SuicideMBCT-SNCT01872338
Mindfulness-Based Cognitive Therapy for Suicide Prevention
A study testing Mindfulness-Based Cognitive Therapy for Suicide and Treatment as usual in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Mindfulness-Based Cognitive Therapy for Suicide and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2013to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The following criteria were formulated to recruit a sample at high risk for suicide behavior.
- The subject has experienced a suicidal event during the past 30 days. A suicidal event involves
- 1) psychiatric hospitalization due to suicidal risk,
- 2) psychiatric hospitalization if subject was already on the High Risk for Suicide List,
- 3) suicidal ideation with suicidal intent,
- 4) suicidal preparatory behaviors, or
Show all 11Show fewer
- 5) actual, interrupted, or aborted suicide attempt.
- AND
- The subject is on or will be placed on the VA High Risk for Suicide List
- OR The subject had an actual, interrupted, or aborted attempt in the last year
- OR In the study clinician's opinion (i.e., Masters or Doctoral level study personnel with formal mental health training) in consultation with the PI, the suicidal event is significant enough to warrant treatment to reduce suicidal risk.
Who cannot join
- cognitive deficits that decrease the likelihood of benefit from MBCT-S
- severe symptoms of hallucinations or delusions
- disorganized or disruptive behaviors
- medically unstable
- current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
Lyons, New Jersey, 07939
About this study
Official title: Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans
The purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans.
Read the detailed description
Every month the VA becomes aware of approximately 1,100 Veterans in VA care who attempt suicide. While the VA has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. Primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, Mindfulness-Based Cognitive Therapy (MBCT), for Veterans on the VA's High Risk for Suicide List. The investigators' adapted version of MBCT for suicide (MBCT-S) integrates mindfulness meditation techniques with the VA Safety Plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. This study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal Veterans for whom evidence-based therapies are severely limited.
- Conditions
- Suicide
- Being tested
- Mindfulness-Based Cognitive Therapy for Suicide, Treatment as usual
- Keywords
- suicide prevention, mindfulness-based cognitive therapy, mindfulness meditation, Veterans, safety planning
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy for SuicideBehavioural
Also called MBCT-S
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
Treatment as usualBehavioural
VA standard care for suicide prevention
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Active comparator | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Receives: Behavioral: Mindfulness-Based Cognitive Therapy for Suicide |
| Treatment As Usual | Other | VA standard care for suicide prevention Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Event
The investigators define "event" broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization.
Measured: 12-months post-baseline
Secondary outcomes (3)
Suicide Attempt
Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent
Measured: 12 months post-baseline
Suicidal Ideation
clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.
Measured: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Hopelessness
Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.
Measured: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start1 Dec 2013
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Columbia University, Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Alejandro Interian, PhD, Principal investigator, Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872338
- Sponsor's protocol ID
- IIR 12-134
- Acronym
- MBCT-S
- Status last verified
- Apr 2020
- First submitted
- 10 May 2013
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Interian A, Miller R, Dave C, Latorre M, St Hill L, King A, Boschulte DR, Kline A, Siegel D, Sedita MM, Chesin MS. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness (N Y). 2024 Jun 18;15:1701-1712.
PubMed 40134457Interian A, Chesin MS, Stanley B, Latorre M, St Hill LM, Miller RB, King AR, Boschulte DR, Rodriguez KM, Kline A. Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13791. doi: 10.4088/JCP.20m13791.
PubMed 34464524
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans
- ClinicalTrials.gov ID
- NCT01872338
- Acronym / sponsor ID
- MBCT-S / IIR 12-134
- Conditions
- Suicide
- Keywords
- suicide prevention, mindfulness-based cognitive therapy, mindfulness meditation, Veterans, safety planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Columbia University, Rutgers, The State University of New Jersey
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 22 Apr 2020
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 test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans.
Detailed description
Every month the VA becomes aware of approximately 1,100 Veterans in VA care who attempt suicide. While the VA has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. Primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, Mindfulness-Based Cognitive Therapy (MBCT), for Veterans on the VA's High Risk for Suicide List. The investigators' adapted version of MBCT for suicide (MBCT-S) integrates mindfulness meditation techniques with the VA Safety Plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. This study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal Veterans for whom evidence-based therapies are severely limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Active comparator | Behavioral: Mindfulness-Based Cognitive Therapy for SuicidePsychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
| Treatment As Usual | Other | Behavioral: Treatment as usualVA standard care for suicide prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The following criteria were formulated to recruit a sample at high risk for suicide behavior.
- The subject has experienced a suicidal event during the past 30 days. A suicidal event involves
- AND
- The subject is on or will be placed on the VA High Risk for Suicide List
Key exclusion criteria (5 listed)
- cognitive deficits that decrease the likelihood of benefit from MBCT-S
- severe symptoms of hallucinations or delusions
- disorganized or disruptive behaviors
- medically unstable
- current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months
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 Therapy for SuicideAlso: MBCT-SPsychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. | Behavioural | Mindfulness-Based Cognitive Therapy + Treatment As Usual |
| Treatment as usualVA standard care for suicide prevention | Behavioural | Treatment As Usual |
Primary outcome
Suicide Event
Time frame: 12-months post-baseline
The investigators define "event" broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization.
3 secondary outcomes
Suicide Attempt
Time frame: 12 months post-baseline
Suicidal Ideation
Time frame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Hopelessness
Time frame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40134457Interian A, Miller R, Dave C, Latorre M, St Hill L, King A, Boschulte DR, Kline A, Siegel D, Sedita MM, Chesin MS. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness (N Y). 2024 Jun 18;15:1701-1712.
- Derived from this study: PubMed 34464524Interian A, Chesin MS, Stanley B, Latorre M, St Hill LM, Miller RB, King AR, Boschulte DR, Rodriguez KM, Kline A. Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13791. doi: 10.4088/JCP.20m13791.
- Individual participant dataSharing planned: No
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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.
Alejandro Interian, PhD principal investigator
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy for Suicide and Treatment as usual in people with Suicide, run by VA Office of Research and Development at 2 sites 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 11 inclusion and 5 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Suicide Event (time frame: 12-months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872338, which also lists 2 linked publications.
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 5 May 2020.