Clinical trial NCT02987426: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psychiatric Disorders
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mindfulness Intervention
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Brief Psychiatric Rating Scale score
timeFrame: 1-week follow-up
Secondary outcomes:
measure: Inpatient Psychiatric length of stay (days)
timeFrame: Within 12 months
Other outcomes:
measure: Insomnia with Athens scale
timeFrame: At admission to the psychiatry unit and at 1-week follow-up
measure: Quality of life assessed with Euro-QOL scale
timeFrame: At admission to the psychiatry unit and at 1-week follow-up
measure: Psychotropic medication and "as needed" PRN medication use
timeFrame: At admission to the psychiatry unit and at 1-week follow-up
measure: Likert Scale
timeFrame: At 1-week follow-up
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: