Advanced CancerNCT03751995
POEM (Practice of Embracing Each Moment) Study (Delivery Science)
A study testing Mindfulness meditation in people with Advanced Cancer and Depression, run by Kaiser Permanente at 1 site in United States.
Trial summary
The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of mHealth two mindfulness interventions as part of standard palliative care support within Kaiser Permanente… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Depression, Anxiety
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 29 Apr 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
- Smartphone or tablet ownership OR has a computer with internet access
- Ability to read and understand English
- Patients: current Kaiser Permanente member with diagnosis of cancer and receiving palliative or supportive therapy at one of the participating oncology clinics
- Caregivers: primary unpaid support person of the patient who takes care of the patient at least two hours a week.
Who cannot join
- Severe hearing impairment
- Severe mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94611
About this study
The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of mHealth two mindfulness interventions as part of standard palliative care support within Kaiser Permanente Northern California.
Read the detailed description
A cancer diagnosis is associated with high levels of distress in both patients and their family caregivers. Although studies have demonstrated that mindfulness-based interventions are effective in reducing distress and anxiety of cancer patients, logistical limitations of currently available mindfulness-based stress reduction training options restrict their potential to benefit patients with advanced cancer and their caregivers. Previous pilot mindfulness studies targeting cancer patients and caregivers have demonstrated preliminary feasibility and acceptability of mHealth mindfulness interventions and preliminary efficacy in reducing depression, anxiety and improving quality of life. The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of two mHealth mindfulness interventions as part of standard palliative care support within KPNC. Using data collected through the mindfulness programs, patient/caregiver surveys, clinician surveys, and EHR data, the study aims are: 1) to assess acceptability and feasibility of incorporating an mHealth mindfulness intervention as part of palliative care and to obtain preliminary efficacy of the intervention on patient-reported outcomes, clinical outcomes, and health care utilization; and 2) to gather qualitative feedback regarding the intervention from the clinicians, patients and caregivers. Participating oncology clinics will be randomized into either intervention or usual care arms. Intervention participants may choose from a 6-week webinar-based mindfulness program or a 6-week self-paced mobile app-based mindfulness program. Controls will receive usual care. Rates of participation, completion and adherence among intervention participants and participant-reported outcomes on distress and quality of life among both arms at baseline, post-intervention and 12 weeks will be collected. The hypothesis is that participants in the intervention arm will experience reductions in depression/anxiety and improvement in immune function and quality of life. Clinician surveys and interviews with intervention participants will also be conducted at the end of the intervention to obtain feedback regarding the intervention.
- Conditions
- Advanced Cancer, Depression, Anxiety
- Being tested
- Mindfulness meditation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Participants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks.
The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life.
eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants from medical centers assigned to the control arm will receive usual care. |
| Intervention | Experimental | Participants from medical centers assigned to the intervention arm will receive access to their choice of a mindfulness app or a webinar-based mindfulness course for 6 weeks. Receives: Behavioral: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Scale
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
Measured: Baseline to 6 weeks
Change in Hospital Anxiety and Depression Scale
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
Measured: Baseline to 12 weeks
Secondary outcomes (18)
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care. It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness. Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores. The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale. Higher scores indicate better quality of life.
Measured: Baseline to 6 weeks
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care. It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness. Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores. The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale. Higher scores indicate better quality of life.
Measured: Baseline to 12 weeks
Change in Brief COPE coping strategy questionnaire (patients only)
The Brief COPE is a 28-item questionnaire that measures coping strategies. There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy.
Measured: Baseline to 6 weeks
Change in Brief COPE coping strategy questionnaire (patients only)
The Brief COPE is a 28-item questionnaire that measures coping strategies. There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy.
Measured: Baseline to 12 weeks
Change in Post-Traumatic Growth Inventory
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items). Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives. The PTGI is scored by adding all the responses (score range: 0-105). Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)).
Measured: Baseline to 6 weeks
Change in Post-Traumatic Growth Inventory
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items). Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives. The PTGI is scored by adding all the responses (score range: 0-105). Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)).
Measured: Baseline to 12 weeks
Change in Five Facet Mindfulness Questionnaire
The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20. Higher scores indicate greater mindfulness.
Measured: Baseline to 6 weeks
Change in Five Facet Mindfulness Questionnaire
The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20. Higher scores indicate greater mindfulness.
Measured: Baseline to 12 weeks
Change in Caregiver Quality of Life-Cancer scale (caregivers only)
The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life. The overall score is calculated by summing all items, and possible scores range 0-140. Higher scores indicate better quality of life.
Measured: Baseline to 6 weeks
Change in Caregiver Quality of Life-Cancer scale (caregivers only)
The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life. The overall score is calculated by summing all items, and possible scores range 0-140. Higher scores indicate better quality of life.
Measured: Baseline to 12 weeks
Change in PROMIS pain interference scale (caregivers only)
The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days. The pain base score is based on one item and scores range 0-10. The pain interference is calculated by summing the remaining 8 items and scores range 8-40.
Measured: Baseline to 6 weeks
Change in PROMIS pain interference scale (caregivers only)
The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days. The pain base score is based on one item and scores range 0-10. The pain interference is calculated by summing the remaining 8 items and scores range 8-40.
Measured: Baseline to 12 weeks
Change in PROMIS sleep disturbance scale (caregivers only)
The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days. A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance. Possible scores range from 8-40.
Measured: Baseline to 6 weeks
Change in PROMIS sleep disturbance scale (caregivers only)
The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days. A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance. Possible scores range from 8-40.
Measured: Baseline to 12 weeks
Change in Brief Fatigue Inventory (caregivers only)
The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale. A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10). Higher scores on the BFI correspond to greater self-reported levels of fatigue.
Measured: Baseline to 6 weeks
Change in Brief Fatigue Inventory (caregivers only)
The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale. A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10). Higher scores on the BFI correspond to greater self-reported levels of fatigue.
Measured: Baseline to 12 weeks
Change in Distress Thermometer
The National Comprehensive Cancer Network Distress Thermometer assesses current distress level. Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress.
Measured: Baseline to 6 weeks
Change in Distress Thermometer
The National Comprehensive Cancer Network Distress Thermometer assesses current distress level. Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Oct 2018
- Primary completion8 Nov 2018
- Study completion29 Apr 2020
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 Advanced CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot pragmatic cluster randomized trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ai Kubo, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751995
- Sponsor's protocol ID
- CN-18-3183
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Liu R, Greyz-Yusupov N, Avins A. Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers. Psychooncology. 2024 Feb;33(2):e5557. doi: 10.1002/pon.5557. Epub 2020 Oct 5.
PubMed 32979294
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POEM (Practice of Embracing Each Moment) Study (Delivery Science)
- ClinicalTrials.gov ID
- NCT03751995
- Acronym / sponsor ID
- CN-18-3183
- Conditions
- Advanced Cancer, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 23 Nov 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.
The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of mHealth two mindfulness interventions as part of standard palliative care support within Kaiser Permanente Northern California.
Detailed description
A cancer diagnosis is associated with high levels of distress in both patients and their family caregivers. Although studies have demonstrated that mindfulness-based interventions are effective in reducing distress and anxiety of cancer patients, logistical limitations of currently available mindfulness-based stress reduction training options restrict their potential to benefit patients with advanced cancer and their caregivers. Previous pilot mindfulness studies targeting cancer patients and caregivers have demonstrated preliminary feasibility and acceptability of mHealth mindfulness interventions and preliminary efficacy in reducing depression, anxiety and improving quality of life. The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of two mHealth mindfulness interventions as part of standard palliative care support within KPNC. Using data collected through the mindfulness programs, patient/caregiver surveys, clinician surveys, and EHR data, the study aims are: 1) to assess acceptability and feasibility of incorporating an mHealth mindfulness intervention as part of palliative care and to obtain preliminary efficacy of the intervention on patient-reported outcomes, clinical outcomes, and health care utilization; and 2) to gather qualitative feedback regarding the intervention from the clinicians, patients and caregivers. Participating oncology clinics will be randomized into either intervention or usual care arms. Intervention participants may choose from a 6-week webinar-based mindfulness program or a 6-week self-paced mobile app-based mindfulness program. Controls will receive usual care. Rates of participation, completion and adherence among intervention participants and participant-reported outcomes on distress and quality of life among both arms at baseline, post-intervention and 12 weeks will be collected. The hypothesis is that participants in the intervention arm will experience reductions in depression/anxiety and improvement in immune function and quality of life. Clinician surveys and interviews with intervention participants will also be conducted at the end of the intervention to obtain feedback regarding the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot pragmatic cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants from medical centers assigned to the control arm will receive usual care. |
| Intervention | Experimental | Behavioral: Mindfulness meditationParticipants from medical centers assigned to the intervention arm will receive access to their choice of a mindfulness app or a webinar-based mindfulness course for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Smartphone or tablet ownership OR has a computer with internet access
- Ability to read and understand English
- Patients: current Kaiser Permanente member with diagnosis of cancer and receiving palliative or supportive therapy at one of the participating oncology clinics
- Caregivers: primary unpaid support person of the patient who takes care of the patient at least two hours a week.
Key exclusion criteria (2 listed)
- Severe hearing impairment
- Severe mental illness
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 |
|---|---|---|
| Mindfulness meditationParticipants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks. The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life. eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in. | Behavioural | Intervention |
Primary outcome
Change in Hospital Anxiety and Depression Scale
Time frame: Baseline to 6 weeks
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
Change in Hospital Anxiety and Depression Scale
Time frame: Baseline to 12 weeks
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
18 secondary outcomes
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
Time frame: Baseline to 6 weeks
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)
Time frame: Baseline to 12 weeks
Change in Brief COPE coping strategy questionnaire (patients only)
Time frame: Baseline to 6 weeks
Change in Brief COPE coping strategy questionnaire (patients only)
Time frame: Baseline to 12 weeks
Change in Post-Traumatic Growth Inventory
Time frame: Baseline to 6 weeks
Change in Post-Traumatic Growth Inventory
Time frame: Baseline to 12 weeks
Change in Five Facet Mindfulness Questionnaire
Time frame: Baseline to 6 weeks
Change in Five Facet Mindfulness Questionnaire
Time frame: Baseline to 12 weeks
Change in Caregiver Quality of Life-Cancer scale (caregivers only)
Time frame: Baseline to 6 weeks
Change in Caregiver Quality of Life-Cancer scale (caregivers only)
Time frame: Baseline to 12 weeks
Change in PROMIS pain interference scale (caregivers only)
Time frame: Baseline to 6 weeks
Change in PROMIS pain interference scale (caregivers only)
Time frame: Baseline to 12 weeks
Change in PROMIS sleep disturbance scale (caregivers only)
Time frame: Baseline to 6 weeks
Change in PROMIS sleep disturbance scale (caregivers only)
Time frame: Baseline to 12 weeks
Change in Brief Fatigue Inventory (caregivers only)
Time frame: Baseline to 6 weeks
Change in Brief Fatigue Inventory (caregivers only)
Time frame: Baseline to 12 weeks
Change in Distress Thermometer
Time frame: Baseline to 6 weeks
Change in Distress Thermometer
Time frame: Baseline to 12 weeks
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 15 Jan 2021.
- Derived from this study: PubMed 32979294Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Liu R, Greyz-Yusupov N, Avins A. Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers. Psychooncology. 2024 Feb;33(2):e5557. doi: 10.1002/pon.5557. Epub 2020 Oct 5.
- Individual participant dataSharing planned: No
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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.
Ai Kubo, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Advanced Cancer and Depression, run by Kaiser Permanente at 1 site in United States.
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 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 15 Jan 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 United States. 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 Hospital Anxiety and Depression Scale (time frame: Baseline to 6 weeks). 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 NCT03751995, 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 15 Jan 2021.