Monopolar Depression, Single Episode or UnspecifiedPhase 1NCT01826240
Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior
A Phase 1 study testing MBCT+SPI in people with Monopolar Depression, Single Episode or Unspecified and Suicidal and Self-injurious Behaviour, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT) + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine its feasibility, acceptability, safety and preliminary effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Monopolar Depression, Single Episode or Unspecified, Suicidal and Self-injurious Behaviour
- What is being tested?
- MBCT+SPI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2015
- Phase
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65
- History of depression
- Suicidal behavior or thoughts (i.e., current suicidal thoughts at screening and history of at least one suicide attempt or suicide-related behavior (aborted or interrupted suicide attempt) or suicidal ideation with plan or method in the past 6 months)
- In active treatment (e.g., receiving psychiatric medications)
Who cannot join
- Current mania, psychosis, Obsessive-Compulsive Disorder, Traumatic Brain Damage, Organic or Acute Brain Syndrome, Mental Retardation or pervasive developmental disorder
- Requires priority treatment for an acute illness or debilitating problem such as severe primary substance dependence or anorexia nervosa
- Inability to complete psychiatric interview or group treatment due to lack of cooperation or lack of comprehension.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior: A Treatment Development Study
The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT) + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is to collect data on the cognitive changes underlying treatment gains.
Read the detailed description
- The study is a nine-week clinical trial combining Safety Planning Intervention plus Mindfulness-Based Cognitive Therapy for patients with a recent history of suicidal thoughts or behavior and current or past depressive symptoms.
- These treatments work for depression and some preliminary data suggest they may work to prevent suicidal behavior.
- Participation includes:
- Nine weeks of free treatment
- Clinical assessments
- An opportunity to offer your views on treatment and suggestions for improving the treatment in focus groups
- Conditions
- Monopolar Depression, Single Episode or Unspecified, Suicidal and Self-injurious Behaviour
- Being tested
- MBCT+SPI
- Medical subject headings
- Depression, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT+SPIBehavioural
Also called Mindfulness-Based Cognitive Therapy, Safety Planning Intervention
Safety Planning Intervention (SPI), a very brief intervention focused on identifying personalized coping strategies to manage acute suicidality, is combined with Mindfulness-Based Cognitive Therapy (MBCT), a group intervention comprised of mindfulness training and cognitive therapy techniques. Treatment lasts 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MBCT+SPI | Experimental | Note: There is only one condition in this study. Mindfulness-Based Cognitive Therapy (MBCT) is combined with Safety Planning Intervention (SPI). All individuals who choose to participate will receive MBCT+SPI. Receives: Behavioral: MBCT+SPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Feasibility
Measured: participants will be followed for the duration of treatment, an expected average of 9 weeks
Consumer Satisfaction Questionnaire
Acceptability
Measured: post-treatment (at 9 weeks)
Change in scores on Scale for Suicide Ideation
Safety
Measured: participants will be followed for the duration of treatment, an expected average of 9 weeks
Secondary outcomes (1)
Change in scores on Beck Depression Inventory (BDI-II)
Effectiveness
Measured: baseline and post-treatment (at 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monopolar Depression, Single Episode or UnspecifiedStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Megan Chesin, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826240
- Sponsor's protocol ID
- 6592
- Other IDs
- PDF-0-076-11
- Status last verified
- Apr 2013
- First submitted
- 13 Mar 2013
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior: A Treatment Development Study
- ClinicalTrials.gov ID
- NCT01826240
- Acronym / sponsor ID
- 6592
- Conditions
- Monopolar Depression, Single Episode or Unspecified, Suicidal and Self-injurious Behaviour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2013 (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.
The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT) + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is to collect data on the cognitive changes underlying treatment gains.
Detailed description
- The study is a nine-week clinical trial combining Safety Planning Intervention plus Mindfulness-Based Cognitive Therapy for patients with a recent history of suicidal thoughts or behavior and current or past depressive symptoms.
- These treatments work for depression and some preliminary data suggest they may work to prevent suicidal behavior.
- Participation includes:
- Nine weeks of free treatment
- Clinical assessments
- An opportunity to offer your views on treatment and suggestions for improving the treatment in focus groups
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT+SPI | Experimental | Behavioral: MBCT+SPINote: There is only one condition in this study. Mindfulness-Based Cognitive Therapy (MBCT) is combined with Safety Planning Intervention (SPI). All individuals who choose to participate will receive MBCT+SPI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65
- History of depression
- Suicidal behavior or thoughts (i.e., current suicidal thoughts at screening and history of at least one suicide attempt or suicide-related behavior (aborted or interrupted suicide attempt) or suicidal ideation with plan or method in the past 6 months)
- In active treatment (e.g., receiving psychiatric medications)
Key exclusion criteria (3 listed)
- Current mania, psychosis, Obsessive-Compulsive Disorder, Traumatic Brain Damage, Organic or Acute Brain Syndrome, Mental Retardation or pervasive developmental disorder
- Requires priority treatment for an acute illness or debilitating problem such as severe primary substance dependence or anorexia nervosa
- Inability to complete psychiatric interview or group treatment due to lack of cooperation or lack of comprehension.
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 |
|---|---|---|
| MBCT+SPIAlso: Mindfulness-Based Cognitive Therapy, Safety Planning InterventionSafety Planning Intervention (SPI), a very brief intervention focused on identifying personalized coping strategies to manage acute suicidality, is combined with Mindfulness-Based Cognitive Therapy (MBCT), a group intervention comprised of mindfulness training and cognitive therapy techniques. Treatment lasts 9 weeks. | Behavioural | MBCT+SPI |
Primary outcome
Retention
Time frame: participants will be followed for the duration of treatment, an expected average of 9 weeks
Feasibility
Consumer Satisfaction Questionnaire
Time frame: post-treatment (at 9 weeks)
Acceptability
Change in scores on Scale for Suicide Ideation
Time frame: participants will be followed for the duration of treatment, an expected average of 9 weeks
Safety
1 secondary outcome
Change in scores on Beck Depression Inventory (BDI-II)
Time frame: baseline and post-treatment (at 9 weeks)
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 4 Dec 2015.
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.
Megan Chesin, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBCT+SPI in people with Monopolar Depression, Single Episode or Unspecified and Suicidal and Self-injurious Behaviour, run by New York State Psychiatric Institute at 1 site in United States.
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 3 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 4 Dec 2015. 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 United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Retention (time frame: participants will be followed for the duration of treatment, an expected average of 9 weeks). The study lists 3 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 4 Dec 2015.