CClinicalTrials.gg
CompletedNCT02987426Updated Sep 16, 2020

Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?

A Phase 2/3 interventional study of Mindfulness-oriented intervention in Psychiatric Disorders, sponsored by Lady Davis Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Lady Davis Institute · Phase 2/3, Interventional, and Supportive care

Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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". 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.

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.

02

Conditions studied

  • Psychiatric Disorders
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 20 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Lady Davis Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Acute high risk to self and others - defined by being hospitalized in the confined (locked) unit (High Care or UTT at JGH).
  2. 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Mindfulness-oriented intervention

    Patients will get a mindfulness-oriented intervention daily for 10 minutes.

    Behavioral: Mindfulness-oriented intervention

  • No intervention
    Treatment as Usual

    This group will continue receiving their normal inpatient psychiatric care and receive information (paper brochures) about health promotion.

Interventions

  • BehavioralMindfulness-oriented intervention

    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

06

What researchers measure

Primary outcomes

  1. Change in Brief Psychiatric Rating Scale score

    Time frame: 1-week follow-up

Secondary outcomes

  1. Inpatient Psychiatric length of stay (days)

    Time frame: Within 12 months

Other outcomes

  1. Insomnia with Athens scale

    Time frame: At admission to the psychiatry unit and at 1-week follow-up

  2. Quality of life assessed with Euro-QOL scale

    Time frame: At admission to the psychiatry unit and at 1-week follow-up

  3. Psychotropic medication and "as needed" PRN medication use

    Time frame: At admission to the psychiatry unit and at 1-week follow-up

  4. Likert Scale

    The patient's satisfaction will be assessed with a 10 point Likerts scale

    Time frame: At 1-week follow-up

07

Study locations

1 site
  • Jewish General Hospital
    Montréal, Quebec H3T 1E2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02987426
Lead sponsor
Lady Davis Institute
Responsible party
Dr. Karl Looper (Psychiatrist-in-Chief, Jewish General Hospital Associate Professor, Department of Psychiatry, McGill University, Lady Davis Institute) — Principal investigator
First posted
Dec 9, 2016
Start date
May 19, 2017
Primary completion
Feb 1, 2020
Completion
Feb 1, 2020
Last update
Sep 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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