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Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms

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ClinicalTrials.gov Identifier: NCT02861066
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Mood Behavioral: Mindfulness-based Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Barriers to Mental Health Care: Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms in a Heterogeneous Clinical Outpatient Group
Study Start Date : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based Intervention
6 week, abbreviated group MBI treatment for depression and anxiety
Behavioral: Mindfulness-based Intervention
MBI will be delivered in group format, 120 minutes per week, for 6 consecutive weeks with 10-20 participants per group.
Other Name: MBI




Primary Outcome Measures :
  1. Change from Baseline Depressive Symptoms at 6 Weeks [ Time Frame: Pre- (Week 0) and Post-Treatment Assessment (Week 6) ]
    Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)

  2. Change from Baseline Anxiety Symptoms at 6 Weeks [ Time Frame: Pre- (Week 0) and Post-Treatment Assessment (Week 6) ]
    Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7 (GAD-7).


Secondary Outcome Measures :
  1. Change from Baseline Anxiety Symptoms at 6 Weeks [ Time Frame: Pre- (Week 0) and Post-Treatment Assessment (Week 6) ]
    Scale used to measure Anxiety Symptoms: Beck Anxiety Inventory (BAI)

  2. Change from Baseline Mental Wellbeing at 6 Weeks [ Time Frame: Pre- (Week 0) and Post-Treatment Assessment (Week 6) ]
    Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861066


Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Steven Selchen, MD MSt FRCPC Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02861066    
Other Study ID Numbers: 387-2105
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2017
Keywords provided by Sunnybrook Health Sciences Centre:
Mindfulness-based Intervention
Wellbeing
Treatment
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms