AnxietyNCT03293797
Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms
A study testing Abbreviated-Mindfulness-based Therapy in people with Anxiety and Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Mood
- What is being tested?
- Abbreviated-Mindfulness-based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Steven Selchen, MD MSt FRCPC contact
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Benjamin Diplock, BSc, 416-480-6100 ext. 81233, ben.diplock@sunnybrook.ca
About this study
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
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
- Conditions
- Anxiety, Depression, Mood
- Being tested
- Abbreviated-Mindfulness-based Therapy
- Keywords
- Mindfulness-based Therapy, Wellbeing, Treatment
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated-Mindfulness-based TherapyBehavioural
Also called A-MBT
A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated Mindfulness-based Therapy | Experimental | 5 week, abbreviated group MBT treatment for depression and anxiety Receives: Behavioral: Abbreviated-Mindfulness-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depressive Symptoms at 5 Week
Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)
Measured: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Change from Baseline Anxiety Symptoms at 5 Week
Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)
Measured: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Secondary outcomes (2)
Change from Baseline Mental Wellbeing at 5 Week
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Measured: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Change from Baseline Self-Compassion at 5 Week
Scale used to measure Self-Compassion: Self-Compassion Scale Short-Form (SCS-SF)
Measured: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study startDec 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Selchen, MD MSt FRCPC, Principal investigator, Sunnybrook Healthy Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293797
- Sponsor's protocol ID
- 387-2015
- Status last verified
- Dec 2018
- First submitted
- 22 Sep 2017
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03293797
- Acronym / sponsor ID
- 387-2015
- Conditions
- Anxiety, Depression, Mood
- Keywords
- Mindfulness-based Therapy, Wellbeing, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbreviated Mindfulness-based Therapy | Experimental | Behavioral: Abbreviated-Mindfulness-based Therapy5 week, abbreviated group MBT treatment for depression and anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbreviated-Mindfulness-based TherapyAlso: A-MBTA-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group. | Behavioural | Abbreviated Mindfulness-based Therapy |
Primary outcome
Change from Baseline Depressive Symptoms at 5 Week
Time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)
Change from Baseline Anxiety Symptoms at 5 Week
Time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)
2 secondary outcomes
Change from Baseline Mental Wellbeing at 5 Week
Time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
Change from Baseline Self-Compassion at 5 Week
Time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Selchen, MD MSt FRCPC contact
Steven Selchen, MD MSt FRCPC principal investigator
Sunnybrook Healthy Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated-Mindfulness-based Therapy in people with Anxiety and Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Diplock, BSc MAc (416-480-6100 ext. 81233, ben.diplock@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Depressive Symptoms at 5 Week (time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.