ClinicalTrials.gg
Status unknownNCT03293797Updated Dec 14, 2018

Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms

An interventional study of Abbreviated-Mindfulness-based Therapy in Anxiety, Depression and Mood, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-14.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Depression by Sunnybrook Health Sciences Centre — 3 open to participants now, 5 under way, 1 of them phase 3. Depression · Sunnybrook Health Sciences Centre.

Planned enrollment
13th of 16
25 · median 52
Started
2018
with 1 other
No phase
7 of 18
1 open now
Registered
11th of 18
by date

Among the 18 studies in Depression by Sunnybrook Health Sciences Centre, this one is the 13th largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 with no phase, and was the 11th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

3 of the 18 studies in Depression by Sunnybrook Health Sciences Centre are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Depression by Sunnybrook Health Sciences Centre, or all of them as a file.
02

Study 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.

Read the 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

03

Conditions studied

  • Anxiety
  • Depression
  • Mood

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Keywords

  • Mindfulness-based Therapy
  • Wellbeing
  • Treatment
04

In context

Depression Reclassified

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

This study's planned enrollment of 25 is below the median of 81 across 7,066 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Abbreviated Mindfulness-based Therapy

    5 week, abbreviated group MBT treatment for depression and anxiety

    Behavioral: Abbreviated-Mindfulness-based Therapy

Interventions

  • BehavioralAbbreviated-Mindfulness-based Therapy

    A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.

    Also known as: A-MBT

07

What researchers measure

Primary outcomes

  1. Change from Baseline Depressive Symptoms at 5 Week

    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)

  2. Change from Baseline Anxiety Symptoms at 5 Week

    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 outcomes

  1. Change from Baseline Mental Wellbeing at 5 Week

    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)

  2. Change from Baseline Self-Compassion at 5 Week

    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)]

08

Study locations

1 of 1 sites recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
    Recruiting
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2018; primary completion for Jun 2019, 6 months later.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 6 months is below that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2017
First posted
Sep 26, 2017
StartEst.
Dec 2018
Primary completionEst.
Jun 2019
CompletionEst.
Sep 2019
Last update
Dec 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03293797
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Dec 2018 (estimated)
Primary completion
Jun 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Dec 14, 2018

Study contacts

Benjamin Diplock, BSc MAc
Contact
ben.diplock@sunnybrook.ca
416-480-6100 ext. 81233
Steven Selchen, MD MSt FRCPC
Contact
Steven Selchen, MD MSt FRCPC
principal investigator · Sunnybrook Healthy Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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