WellbeingNCT04728958
Reflective Tasks With Healthcare Workers During COVID-19
A study testing Gratitude in people with Wellbeing and Psychological Distress, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
The healthcare workforce is amongst the most stressed in the United Kingdom (UK). The Coronavirus (COVID-19) health pandemic has increased depression, anxiety, insomnia and distress in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellbeing, Psychological Distress, Emotional Distress
- What is being tested?
- Gratitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff working in a healthcare environment during the COVID-19 health pandemic, in clinical or non-clinical roles
- Basic understanding of the English language
Who cannot join
- Those engaged in other research projects
- Those without access to an electronic device to complete measures on
- Those without access to an email address
- Those receiving any other form of psychological intervention
- People who cannot commit to engage in a 4-week intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying the Effect of Written Reflective Tasks With Healthcare Staff Working During the COVID-19 Health Pandemic
The healthcare workforce is amongst the most stressed in the United Kingdom (UK). The Coronavirus (COVID-19) health pandemic has increased depression, anxiety, insomnia and distress in this population. Gratitude interventions have been shown to improve wellbeing, alongside reducing risk factors associated with the aforementioned mental health conditions. This online Randomised Control Trial of 219 healthcare staff, will investigate the effects of a gratitude intervention on wellbeing (gratitude, positive affect, happiness) and psychological distress (depression and negative affect). Means of pre- and post-outcome measures of two groups (gratitude journal and control) will be assessed for differences utilising t-tests.
Read the detailed description
The healthcare workforce is amongst the most stressed in the UK, with 40.3% of staff feeling unwell as a result of work-related stress in the past year. This is steadily increasing each year, rising 3.5% from 36.8% since 2016. Chronic stress can cause psychological health problems, including low mood, anxiety and insomnia. Unfortunately, only 29.3% of staff across the NHS felt their trust took positive action on health and wellbeing, which may contribute to and prolong this continued rise in work-related stress.
With the COVID-19 health pandemic adding additional pressure to the NHS, healthcare workers (HCWs) are at further risk of mental health problems, including post-traumatic stress disorder, depression and substance misuse, as evident from historical health pandemics. Furthermore, preliminary data from China during the COVID-19 health pandemic indicated frontline HCWs experienced depression (50.4%), anxiety (44.6%), insomnia (34%) and distress (71.5%). A systematic review identified risk factors for increased psychological distress of HCWs during a health pandemic: being female, a nurse and experiencing stigmatised attitudes from the general public, as well as being quarantined. Perceived control and social support were associated with lower distress. Recommendations were made, to encourage a sense of autonomy (with information and resources), increase social support and to initiate public health campaigns with accurate facts, to reduce stigma and distress.
Positive Psychology Interventions (PPIs) are one approach for promoting autonomy and reducing distress, by increasing positive emotions, behaviours, and/or thoughts, thereby increasing the wellbeing of an individual. Positive psychology focuses on optimism, positive attitude and gratitude, to encourage creativity, improve happiness and reduce mental barriers to productivity, as opposed to focusing on 'problems'. PPIs include gratitude journals, using affirmations, strength focussing exercises and mindful meditations. PPIs in workplaces have improved performance, job wellbeing, engagement and other areas, whilst reducing negative performance and negative job wellbeing.
PPIs have focused on gratitude as a target for improving wellbeing, due to the inverse relationship found between gratitude and burnout. Burnout is a state of emotional and physical exhaustion, cynicism and detachment from work, caused by prolonged stress. Gratitude is a positive, social emotion, similar to appreciation, which can either be state (of being) or trait (dispositional). State gratitude is experienced when undeserved acts of kindness or generosity are given freely by another person. Whereas trait gratitude is viewed as a characteristic of a person, that varies in intensity and frequency throughout their daily life. Gratitude interventions have found improvements (with a small to medium effect size) in quality of relationships, wellbeing and optimism, alongside job satisfaction . Furthermore, a reduction in anxiety, depression and negative affect is also evident.
Gratitude interventions utilise both expression and self-reflection as their methodological properties. Expression includes giving small tokens of appreciation or paying gratitude visits. Self-reflection includes writing personal gratitude lists or journals. Gratitude lists were as effective as clinical therapies when working with excessive worry. Whereas, sharing a gratitude letter was not as effective at improving gratitude, furthermore expression of gratitude immediately induced feelings of embarrassment and discomfort. However, increases in elevation were noted here, namely improved job performance, connectedness, empowerment and autonomy. The reduced effectiveness of this expressive gratitude intervention, may be due to barriers in engagement with the intervention, including the expected awkwardness of the situation and the 'gratitude expresser's' mood.
Effectiveness of gratitude interventions in improving gratitude is likely to be affected by both traits of participants and specificities of the intervention, such as length. Research found trait gratitude moderated the effectiveness of the gratitude intervention in increasing gratitude. This supports the resistance hypothesis, suggesting that those who are predisposed to experience gratitude will not benefit from a gratitude intervention. Irrespective of gratitude moderation, wellbeing significantly improved. The duration of the intervention may also have an impact on effectiveness. Research found higher life satisfaction, more gratitude and an improved positive affect in HCWs, after writing a gratitude diary bi-weekly over 4-weeks. Whereas a shorter 5-day intervention in the workplace, using a similar journaling methodology, was not effective at improving gratitude. This may be explained by research, which found a cumulative improvement in gratitude and happiness over 8-weeks of grateful letter writing, indicating gratitude interventions are required to be of a reasonable length in order to be effective.
HCWs are suffering from psychological distress as a result of the COVID-19 health pandemic. It is vital interventions are offered to support their wellbeing. Gratitude interventions are effective at improving wellbeing and reducing psychological distress, namely the risk factors associated with psychological distress in HCWs at present. Self-reflective gratitude interventions, over a period of weeks are effective at improving gratitude with HCWs, without inducing embarrassment, discomfort or barriers to engagement. However, it is not clear if there are differences in effectiveness dependent upon the methodological properties of the intervention.
This study will aim to investigate the effects of a gratitude intervention with HCWs, with a view to increasing state gratitude and psychological wellbeing (subjective happiness and positive affect), whilst reducing psychological distress (negative affect and depression).
Objectives
- To investigate if gratitude interventions are effective at increasing state gratitude in HCWs
- To investigate if gratitude interventions are effective at reducing psychological distress and improving wellbeing in HCWs
- To investigate if high baseline trait gratitude is a moderator of changes in state gratitude, psychological distress and wellbeing after a gratitude intervention
Hypotheses
- A gratitude intervention will increase state gratitude in HCWs
- A gratitude intervention will improve wellbeing (positive affect and subjective happiness) and reduce psychological distress (depression and negative affect) in HCWs
- High levels of trait gratitude will moderate the outcomes
- Conditions
- Wellbeing, Psychological Distress, Emotional Distress, Depression, Happiness, Affect
- Being tested
- Gratitude
- Keywords
- Gratitude
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GratitudeBehavioural
Also called Gratitude Letter, Gratitude Diary, Gratitude Journal, Appreciation Letter
A positive psychology intervention using expressions of gratitude
| Study group | Role | What they receive |
|---|---|---|
| Gratitude Journal | Experimental | Participants will be given instructions and asked to write a gratitude journal about their week, focusing upon what they are grateful for. Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times). Receives: Behavioral: Gratitude |
| Weekly Diary | Placebo comparator | Participants will be given instructions and asked to write a diary about their week, focusing upon both the good and the bad they have experienced that week. Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times). Receives: Behavioral: Gratitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Level
Patient Health Questionnaire-9 (PHQ-9). This 9-item questionnaire, uses a 4-point likert scale to measure depression level. Minimum score = 0; maximum score = 27. Higher scores indicate higher levels of depression. Positive change scores indicates a worse outcome.
Measured: Pre- to post-intervention (28 days)
Change in Subjective Happiness Level
Subjective Happiness Scale (SHS). This 4-item questionnaire, uses a 7-point likert scale to measure happiness level. Minimum score = 7; maximum score = 28. Higher scores indicate higher subjective happiness levels. Positive change scores indicates a better outcome.
Measured: Pre- to post-intervention (28 days)
Secondary outcomes (4)
Change in State Gratitude
Gratitude Adjective Checklist (GAC). This 3-item measures of state gratitude uses a 5-point likert scale. Minimum score = 3; maximum score = 15. Higher scores indicate higher levels of state gratitude. A positive change score indicates a better outcome.
Measured: Pre- to post-intervention (28 days)
State Gratitude Score
Gratitude Adjective Checklist (GAC). This 3-item measures of state gratitude uses a 5-point likert scale. Minimum score = 3; maximum score = 15. Higher scores indicate higher levels of state gratitude. A positive change score indicates a better outcome.
Measured: Weekly (Day 1, Day 7, Day 14, Day 28)
Change in Trait Gratitude
The gratitude Questionnaire-6 (GQ-6). This 6-item measure of trait gratitude uses a 7-point likert scale. Minimum score = 6; maximum score = 42. Higher scores indicate higher levels of Trait gratitude. A positive change score indicates a better outcome.
Measured: Pre- to post-intervention (28 days)
Trait Gratitude score
The gratitude Questionnaire-6 (GQ-6). This 6-item measure of trait gratitude uses a 7-point likert scale. Minimum score = 6; maximum score = 42. Higher scores indicate higher levels of Trait gratitude.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start19 Mar 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies 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
- Model description
- T-tests compare the mean differences between groups split across the two IVs (intervention \& time), due to the between factors and within factors levels of the two IVs. Descriptive Statistics \& t-tests will be used to compare and assess cumulative gratitude week-by-week
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, York Teaching Hospitals NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Vicky Lamb, MSc, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728958
- Sponsor's protocol ID
- 170732
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be stored securely on the UniDrive, in a shared folder between the principal investigator and the research supervisor. Raw data will also be stored on the Qualtrics system, under a password protected log-in. Study results will be available in the University of Sheffield Online Research Data (ORDA) hub once completed. Sensitive and personal information will not be available as the key linking participant numbers to the personal will be destroyed once the study is completed. The data available will be completely anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effect of Written Reflective Tasks With Healthcare Staff Working During the COVID-19 Health Pandemic
- ClinicalTrials.gov ID
- NCT04728958
- Acronym / sponsor ID
- 170732
- Conditions
- Wellbeing, Psychological Distress, Emotional Distress, Depression, Happiness, Affect
- Keywords
- Gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, York Teaching Hospitals NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Jan 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 healthcare workforce is amongst the most stressed in the United Kingdom (UK). The Coronavirus (COVID-19) health pandemic has increased depression, anxiety, insomnia and distress in this population. Gratitude interventions have been shown to improve wellbeing, alongside reducing risk factors associated with the aforementioned mental health conditions. This online Randomised Control Trial of 219 healthcare staff, will investigate the effects of a gratitude intervention on wellbeing (gratitude, positive affect, happiness) and psychological distress (depression and negative affect). Means of pre- and post-outcome measures of two groups (gratitude journal and control) will be assessed for differences utilising t-tests.
Detailed description
The healthcare workforce is amongst the most stressed in the UK, with 40.3% of staff feeling unwell as a result of work-related stress in the past year. This is steadily increasing each year, rising 3.5% from 36.8% since 2016. Chronic stress can cause psychological health problems, including low mood, anxiety and insomnia. Unfortunately, only 29.3% of staff across the NHS felt their trust took positive action on health and wellbeing, which may contribute to and prolong this continued rise in work-related stress.
With the COVID-19 health pandemic adding additional pressure to the NHS, healthcare workers (HCWs) are at further risk of mental health problems, including post-traumatic stress disorder, depression and substance misuse, as evident from historical health pandemics. Furthermore, preliminary data from China during the COVID-19 health pandemic indicated frontline HCWs experienced depression (50.4%), anxiety (44.6%), insomnia (34%) and distress (71.5%). A systematic review identified risk factors for increased psychological distress of HCWs during a health pandemic: being female, a nurse and experiencing stigmatised attitudes from the general public, as well as being quarantined. Perceived control and social support were associated with lower distress. Recommendations were made, to encourage a sense of autonomy (with information and resources), increase social support and to initiate public health campaigns with accurate facts, to reduce stigma and distress.
Positive Psychology Interventions (PPIs) are one approach for promoting autonomy and reducing distress, by increasing positive emotions, behaviours, and/or thoughts, thereby increasing the wellbeing of an individual. Positive psychology focuses on optimism, positive attitude and gratitude, to encourage creativity, improve happiness and reduce mental barriers to productivity, as opposed to focusing on 'problems'. PPIs include gratitude journals, using affirmations, strength focussing exercises and mindful meditations. PPIs in workplaces have improved performance, job wellbeing, engagement and other areas, whilst reducing negative performance and negative job wellbeing.
PPIs have focused on gratitude as a target for improving wellbeing, due to the inverse relationship found between gratitude and burnout. Burnout is a state of emotional and physical exhaustion, cynicism and detachment from work, caused by prolonged stress. Gratitude is a positive, social emotion, similar to appreciation, which can either be state (of being) or trait (dispositional). State gratitude is experienced when undeserved acts of kindness or generosity are given freely by another person. Whereas trait gratitude is viewed as a characteristic of a person, that varies in intensity and frequency throughout their daily life. Gratitude interventions have found improvements (with a small to medium effect size) in quality of relationships, wellbeing and optimism, alongside job satisfaction . Furthermore, a reduction in anxiety, depression and negative affect is also evident.
Gratitude interventions utilise both expression and self-reflection as their methodological properties. Expression includes giving small tokens of appreciation or paying gratitude visits. Self-reflection includes writing personal gratitude lists or journals. Gratitude lists were as effective as clinical therapies when working with excessive worry. Whereas, sharing a gratitude letter was not as effective at improving gratitude, furthermore expression of gratitude immediately induced feelings of embarrassment and discomfort. However, increases in elevation were noted here, namely improved job performance, connectedness, empowerment and autonomy. The reduced effectiveness of this expressive gratitude intervention, may be due to barriers in engagement with the intervention, including the expected awkwardness of the situation and the 'gratitude expresser's' mood.
Effectiveness of gratitude interventions in improving gratitude is likely to be affected by both traits of participants and specificities of the intervention, such as length. Research found trait gratitude moderated the effectiveness of the gratitude intervention in increasing gratitude. This supports the resistance hypothesis, suggesting that those who are predisposed to experience gratitude will not benefit from a gratitude intervention. Irrespective of gratitude moderation, wellbeing significantly improved. The duration of the intervention may also have an impact on effectiveness. Research found higher life satisfaction, more gratitude and an improved positive affect in HCWs, after writing a gratitude diary bi-weekly over 4-weeks. Whereas a shorter 5-day intervention in the workplace, using a similar journaling methodology, was not effective at improving gratitude. This may be explained by research, which found a cumulative improvement in gratitude and happiness over 8-weeks of grateful letter writing, indicating gratitude interventions are required to be of a reasonable length in order to be effective.
HCWs are suffering from psychological distress as a result of the COVID-19 health pandemic. It is vital interventions are offered to support their wellbeing. Gratitude interventions are effective at improving wellbeing and reducing psychological distress, namely the risk factors associated with psychological distress in HCWs at present. Self-reflective gratitude interventions, over a period of weeks are effective at improving gratitude with HCWs, without inducing embarrassment, discomfort or barriers to engagement. However, it is not clear if there are differences in effectiveness dependent upon the methodological properties of the intervention.
This study will aim to investigate the effects of a gratitude intervention with HCWs, with a view to increasing state gratitude and psychological wellbeing (subjective happiness and positive affect), whilst reducing psychological distress (negative affect and depression).
Objectives
- To investigate if gratitude interventions are effective at increasing state gratitude in HCWs
- To investigate if gratitude interventions are effective at reducing psychological distress and improving wellbeing in HCWs
- To investigate if high baseline trait gratitude is a moderator of changes in state gratitude, psychological distress and wellbeing after a gratitude intervention
Hypotheses
- A gratitude intervention will increase state gratitude in HCWs
- A gratitude intervention will improve wellbeing (positive affect and subjective happiness) and reduce psychological distress (depression and negative affect) in HCWs
- High levels of trait gratitude will moderate the outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- T-tests compare the mean differences between groups split across the two IVs (intervention \& time), due to the between factors and within factors levels of the two IVs. Descriptive Statistics \& t-tests will be used to compare and assess cumulative gratitude week-by-week
| Arm | Type | Receives |
|---|---|---|
| Gratitude Journal | Experimental | Behavioral: GratitudeParticipants will be given instructions and asked to write a gratitude journal about their week, focusing upon what they are grateful for. Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times). |
| Weekly Diary | Placebo comparator | Behavioral: GratitudeParticipants will be given instructions and asked to write a diary about their week, focusing upon both the good and the bad they have experienced that week. Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff working in a healthcare environment during the COVID-19 health pandemic, in clinical or non-clinical roles
- Basic understanding of the English language
Key exclusion criteria (5 listed)
- Those engaged in other research projects
- Those without access to an electronic device to complete measures on
- Those without access to an email address
- Those receiving any other form of psychological intervention
- People who cannot commit to engage in a 4-week intervention study
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 |
|---|---|---|
| GratitudeAlso: Gratitude Letter, Gratitude Diary, Gratitude Journal, Appreciation LetterA positive psychology intervention using expressions of gratitude | Behavioural | Gratitude Journal, Weekly Diary |
Primary outcome
Change in Depression Level
Time frame: Pre- to post-intervention (28 days)
Patient Health Questionnaire-9 (PHQ-9). This 9-item questionnaire, uses a 4-point likert scale to measure depression level. Minimum score = 0; maximum score = 27. Higher scores indicate higher levels of depression. Positive change scores indicates a worse outcome.
Change in Subjective Happiness Level
Time frame: Pre- to post-intervention (28 days)
Subjective Happiness Scale (SHS). This 4-item questionnaire, uses a 7-point likert scale to measure happiness level. Minimum score = 7; maximum score = 28. Higher scores indicate higher subjective happiness levels. Positive change scores indicates a better outcome.
4 secondary outcomes
Change in State Gratitude
Time frame: Pre- to post-intervention (28 days)
State Gratitude Score
Time frame: Weekly (Day 1, Day 7, Day 14, Day 28)
Change in Trait Gratitude
Time frame: Pre- to post-intervention (28 days)
Trait Gratitude score
Time frame: Pre-intervention
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 24 May 2022.
- Individual participant dataSharing planned: No. IPD will be stored securely on the UniDrive, in a shared folder between the principal investigator and the research supervisor. Raw data will also be stored on the Qualtrics system, under a password protected log-in. Study results will be available in the University of Sheffield Online Research Data (ORDA) hub once completed. Sensitive and personal information will not be available as the key linking participant numbers to the personal will be destroyed once the study is completed. The data available will be completely anonymised.
Related trials for Wellbeing
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Active, not recruiting
MEST : A School- Based Health Literacy Intervention Trial
Health Literacy, Adolescent Health
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
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.
Vicky Lamb, MSc principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude in people with Wellbeing and Psychological Distress, run by University of Sheffield at 1 site in United Kingdom.
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 2 inclusion and 5 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 24 May 2022. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 Depression Level (time frame: Pre- to post-intervention (28 days)). 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 24 May 2022.