search
Back to results

Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms

Primary Purpose

Anxiety, Depression, Mood

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Abbreviated-Mindfulness-based Therapy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Mindfulness-based Therapy, Wellbeing, Treatment

Eligibility Criteria

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

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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abbreviated Mindfulness-based Therapy

Arm Description

5 week, abbreviated group MBT treatment for depression and anxiety

Outcomes

Primary Outcome Measures

Change from Baseline Depressive Symptoms at 5 Week
Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)
Change from Baseline Anxiety Symptoms at 5 Week
Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)

Secondary Outcome Measures

Change from Baseline Mental Wellbeing at 5 Week
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Change from Baseline Self-Compassion at 5 Week
Scale used to measure Self-Compassion: Self-Compassion Scale Short-Form (SCS-SF)

Full Information

First Posted
September 22, 2017
Last Updated
December 12, 2018
Sponsor
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT03293797
Brief Title
Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms
Official Title
Improving Access to Quality Mental Healthcare Through Innovations in Psychotherapy: A Pilot Study of a Novel, Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

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
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. A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility / efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of this controlled study is to further test feasibility and acceptability of this intervention to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to accessing mental health care.
Detailed Description
BACKGROUND: ABBREVIATED-MINDFULNESS BASED THERAPY (A-MBT) 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 waittime 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 depressive / anxious symptoms and stress, while improve quality of life and mental wellbeing among mood and anxiety outpatients referred to the Mindfulness-Based Therapy Clinic at Sunnybrook Health Sciences Centre. Hypothesis/Research Question The study hypothesis is that an abbreviated MBT for mood / anxiety outpatient populations will show improvement in self-reported measures of clinical primary (Depression, Anxiety) and secondary (well-being, stress, self-compassion) outcomes and will be feasible for the population. Feasibility will be determined by patient program adherence (70% of participants attend ≥75% of sessions) and effect size (moderate magnitude of change in PHQ-9 / GAD-7), Cohen's d = ≥0.5). The effect size will provide a measure of how practically and clinically significant the treatment effect is, by measuring change in baseline, pre-treatment, post-treatment, 1/3/6 month and 1 year follow-up mean scores for the outcome measures. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Mood
Keywords
Mindfulness-based Therapy, Wellbeing, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abbreviated Mindfulness-based Therapy
Arm Type
Experimental
Arm Description
5 week, abbreviated group MBT treatment for depression and anxiety
Intervention Type
Behavioral
Intervention Name(s)
Abbreviated-Mindfulness-based Therapy
Other Intervention Name(s)
A-MBT
Intervention Description
A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
Primary Outcome Measure Information:
Title
Change from Baseline Depressive Symptoms at 5 Week
Description
Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)
Time Frame
Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Title
Change from Baseline Anxiety Symptoms at 5 Week
Description
Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame
Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Secondary Outcome Measure Information:
Title
Change from Baseline Mental Wellbeing at 5 Week
Description
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame
Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Title
Change from Baseline Self-Compassion at 5 Week
Description
Scale used to measure Self-Compassion: Self-Compassion Scale Short-Form (SCS-SF)
Time Frame
Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Diplock, BSc MAc
Phone
416-480-6100
Ext
81233
Email
ben.diplock@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Selchen, MD MSt FRCPC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Selchen, MD MSt FRCPC
Organizational Affiliation
Sunnybrook Healthy Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Diplock, BSc
Phone
416-480-6100
Ext
81233
Email
ben.diplock@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms

We'll reach out to this number within 24 hrs