NCT01872338: MBCT-S

Mindfulness-Based Cognitive Therapy for Suicide Prevention

Completed NA Results posted Last updated 5 May 2020

What this trial tests

NA trial testing Mindfulness-Based Cognitive Therapy for Suicide in Suicide in 135 participants. Completed in 3 April 2019.

Timeline

1 December 2013

Primary endpoint
3 April 2019

3 April 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	135
Start date	1 December 2013
Primary completion	3 April 2019
Estimated completion	3 April 2019
Sites	2 locations across United States

Drugs / interventions tested

• Mindfulness-Based Cognitive Therapy for Suicide
• Treatment as usual

Conditions studied

• Suicide — all drugs for Suicide →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Suicide. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Suicide Event Primary · 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.

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	44
Treatment As Usual	92

Suicide Attempt Secondary · 12 months post-baseline

Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	11
Treatment As Usual	27

Suicidal Ideation Secondary · Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.

Time 1

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	12.4	± 1.2
Treatment As Usual	11.2	± 1.2

Time 2

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	5.8	± 1.2
Treatment As Usual	6.1	± 1.2

Time 3

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	4.8	± 1.1
Treatment As Usual	4.7	± 1.0

Time 4

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	6.1	± 1.1
Treatment As Usual	3.3	± 1.0

Time 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	3.8	± .9
Treatment As Usual	2.3	± .8

Hopelessness Secondary · Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.

Time 1

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	13.4	± .7
Treatment As Usual	11.8	± .7

Time 2

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	8.4	± .9
Treatment As Usual	8.1	± .8

Time 3

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	7.4	± .9
Treatment As Usual	8.3	± .9

Time 4

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	8.0	± .9
Treatment As Usual	7.7	± .9

Time 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy + Treatment As Usual	8.7	± 1.0
Treatment As Usual	8.6	± .9

Adverse events — posted to ClinicalTrials.gov

Time frame: 12-month study participation period. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-Based Cognitive Therapy + Treatment As Usual

Serious: 31/66 (47%)

Deaths: 3/66

Treatment As Usual

Serious: 40/69 (58%)

Deaths: 1/69

Serious adverse events (12 terms)

Reaction	System	Mindfulness-Based Cognitiv…	Treatment As Usual
Psychatric Adverse Events	Psychiatric disorders	—	—
Medical SAE	Cardiac disorders	—	—
Medical SAE	Surgical and medical procedures	—	—
Medical SAE	Endocrine disorders	—	—
Medical SAE	Gastrointestinal disorders	—	—
Medical SAE	Injury, poisoning and procedural complications	—	—
Medical SAE	Nervous system disorders	—	—
SAE Other	Social circumstances	—	—
Medical SAE	General disorders	—	—
Medical SAE	Infections and infestations	—	—
Medical SAE	Respiratory, thoracic and mediastinal disorders	—	—
Medical SAE	Vascular disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Mindfulness-Based Cognitiv…	Treatment As Usual
Psychiatric other (not including serious)	Psychiatric disorders	—	—

Most-reported serious reactions: Psychatric Adverse Events, Medical SAE, Medical SAE, Medical SAE, Medical SAE, Medical SAE, Medical SAE, SAE Other.

Data from ClinicalTrials.gov NCT01872338 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial.
   Interian A, Chesin MS, Stanley B, Latorre M, et al · · 2021 · cited 15× · PMID 34464524 · DOI 10.4088/jcp.20m13791
2. Using Mindfulness-Based Cognitive Therapy to Prevent Suicide among High Suicide Risk Patients who also Misuse Opioids: A Preliminary Probe of Feasibility and Effectiveness.
   Chesin MS, Dave C, Dave C, Myers C, et al · · 2022 · cited 2× · PMID 40129516 · DOI 10.1007/s11469-022-00817-x
3. Initial evaluation of a personalized advantage index to determine which individuals may benefit from mindfulness-based cognitive therapy for suicide prevention.
   Myers CE, Dave CV, Chesin MS, Marx BP, et al · · 2024 · cited 2× · PMID 39306938 · DOI 10.1016/j.brat.2024.104637
4. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide.
   Interian A, Miller R, Dave C, Latorre M, et al · · 2024 · PMID 40134457 · DOI 10.1007/s12671-024-02392-9