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Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?

Primary Purpose

Psychiatric Disorders

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-oriented intervention
Sponsored by
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychiatric Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-oriented intervention

Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Brief Psychiatric Rating Scale score

Secondary Outcome Measures

Inpatient Psychiatric length of stay (days)

Full Information

First Posted
April 26, 2016
Last Updated
September 11, 2020
Sponsor
Lady Davis Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02987426
Brief Title
Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?
Official Title
Can Brief Mindfulness-oriented Interventions Improve Psychiatric Symptoms and Shorten Psychiatric Hospitalizations? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Mindfulness Intervention
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-oriented intervention
Arm Type
Experimental
Arm Description
Patients will get a mindfulness-oriented intervention daily for 10 minutes.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
This group will continue receiving their normal inpatient psychiatric care and receive information (paper brochures) about health promotion.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-oriented intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Brief Psychiatric Rating Scale score
Time Frame
1-week follow-up
Secondary Outcome Measure Information:
Title
Inpatient Psychiatric length of stay (days)
Time Frame
Within 12 months
Other Pre-specified Outcome Measures:
Title
Insomnia with Athens scale
Time Frame
At admission to the psychiatry unit and at 1-week follow-up
Title
Quality of life assessed with Euro-QOL scale
Time Frame
At admission to the psychiatry unit and at 1-week follow-up
Title
Psychotropic medication and "as needed" PRN medication use
Time Frame
At admission to the psychiatry unit and at 1-week follow-up
Title
Likert Scale
Description
The patient's satisfaction will be assessed with a 10 point Likerts scale
Time Frame
At 1-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and above Admitted to the Open Unit of Jewish General Hospital Psychiatric Inpatient Unit Exclusion Criteria: 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.
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?

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