a short self-report scale to measure depressive symptoms in a general population. Psychometric evaluation has shown the CES-D-10 to have high internal consistency, though with variability across populations (Cronbach's α = 0.71 to 0.90) and good construct validity (r = 0.78).
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Anxiety Symptoms
The 6-item State-Trait Anxiety Inventory (STAI-6) will be used to measure anxiety reflective of both adverse situations (state anxiety) and personality traits associated with higher levels of anxiety (trait anxiety). STAI-6 produces scores like its longer 20-item version, showing good reliability (Cronbach's α = 0.82) with sensitivity to differing degrees of anxiety. Possible scores range from 20 to 80; "normal scores" range from 34 to 36. Higher scores represent higher amount of anxiety.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Secondary outcomes (7)
Changes in Eating Behaviour
Changes in eating behaviours will be assessed by questions asking if food consumption and unhealthy food consumption have changed since the onset of the pandemic via a 5-point likert scale (increased a lot to decreased a lot). If participants indicate they have changed their food consumption, a qualitative question will ask them to describe why they think their behaviour has changed.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Sleeping Behaviour
Participants will be asked to rate how the quantity and quality of their sleep has changed since the pandemic started via 5-point likert scales (increased a lot to decreased a lot).
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Physical Activity
Physical activity will be assessed through the International Physical Activity Questionnaire - Short Form. The questionnaire asks about frequency and duration of vigorous (VPA) and moderate physical activity (MPA) over the past 7 days. Weekly Metabolic Equivalents (MET) minutes will be calculated based on responses. Participants will be categorized into high (>1500 MET min/week with 3+ days of VPA or >3000 METmin/week with 7+ days of MVPA); medium (5+ days of 20+ minutes of VPA per day, 5+ days with 30+ minutes of MPA per day, or 5+ days of MVPA that achieves 600+ MET min/week); low (participant does not meet other cut points).
Frequency and duration of walking and sitting time are also assessed. The IPAQ has good reliability and criterion validity. Participants will also be asked if their PA and sedentary behaviour levels have changed during the pandemic (5-point likert; options: increased a lot to decreased a lot).
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Resilience
The 10-item Connor-Davidson Resilience Scale (CD-RISC 10) is a widely used measure to assess self-perceived resilience. Evaluations of the CD-RISC 10 have shown good internal consistency (Cronbach's α = 0.85), a strong positive association with the longer 25-item CD-RISC (r = 0.92). Scores range from 0 to 40; a higher score is indicative of higher resilience.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Self-Esteem
Self-esteem will be measured using the 10-item Rosenberg Self Esteem Scale. The scale is a widely used measure that correlates well with other measures of self-esteem and has strong internal consistency (0.92) and test-retest reliability (0.88). Scores range from 4 to 40; a higher score indicates higher self esteem. Participants will also be asked how their self-esteem has changed since the beginning of the pandemic.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Loneliness
Loneliness will be evaluated using a shortened (3 item) version of the UCLA Loneliness Scale. This scale asks about feelings of companionship, being left out, and being isolated from others in the last month, with a 3-item list of answer options (hardly ever, some of the time, often). This scale has good reliability (r = 0.73), validity, and internal consistency (Cronbach's α = 0.84-0.94). The scale also showed convergent validity with other commonly used measures of loneliness. Scores range from 1 to 9; higher scores indicate higher levels of loneliness.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Dissociative Experiences
The Brief Dissociative Experiences Scale is an 8-item tool that assesses the severity of dissociative experiences in adults. The scale items are summed and averaged to describe the severity of dissociative experiences as none (0), mild (1), moderate (2), severe (3), or extreme (4). The brief scale was found to be reliable, easy to use, and clinically useful in the DSM-5 Field Trials. Scores range from 0 to 32; a higher score indicates a greater severity of dissociative experiences.
Measured: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start9 Nov 2020
- Primary completion22 Jan 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lethbridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Currie, University of Lethbridge
- Investigators
- Cheryl Currie, PhD, Principal investigator, University of Lethbridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615741
- Sponsor's protocol ID
- 2020-096
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data relevant to the researcher's research question may be shared upon a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health and Wellness During COVID-19
- ClinicalTrials.gov ID
- NCT04615741
- Acronym / sponsor ID
- 2020-096
- Conditions
- Mental Health Wellness 1, Addiction, Stress, Psychological, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of LethbridgeUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 4 Nov 2020 (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.
There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). While online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. As highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. A way to offset cost while maintaining effectiveness is to offer MHSU programs to groups online, rather than individually. In 2019, the investigators launched an RCT to test gender-stratified group interventions to address MHSU among community-based Indigenous and non-Indigenous adults in southern Alberta. The investigators implemented the interventions with more than 200 adults before the study was paused due to COVID-19.
Detailed description
The primary objective of this project is to adapt two existing mental health and substance use interventions and RCT for online delivery, COVID-19 impacts, and province-wide spread. The second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group. The investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to COVID-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours like substance use may be impacting health. The third objective is to examine the impacts of the interventions on adults with pre-existing MHSU issues, and those with previous experiences that may make them more susceptible to MHSU problems during COVID-19. The investigators will track other supports the participants engage during the study and the perceived impacts of these supports on the outcomes with the goal of shedding light on how to best match COVID-19 related services to adults who need them the most.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma Informed Yoga | Experimental | Behavioral: Trauma Informed YogaParticipants will receive 8 x 60 min group-based yoga sessions, delivered synchronously over Zoom. |
| Trauma Informed Psychotherapy | Experimental | Behavioral: Trauma Informed PsychotherapyParticipants will receive 8 x 90 min group-based psychotherapy sessions, delivered synchronously over Zoom. |
| Control | No intervention | –These participants will not receive an intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between 18-75 years living in Alberta, Canada
- Need to have reliable access to the internet, a device with a webcam for the next 2 months
- Need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic
Key exclusion criteria (2 listed)
- Non-community dwelling
- Do not currently reside within Alberta, Canada
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 |
|---|---|---|
| Trauma Informed YogaOne licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min). | Behavioural | Trauma Informed Yoga |
| Trauma Informed PsychotherapyTwo licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min). | Behavioural | Trauma Informed Psychotherapy |
Primary outcome
Changes in Tobacco Use
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Participants will be asked to self-report if tobacco use has changed during the pandemic via a 5-point likert. Options range from increased a lot to decreased a lot. If participants indicate their tobacco use has changed, they will be asked to identify the primary reason for this change. Changes in tobacco use will be re-assessed at each time point.
Changes in Alcohol Use
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Past year alcohol consumption will be assessed through the Alcohol Use Disorder Identification Test (AUDIT). Scores on the AUDIT range from 0 to 40; a score over 8 is indicative of problematic or hazardous alcohol use. Changes in alcohol consumption since the beginning of the pandemic will be identified through a 5-point likert. Changes in alcohol use will be re-assessed at each time point.
Changes in Drug Use
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Past year drug use will be assessed through the Drug Use Disorders Identification Test (DUDIT). Possible scores on the DUDIT range from 0 to 44; scores greater than 2 or 6 are indicative of risky or harmful drug habits for women and men, respectively. A score of 25 or more suggests the individual is probably heavily dependent on drugs. Participants will also be asked to identify which drugs they currently use, the main reasons for using drugs, and whether their drug use has changed during the pandemic. Changes in drug use will be re-assessed at each time point.
Changes in Gambling
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Gambling will be assessed via the 9-item Problem Gambling Severity Index (PGSI). The items are measured on a 5-point likert with frequencies from "less than once a month" to "daily or almost daily". A cut-score ≥5 will be used (lower scores indicative of non-problem gambling); the PGSI has a high internal consistency (α = 0.86) and is considered the measure of choice for non-clinical use.
Changes in Post-Traumatic Stress Symptoms
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
A revised version of the Primary Care - Post Traumatic Stress Disorder - 5 (PC-PTSD-5) scale will be assessed to determine experiences of trauma in relation to COVID-19. The scale was revised to specifically ask about COVID-19. Scores range from 0 (no risk) to 5 (high risk). A cut-score of 3 will be used to differentiate high- and low-risk scores. The PC-PTSD has good sensitivity (r = 0.78) and sensitivity (r = 0.87).
Changes in Depression Symptoms
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Depression will be screened using the 10-item Centre for Epidemiological Studies Depression Scale (CES-D-10). The CES-D-10 is a short self-report scale to measure depressive symptoms in a general population. Psychometric evaluation has shown the CES-D-10 to have high internal consistency, though with variability across populations (Cronbach's α = 0.71 to 0.90) and good construct validity (r = 0.78).
Changes in Anxiety Symptoms
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
The 6-item State-Trait Anxiety Inventory (STAI-6) will be used to measure anxiety reflective of both adverse situations (state anxiety) and personality traits associated with higher levels of anxiety (trait anxiety). STAI-6 produces scores like its longer 20-item version, showing good reliability (Cronbach's α = 0.82) with sensitivity to differing degrees of anxiety. Possible scores range from 20 to 80; "normal scores" range from 34 to 36. Higher scores represent higher amount of anxiety.
7 secondary outcomes
Changes in Eating Behaviour
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Sleeping Behaviour
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Physical Activity
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Resilience
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Self-Esteem
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Loneliness
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Changes in Dissociative Experiences
Time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
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 29 Apr 2021.
- Individual participant dataSharing planned: Yes. De-identified data relevant to the researcher's research question may be shared upon a reasonable request
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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.
Cheryl Currie, PhD principal investigator
University of Lethbridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Informed Yoga and Trauma Informed Psychotherapy in people with Mental Health Wellness 1 and Addiction, run by University of Lethbridge 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 3 inclusion and 2 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Changes in Tobacco Use (time frame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up). The study lists 7 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 29 Apr 2021.