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Psychiatric DisordersPhase 2/3NCT02987426

Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?

A Phase 2/3 study testing Mindfulness-oriented intervention in people with Psychiatric Disorders, run by Lady Davis Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mindfulness-based interventions have gained increasing popularity in recent years as effective treatment for mental illness. Mindfulness is defined as paying attention in a particular way: on purpose, in the present moment, and non-judgmentally: "Being", rather than "Doing". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychiatric Disorders
What is being tested?
Mindfulness-oriented intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
19 May 2017to 1 Feb 2020
Phase
Phase 2/3
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

  • Age 18 years and above
  • Admitted to the Open Unit of Jewish General Hospital Psychiatric Inpatient Unit

Who cannot join

  • Acute high risk to self and others - defined by being hospitalized in the confined (locked) unit (High Care or UTT at JGH).
  • Have been diagnosed by their psychiatrist with a diagnosis of moderate-to-severe dementia that would interfere with their ability to complete self-reported questionnaires.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: Can Brief Mindfulness-oriented Interventions Improve Psychiatric Symptoms and Shorten Psychiatric Hospitalizations? A Randomized Controlled Trial

Mindfulness-based interventions have gained increasing popularity in recent years as effective treatment for mental illness. Mindfulness is defined as paying attention in a particular way: on purpose, in the present moment, and non-judgmentally: "Being", rather than "Doing". Such mental states can improve emotional regulation through frontal cortex inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction, have been highly effective in a broad range of psychiatric disorders.

Mindfulness-oriented interventions, are potentially useful in acute psychiatric hospitalizations, since they can be delivered as group therapies and are be both cost-effective and scalable. However, such interventions have rarely been provided to patients during psychiatric hospitalizations, where patients are treated for a variety of psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly, MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar disorder, severe anxiety, substance use disorders, and major depressive disorder.

Read more

Few studies have examined mindfulness-oriented treatments in inpatient settings, including two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10) . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in inpatient settings were feasible, although these needed to be brief interventions, given the risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental illness.

A cross-sectional study conducted by our team (n=40) demonstrated that brief group mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported improvements in general well-being and mood after a single 10-minute session. Having been recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75% of inpatients) did not affect patients' capacity to tolerate and benefit from the intervention. In this inpatient psychiatric population, we found that mindfulness-oriented interventions that were brief and involved physical movement (e.g. seated Tai Chi) were better enjoyed compared to other interventions.

Despite the growing literature in this field, data is needed on the effectiveness and health service implications of brief group mindfulness-oriented interventions in inpatient psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to methodological flaws, including inadequate control groups, very small sample sizes (often n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus, if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom severity and shortening psychiatric hospitalizations, this could lead to significant cost-savings.

Being tested
Mindfulness-oriented intervention
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-oriented interventionBehavioural

    The 10 minutes daily sessions every weekday, will take place at the inpatient unit in groups of 10 people. The intervention will be alternating between three forms of "moving" mindfulness-oriented interventions as detailed below:

    Seated Tai Chi: patients will slowly move their arms in soft movements coordinated with slow breaths Gentle stretching: patients will slowly stretch their bodies coordinated with the breath and with awareness of physical sensations throughout the body4 Walking meditation: patients will walk slowly in no particular direction, focusing close attention on the act of walking

Study groups in NCT02987426
Study groupRoleWhat they receive
Mindfulness-oriented interventionExperimentalPatients will get a mindfulness-oriented intervention daily for 10 minutes.
Receives: Behavioral: Mindfulness-oriented intervention
Treatment as UsualNo interventionThis group will continue receiving their normal inpatient psychiatric care and receive information (paper brochures) about health promotion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Psychiatric Rating Scale score

    Measured: 1-week follow-up

Secondary outcomes (1)
  1. Inpatient Psychiatric length of stay (days)

    Measured: Within 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study start19 May 2017
  3. Primary completion1 Feb 2020
  4. Study completion1 Feb 2020

Resources

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 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mindfulness Intervention
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987426
Sponsor's protocol ID
16230
Status last verified
Sep 2020
First submitted
26 Apr 2016
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Mindfulness-oriented intervention in people with Psychiatric Disorders, run by Lady Davis Institute 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 2 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Brief Psychiatric Rating Scale score (time frame: 1-week follow-up). 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 16 Sep 2020; AzTrials last refreshed its copy on 3 Nov 2026.

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