Depression, AnxietyEarly Phase 1NCT02954250
Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide
A Early Phase 1 study testing Mindfulness Based Cognitive Therapy in people with Depression, Anxiety, run by Lady Davis Institute at 1 site in Canada.
Trial summary
Background: According to the World Health Organization, one million people die by suicide each year worldwide and the rate of attempted suicide is ten times greater. A less known fact is that suicide is 3 times more frequent in elderly adults compared to younger counterpart. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Dec 2017
- Phase
- Early Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current major depressive episode, major depressive disorder (DSM-V) as per the HAM-D-21 ≥ 10;
- With no recent psychotropic modifications;
- History of suicidal ideation and/or personal history of suicide attempt;
- Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test).
Who cannot join
- Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)[48]
- Acute psychotic symptoms
- Acute Suicidal intent (within 48-72 hours)
- Hearing impairment not improved with hearing aids and/or sound amplification
- Unable to engage in a group meditation for physical or practical reasons
- Ongoing Active Psychotherapy (e.g. a course of CBT psychotherapy)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H1R3
About this study
Official title: Modified Mindfulness Based Cognitive Therapy for the Treatment of Depressive Symptoms and Cognitive Inhibition in Patients at Risk for Suicide: A Pilot Randomized Controlled Trial
Background: According to the World Health Organization, one million people die by suicide each year worldwide and the rate of attempted suicide is ten times greater. A less known fact is that suicide is 3 times more frequent in elderly adults compared to younger counterpart. Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly in particular, remain difficult. Clinical, biological and genetic data suggests that SB may be best understood according to a stress-vulnerability model where, more vulnerable individuals are at increased risk of committing a suicidal act when experiencing (mostly social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.
Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many psychiatric symptoms in many different populations, given that this therapy reduces cognitive creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified Mindfulness Based Cognitive Therapy (MMBCT).
Read more
Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people with SB, but also, effective to treat depressive symptoms and suicidal ideation. Additionally, we will explore the changes in cognitive testing.
Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The primary outcomes will examine feasibility and acceptability of the treatment. The secondary outcome measures will scores in HAM-D and we will control for any important covariates differing between groups, (e.g. age, sex, # medical illnesses).
Perspectives: Implementation of these interventions could potentially prevent many consultations to psychiatry/mental health professionals. Increase quality of life, decrease medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging population, this could translate to substantial savings in health costs.
- Conditions
- Depression, Anxiety
- Being tested
- Mindfulness Based Cognitive Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
The 8-week MMBCT protocol combines the practice of specific meditation techniques with cognitive therapy principles applicable to anxiety and depression. Each session will cover a meditation practice, as well as a relevant topic for discussion. The initial sessions will introduce general concepts of mindfulness (non-judgemental awareness, being in the moment, fostering curiosity, etc.), which will be expanded to more elaborate notions that are particularly relevant to anxiety, depression and suicidal ideations (recognizing thoughts are not facts, cultivating loving kindness for oneself, improving communication with others, etc.) Participants will be encouraged to practice the mindfulness techniques between sessions, a process that will be reviewed during groups in an ongoing fashion.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients randomized to the control group will be offered literature on mental health promotion and Treatment as usual |
| Mindfulness Group | Experimental | The intervention will consist of group, lasting 90 minutes in one session per week for 8 weeks. The exercises will be 5 minutes long alternating between 4 or 5 each session. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fulfillment of initial recruitment goals (first 20 patients)
Measured: within 12 months
Secondary outcomes (2)
Decreases in HAM-D Scale
Measured: over 8-weeks period
Improvement in the Stroop task performances
Measured: over 8-weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karl Looper, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954250
- Sponsor's protocol ID
- IUSMD-16-17
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Mindfulness Based Cognitive Therapy for the Treatment of Depressive Symptoms and Cognitive Inhibition in Patients at Risk for Suicide: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02954250
- Acronym / sponsor ID
- IUSMD-16-17
- Conditions
- Depression, Anxiety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Nov 2016 (estimated)
- 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.
Background: According to the World Health Organization, one million people die by suicide each year worldwide and the rate of attempted suicide is ten times greater. A less known fact is that suicide is 3 times more frequent in elderly adults compared to younger counterpart. Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly in particular, remain difficult. Clinical, biological and genetic data suggests that SB may be best understood according to a stress-vulnerability model where, more vulnerable individuals are at increased risk of committing a suicidal act when experiencing (mostly social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.
Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many psychiatric symptoms in many different populations, given that this therapy reduces cognitive creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified Mindfulness Based Cognitive Therapy (MMBCT).
Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people with SB, but also, effective to treat depressive symptoms and suicidal ideation. Additionally, we will explore the changes in cognitive testing.
Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The primary outcomes will examine feasibility and acceptability of the treatment. The secondary outcome measures will scores in HAM-D and we will control for any important covariates differing between groups, (e.g. age, sex, # medical illnesses).
Perspectives: Implementation of these interventions could potentially prevent many consultations to psychiatry/mental health professionals. Increase quality of life, decrease medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging population, this could translate to substantial savings in health costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients randomized to the control group will be offered literature on mental health promotion and Treatment as usual |
| Mindfulness Group | Experimental | Behavioral: Mindfulness Based Cognitive TherapyThe intervention will consist of group, lasting 90 minutes in one session per week for 8 weeks. The exercises will be 5 minutes long alternating between 4 or 5 each session. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current major depressive episode, major depressive disorder (DSM-V) as per the HAM-D-21 ≥ 10;
- With no recent psychotropic modifications;
- History of suicidal ideation and/or personal history of suicide attempt;
- Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test).
Key exclusion criteria (6 listed)
- Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)[48]
- Acute psychotic symptoms
- Acute Suicidal intent (within 48-72 hours)
- Hearing impairment not improved with hearing aids and/or sound amplification
- Unable to engage in a group meditation for physical or practical reasons
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 |
|---|---|---|
| Mindfulness Based Cognitive TherapyThe 8-week MMBCT protocol combines the practice of specific meditation techniques with cognitive therapy principles applicable to anxiety and depression. Each session will cover a meditation practice, as well as a relevant topic for discussion. The initial sessions will introduce general concepts of mindfulness (non-judgemental awareness, being in the moment, fostering curiosity, etc.), which will be expanded to more elaborate notions that are particularly relevant to anxiety, depression and suicidal ideations (recognizing thoughts are not facts, cultivating loving kindness for oneself, improving communication with others, etc.) Participants will be encouraged to practice the mindfulness techniques between sessions, a process that will be reviewed during groups in an ongoing fashion. | Behavioural | Mindfulness Group |
Primary outcome
Fulfillment of initial recruitment goals (first 20 patients)
Time frame: within 12 months
2 secondary outcomes
Decreases in HAM-D Scale
Time frame: over 8-weeks period
Improvement in the Stroop task performances
Time frame: over 8-weeks period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Related trials for Depression, Anxiety
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mindfulness Based Cognitive Therapy in people with Depression, Anxiety, run by Lady Davis Institute 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Sep 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fulfillment of initial recruitment goals (first 20 patients) (time frame: within 12 months). 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 10 Sep 2020.