Clinical trial NCT02861066: Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms
Official title: Reducing Barriers to Mental Health Care: Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms in a Heterogeneous Clinical Outpatient Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Mood
Keywords: Mindfulness-based Intervention
Wellbeing
Treatment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. The goal of this project is to test the effectiveness of an Abbreviated MBT (\<10 hours of clinical time and \<10 hours of homework) in reducing symptoms of depression/anxiety and improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing mental health care.

Detailed description: BACKGROUND: ABBREVIATED-MINDFULNESS BASED INTERVENTION (A-MBI)

By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have strong evidence for improving patient wellness through reduction of anxiety and mood symptoms in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms of time and homework a relevant factor when considering the recent calls for wait time reductions in psychotherapeutic mental health services. These programs take 30+ hours (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60 min./day of meditation homework. The goal of this project is to test the effectiveness of an abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient well-being.

MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. Professional experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop a effective and accessible clinical intervention. This abbreviated MBT has been developed, which if effective will curtail wait-times and increase patient treatment annually.

RATIONAL \& HYPOTHESIS/RESEARCH QUESTION

Rational

Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are highly studied and well-recognized treatment options to reduce anxiety and mood symptoms - demonstrating repeated efficacy in clinical populations. However, the high demands of clinical time and homework are a barrier to many patients. Further, longer clinical interventions mean fewer patients being treated per hour of clinician's time, and therefore longer wait-times. Clinical experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop an effective and more accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it can reduce barriers to mental health care by reaching more patients in a more timely fashion.

The specific objective of this study will be to evaluate a novel and potentially highly effective strategy to reduce symptoms of depression, anxiety and improve quality of life among outpatients in the chosen pilot site, the Odette Cancer Centre.

Hypothesis/Research Question

The overall study hypothesis is that patients participating in an Abbreviated MBT will show improvement in self-reported measures of clinical primary (Depression, Anxiety) and secondary (well-being) outcomes. Improvement will be determined by effect size (magnitude of change ≥0.2) based on the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BDI).

Study Significance

The current pilot study will explore the effects of an Abbreviated-MBT on symptoms of depression and anxiety in an outpatient clinical sample; if effective: a) this would be the first known pilot study to consider and demonstrate efficacy of an Abbreviated-MBT in a clinical outpatient population; b) this treatment could increase the volume of patients treated by up to 3x, reduce wait-times by 2-3 fold, and reach a broader group of patients, including those for whom the investment of time of traditional MBT is too prohibitive.

Eligibility criteria: Inclusion Criteria:

* Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic
* Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, ability to communicate in written and spoken English is an inclusion criterion

Exclusion Criteria:

* Patients who have active or recent (within 3 months) substance abuse/dependence, a history of dementia, untreated posttraumatic stress symptoms, active psychotic or manic symptoms, recent suicide attempt/active suicidality, or current self-injurious behaviour
* Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the last 3 years

Primary outcomes:
measure: Change from Baseline Depressive Symptoms at 6 Weeks
timeFrame: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
measure: Change from Baseline Anxiety Symptoms at 6 Weeks
timeFrame: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Secondary outcomes:
measure: Change from Baseline Anxiety Symptoms at 6 Weeks
timeFrame: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
measure: Change from Baseline Mental Wellbeing at 6 Weeks
timeFrame: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Steven Selchen, MD MSt FRCPC
role: PRINCIPAL_INVESTIGATOR
References: