NCT02861066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

August 5, 2016

Last Update Submit

September 19, 2018

Conditions

Keywords

Mindfulness-based InterventionWellbeingTreatment

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Depressive Symptoms at 6 Weeks

    Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)

    Pre- (Week 0) and Post-Treatment Assessment (Week 6)

  • Change from Baseline Anxiety Symptoms at 6 Weeks

    Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7 (GAD-7).

    Pre- (Week 0) and Post-Treatment Assessment (Week 6)

Secondary Outcomes (2)

  • Change from Baseline Anxiety Symptoms at 6 Weeks

    Pre- (Week 0) and Post-Treatment Assessment (Week 6)

  • Change from Baseline Mental Wellbeing at 6 Weeks

    Pre- (Week 0) and Post-Treatment Assessment (Week 6)

Study Arms (1)

Mindfulness-based Intervention

EXPERIMENTAL

6 week, abbreviated group MBI treatment for depression and anxiety

Behavioral: Mindfulness-based Intervention

Interventions

MBI will be delivered in group format, 120 minutes per week, for 6 consecutive weeks with 10-20 participants per group.

Also known as: MBI
Mindfulness-based Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Steven Selchen, MD MSt FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 20, 2018

Record last verified: 2017-09