AnxietyNCT04415528
Emotion-Focused Mindfulness Therapy: A Feasibility Study for Late Life Anxiety
A study testing Emotion-Focused Mindfulness Therapy in people with Anxiety, run by Stacey Hatch at 1 site in Canada.
Trial summary
Canadians 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. In Ontario, 5.6% of adults 65 and older have anxiety, representing over 100,000 people. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Emotion-Focused Mindfulness Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2020to 30 Sep 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants will be community dwelling older adults at least 65 years of age and with have no existing therapeutic alliance with the PI. Inclusion criteria will be a diagnosis or self-report of anxiety. The presence of symptoms of anxiety will be assessed using the Geriatric Anxiety Inventory (GAI) with a cut off score of 10 which indicates the presence of anxiety (Johnco et al., 2015). Participants will be willing to commit to an eight-week program.
Who cannot join
- Exclusion criteria will be beginning or stopping psychotropic medications within the previous six weeks and concurrent participation in any other mindfulness-based group during the study. Participants will not be excluded if they have prior experience with mindfulness. Further exclusion criteria will be a Telephone Montreal Cognitive Assessment (T-MoCA) cut off score of 19 which indicates the possibility of mild cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Canadians 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. In Ontario, 5.6% of adults 65 and older have anxiety, representing over 100,000 people. Eastern Ontario primary care clinics report significantly higher numbers of adults 65 and older diagnosed with anxiety at between 28% and 30%, representing approximately 4,600 people diagnosed with anxiety. Costs to the Canadian health care system of anxiety in community dwelling adults aged 65 and older have been estimated at $61.2 to $119.8 million per 1,000,000 people. These costs can reasonably be expected to increase by 2021 when the percentage of older adults 65+ with mental illness is estimated to be approximately 30% of the older population base.
Anxiety in older adults has been linked retaining new information and the instrumental activities of daily living, sleep disturbance, suicidal ideation particularly among men, and increased use of health care services. Present pharmacological treatments for anxiety in older adults have met with limited success. Mindfulness-based interventions (MBIs) are an area of research interest in the treatment of anxiety. The use of MBIs has shown a trend toward self-reported lower levels of chronic stress and psychological stress among older adults small scale RCTs and qualitative studies.
Emotion focused mindfulness meditation therapy (EFMT) is a MBI that shows promise. EFMT has been demonstrated to reduce symptoms of anxiety in general populations. EFMT's focus on meditation and the felt sense of emotions, rather than learning new material, may make it a promising intervention for reducing symptoms of anxiety for older adults who often report normal aging problems such as general forgetfulness and difficulty with word recall. EFMT may be a potentially promising intervention that has not yet been tested in older adults. EFMT can be offered in primary care, community and hospital settings. Further research is required to determine if EFMT could reduce anxiety for older adults.
Read the detailed description
The purpose of this small scale RCT is to determine the feasibility and acceptability of EFMT among community dwelling older adults who experience anxiety. This study has the following three aims: to determine if participants can be recruited, enrolled, and retained; to determine if participants can adhere to all components of the intervention; and to determine the extent to which participants who receive the intervention have decreased levels of anxiety compared to those who do not receive the intervention. The secondary outcomes will be to determine the extent to which participants who receive the intervention have improved sleep quality, and improved subjective memory functioning compared to those who do not receive the intervention.
This will be a small pilot RCT study that will use a wait list control trial design. Participants will be randomly allocated to either the intervention or control group. Emotion-Focused Mindfulness Therapy (EFMT) is a group intervention consisting of eight weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between twenty and thirty-five minutes, and then participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Following journalling, each participant describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions.
The study will be conducted in an online delivery PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention.
- Conditions
- Anxiety
- Being tested
- Emotion-Focused Mindfulness Therapy
- Keywords
- anxiety, aging and health, adults aged 65 and older, mindfulness based intervention, meditation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused Mindfulness TherapyOther
EFMT is a group intervention of 8weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between 20 and 35 minutes. Participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Each participant then describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions.
The study will be conducted in an online PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will begin receiving the group intervention within one - two weeks of Time 1 assessment. This group will receive Time 2 assessments at the end of the group delivery. Time 3 assessments will be administered eight weeks after the completion of group delivery. Receives: Other: Emotion-Focused Mindfulness Therapy |
| Wait listed control group | Active comparator | The wait listed control group will be assessed at Time 1, eight weeks before receiving the intervention. This group will receive Time 2 assessments at the beginning of their group delivery. This group will complete Time 3 assessments eight weeks after the completion of group delivery. Receives: Other: Emotion-Focused Mindfulness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if participants can be recruited, enrolled, and retained
Data will be gathered and measured on the number of potential participants referred and screened for eligibility, participants meeting eligibility requirements, participants enrolled, and participants completing the intervention. Dates defining the recruitment period will be reported. Number of participants referred by physicians and number of participants who call the PI directly will be combined for each site.
Measured: 8 weeks
Determine if participants can adhere to all components of the intervention
To determine if participants can adhere to the intervention, attendance of 6 / 8 sessions, data on attendance will be gathered. Data for the other measures of adherence of meditation, journaling and reporting will also be gathered. In the tradition of MBI research, the intervention will be considered complete if participants are able to attend a minimum of six of eight meetings (Santorelli, Florence Meleo-Meyer, Koerbel, \& Kabat-Zinn, 2017). Data gathered on adherence to meditation, journaling and reporting aspects of the intervention through weekly reporting forms to be completed by each participant through an online survey. Participants will answer yes or no to whether they engaged in each component. Participants are not required to practice at home, however data will be gathered on the frequency and duration of home practice meditation and journaling to determine if there is a relationship to outcomes.
Measured: From time of enrollment to end of intervention at 8 weeks
Geriatric Anxiety Inventory, to assess change over time
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
Measured: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PQSI) to to assess change over time
The PQSI is a questionnaire validated for use with community dwelling older adults (Carpenter \& Andrykowski, 1998). This measure was selected because sleep complaints are frequently associated with anxiety (C.-M. Yang, Lo, \& Spielman, 2006).The PQSI is a simple 19 item subjective measure of sleep quality and patterns of sleep using a 0 to 3 Likert scale (Smyth, 2008).
Measured: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention
Multifactorial Memory Questionnaire (Troyer & Rich, 2002), to assess change over time
The Multifactorial Memory Questionnaire (MMQ) is a self-assessment scale that measures three aspects of metamemory. Items are scored on a 5-point Likert scale (Troyer \& Smith, 2018).
Measured: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start3 Aug 2020
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a small pilot RCT study that will use a wait list control trial design. Participants will be randomly allocated to either the intervention or control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stacey Hatch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stacey Hatch, Queen's University
- Investigators
- Stacey Hatch, PhDcandidate, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415528
- Sponsor's protocol ID
- 1509
- Status last verified
- Feb 2022
- First submitted
- 27 May 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gayner, B. (2019). Emotion-focused mindfulness therapy. Person-Centered & Experiential Psychotherapies, 1-23. https://doi.org/10.1080/14779757.2019.1572026
Statistics Canada. (2012). Table 13-10-0465-01: Mental health indicators. https://doi.org/https://doi.org/10.25318/1310046501-eng
Wisco, R., & Haber, C. (n.d.). A feasibility study of an emotion focused-mindfulness group. In Press.
Vasiliadis HM, Dionne PA, Preville M, Gentil L, Berbiche D, Latimer E. The excess healthcare costs associated with depression and anxiety in elderly living in the community. Am J Geriatr Psychiatry. 2013 Jun;21(6):536-48. doi: 10.1016/j.jagp.2012.12.016. Epub 2013 Feb 6.
PubMed 23567409Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
PubMed 11773220Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 2007 Feb;19(1):103-14. doi: 10.1017/S1041610206003504.
PubMed 16805925Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.
PubMed 9720850Hatch S, Finlayson M, Rej S, Kessler D. Virtually-Delivered Emotion Focused Mindfulness Therapy (EFMT) Group vs. Wait-List Control for Late-Life Anxiety: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2023 Oct;31(10):767-782. doi: 10.1016/j.jagp.2023.04.007. Epub 2023 Apr 19.
PubMed 37169708Hatch S, Kessler D, Finlayson M, Rej S. Video-delivered emotion-focused mindfulness therapy for late- life anxiety: study protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2021 Sep 3;7(1):169. doi: 10.1186/s40814-021-00905-0.
PubMed 34479632
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion-Focused Mindfulness Therapy: A Feasibility Study for Late Life Anxiety
- ClinicalTrials.gov ID
- NCT04415528
- Acronym / sponsor ID
- 1509
- Conditions
- Anxiety
- Keywords
- anxiety, aging and health, adults aged 65 and older, mindfulness based intervention, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stacey HatchUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 Jun 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.
Canadians 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. In Ontario, 5.6% of adults 65 and older have anxiety, representing over 100,000 people. Eastern Ontario primary care clinics report significantly higher numbers of adults 65 and older diagnosed with anxiety at between 28% and 30%, representing approximately 4,600 people diagnosed with anxiety. Costs to the Canadian health care system of anxiety in community dwelling adults aged 65 and older have been estimated at $61.2 to $119.8 million per 1,000,000 people. These costs can reasonably be expected to increase by 2021 when the percentage of older adults 65+ with mental illness is estimated to be approximately 30% of the older population base.
Anxiety in older adults has been linked retaining new information and the instrumental activities of daily living, sleep disturbance, suicidal ideation particularly among men, and increased use of health care services. Present pharmacological treatments for anxiety in older adults have met with limited success. Mindfulness-based interventions (MBIs) are an area of research interest in the treatment of anxiety. The use of MBIs has shown a trend toward self-reported lower levels of chronic stress and psychological stress among older adults small scale RCTs and qualitative studies.
Emotion focused mindfulness meditation therapy (EFMT) is a MBI that shows promise. EFMT has been demonstrated to reduce symptoms of anxiety in general populations. EFMT's focus on meditation and the felt sense of emotions, rather than learning new material, may make it a promising intervention for reducing symptoms of anxiety for older adults who often report normal aging problems such as general forgetfulness and difficulty with word recall. EFMT may be a potentially promising intervention that has not yet been tested in older adults. EFMT can be offered in primary care, community and hospital settings. Further research is required to determine if EFMT could reduce anxiety for older adults.
Detailed description
The purpose of this small scale RCT is to determine the feasibility and acceptability of EFMT among community dwelling older adults who experience anxiety. This study has the following three aims: to determine if participants can be recruited, enrolled, and retained; to determine if participants can adhere to all components of the intervention; and to determine the extent to which participants who receive the intervention have decreased levels of anxiety compared to those who do not receive the intervention. The secondary outcomes will be to determine the extent to which participants who receive the intervention have improved sleep quality, and improved subjective memory functioning compared to those who do not receive the intervention.
This will be a small pilot RCT study that will use a wait list control trial design. Participants will be randomly allocated to either the intervention or control group. Emotion-Focused Mindfulness Therapy (EFMT) is a group intervention consisting of eight weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between twenty and thirty-five minutes, and then participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Following journalling, each participant describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions.
The study will be conducted in an online delivery PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a small pilot RCT study that will use a wait list control trial design. Participants will be randomly allocated to either the intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Emotion-Focused Mindfulness TherapyThe intervention group will begin receiving the group intervention within one - two weeks of Time 1 assessment. This group will receive Time 2 assessments at the end of the group delivery. Time 3 assessments will be administered eight weeks after the completion of group delivery. |
| Wait listed control group | Active comparator | Other: Emotion-Focused Mindfulness TherapyThe wait listed control group will be assessed at Time 1, eight weeks before receiving the intervention. This group will receive Time 2 assessments at the beginning of their group delivery. This group will complete Time 3 assessments eight weeks after the completion of group delivery. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants will be community dwelling older adults at least 65 years of age and with have no existing therapeutic alliance with the PI. Inclusion criteria will be a diagnosis or self-report of anxiety. The presence of symptoms of anxiety will be assessed using the Geriatric Anxiety Inventory (GAI) with a cut off score of 10 which indicates the presence of anxiety (Johnco et al., 2015). Participants will be willing to commit to an eight-week program.
Key exclusion criteria (1 listed)
- Exclusion criteria will be beginning or stopping psychotropic medications within the previous six weeks and concurrent participation in any other mindfulness-based group during the study. Participants will not be excluded if they have prior experience with mindfulness. Further exclusion criteria will be a Telephone Montreal Cognitive Assessment (T-MoCA) cut off score of 19 which indicates the possibility of mild cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion-Focused Mindfulness TherapyEFMT is a group intervention of 8weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between 20 and 35 minutes. Participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Each participant then describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions. The study will be conducted in an online PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention. | Other | Intervention group, Wait listed control group |
Primary outcome
Determine if participants can be recruited, enrolled, and retained
Time frame: 8 weeks
Data will be gathered and measured on the number of potential participants referred and screened for eligibility, participants meeting eligibility requirements, participants enrolled, and participants completing the intervention. Dates defining the recruitment period will be reported. Number of participants referred by physicians and number of participants who call the PI directly will be combined for each site.
Determine if participants can adhere to all components of the intervention
Time frame: From time of enrollment to end of intervention at 8 weeks
To determine if participants can adhere to the intervention, attendance of 6 / 8 sessions, data on attendance will be gathered. Data for the other measures of adherence of meditation, journaling and reporting will also be gathered. In the tradition of MBI research, the intervention will be considered complete if participants are able to attend a minimum of six of eight meetings (Santorelli, Florence Meleo-Meyer, Koerbel, \& Kabat-Zinn, 2017). Data gathered on adherence to meditation, journaling and reporting aspects of the intervention through weekly reporting forms to be completed by each participant through an online survey. Participants will answer yes or no to whether they engaged in each component. Participants are not required to practice at home, however data will be gathered on the frequency and duration of home practice meditation and journaling to determine if there is a relationship to outcomes.
Geriatric Anxiety Inventory, to assess change over time
Time frame: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PQSI) to to assess change over time
Time frame: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention
Multifactorial Memory Questionnaire (Troyer & Rich, 2002), to assess change over time
Time frame: Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-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 21 Feb 2022.
- BackgroundGayner, B. (2019). Emotion-focused mindfulness therapy. Person-Centered & Experiential Psychotherapies, 1-23. https://doi.org/10.1080/14779757.2019.1572026
- BackgroundStatistics Canada. (2012). Table 13-10-0465-01: Mental health indicators. https://doi.org/https://doi.org/10.25318/1310046501-eng
- BackgroundWisco, R., & Haber, C. (n.d.). A feasibility study of an emotion focused-mindfulness group. In Press.
- Results publication: PubMed 23567409Vasiliadis HM, Dionne PA, Preville M, Gentil L, Berbiche D, Latimer E. The excess healthcare costs associated with depression and anxiety in elderly living in the community. Am J Geriatr Psychiatry. 2013 Jun;21(6):536-48. doi: 10.1016/j.jagp.2012.12.016. Epub 2013 Feb 6.
- Results publication: PubMed 11773220Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
- Results publication: PubMed 16805925Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 2007 Feb;19(1):103-14. doi: 10.1017/S1041610206003504.
- Results publication: PubMed 9720850Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.
- Derived from this study: PubMed 37169708Hatch S, Finlayson M, Rej S, Kessler D. Virtually-Delivered Emotion Focused Mindfulness Therapy (EFMT) Group vs. Wait-List Control for Late-Life Anxiety: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2023 Oct;31(10):767-782. doi: 10.1016/j.jagp.2023.04.007. Epub 2023 Apr 19.
- Derived from this study: PubMed 34479632Hatch S, Kessler D, Finlayson M, Rej S. Video-delivered emotion-focused mindfulness therapy for late- life anxiety: study protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2021 Sep 3;7(1):169. doi: 10.1186/s40814-021-00905-0.
- 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.
Stacey Hatch, PhDcandidate principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused Mindfulness Therapy in people with Anxiety, run by Stacey Hatch 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 1 inclusion and 1 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 21 Feb 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 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?
Determine if participants can be recruited, enrolled, and retained (time frame: 8 weeks). The study lists 3 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 NCT04415528, which also lists 9 linked publications.
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 21 Feb 2022.