Trial Outcomes & Findings for Mindfulness-Based Cognitive Therapy for Suicide Prevention (NCT NCT01872338)

Last Updated: 2020-05-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

135 participants

Primary outcome timeframe

12-months post-baseline

Results posted on

2020-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Overall Study STARTED	66	69
Overall Study COMPLETED	46	69
Overall Study NOT COMPLETED	20	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-Based Cognitive Therapy for Suicide Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 Participants Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 Participants VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention	Total n=135 Participants Total of all reporting groups
Age, Continuous	47.54 years STANDARD_DEVIATION 13.2 • n=93 Participants	45.97 years STANDARD_DEVIATION 14.3 • n=4 Participants	46.96 years STANDARD_DEVIATION 11.9 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	59 Participants n=93 Participants	60 Participants n=4 Participants	119 Participants n=27 Participants
Race/Ethnicity, Customized RACE/ETHNICITY · White	30 Participants n=93 Participants	31 Participants n=4 Participants	61 Participants n=27 Participants
Race/Ethnicity, Customized RACE/ETHNICITY · Black	15 Participants n=93 Participants	21 Participants n=4 Participants	36 Participants n=27 Participants
Race/Ethnicity, Customized RACE/ETHNICITY · Asian, American Indian, or other	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized RACE/ETHNICITY · Latino	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Region of Enrollment United States	66 Participants n=93 Participants	69 Participants n=4 Participants	135 Participants n=27 Participants
Suicide Attempt History none	9 Participants n=93 Participants	12 Participants n=4 Participants	21 Participants n=27 Participants
Suicide Attempt History one	21 Participants n=93 Participants	17 Participants n=4 Participants	38 Participants n=27 Participants
Suicide Attempt History multiple	36 Participants n=93 Participants	40 Participants n=4 Participants	76 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12-months post-baseline

Population: Total number of suicidal events within the 12-month observation period by study condition.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 Participants Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 Participants VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Suicide Event	44 count of events	92 count of events

SECONDARY outcome

Timeframe: 12 months post-baseline

Population: count of suicide attempts over 12-month period by study condition

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 Participants Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 Participants VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Suicide Attempt	11 count of suicide attempts	27 count of suicide attempts

SECONDARY outcome

Timeframe: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

Population: Linear mixed models, examining change from baseline over 12 months (5 assessments total), with effect of interest being time\*cond interaction.

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 Participants Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 Participants VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Suicidal Ideation Time 1	12.4 score on a scale Standard Error 1.2	11.2 score on a scale Standard Error 1.2
Suicidal Ideation Time 2	5.8 score on a scale Standard Error 1.2	6.1 score on a scale Standard Error 1.2
Suicidal Ideation Time 3	4.8 score on a scale Standard Error 1.1	4.7 score on a scale Standard Error 1.0
Suicidal Ideation Time 4	6.1 score on a scale Standard Error 1.1	3.3 score on a scale Standard Error 1.0
Suicidal Ideation Time 5	3.8 score on a scale Standard Error .9	2.3 score on a scale Standard Error .8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 Participants Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 Participants VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Hopelessness Time 1	13.4 score on a scale Standard Error .7	11.8 score on a scale Standard Error .7
Hopelessness Time 2	8.4 score on a scale Standard Error .9	8.1 score on a scale Standard Error .8
Hopelessness Time 3	7.4 score on a scale Standard Error .9	8.3 score on a scale Standard Error .9
Hopelessness Time 4	8.0 score on a scale Standard Error .9	7.7 score on a scale Standard Error .9
Hopelessness Time 5	8.7 score on a scale Standard Error 1.0	8.6 score on a scale Standard Error .9

Adverse Events

Mindfulness-Based Cognitive Therapy + Treatment As Usual

Serious events: 31 serious events

Other events: 4 other events

Deaths: 3 deaths

Treatment As Usual

Serious events: 40 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 participants at risk Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 participants at risk VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Psychiatric disorders Psychatric Adverse Events	39.4% 26/66 • Number of events 45 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	53.6% 37/69 • Number of events 85 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Cardiac disorders Medical SAE	4.5% 3/66 • Number of events 5 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	4.3% 3/69 • Number of events 3 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Endocrine disorders Medical SAE	3.0% 2/66 • Number of events 2 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	0.00% 0/69 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Gastrointestinal disorders Medical SAE	3.0% 2/66 • Number of events 2 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
General disorders Medical SAE	1.5% 1/66 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Infections and infestations Medical SAE	0.00% 0/66 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Injury, poisoning and procedural complications Medical SAE	0.00% 0/66 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	2.9% 2/69 • Number of events 2 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Nervous system disorders Medical SAE	3.0% 2/66 • Number of events 2 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Respiratory, thoracic and mediastinal disorders Medical SAE	1.5% 1/66 • Number of events 3 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Surgical and medical procedures Medical SAE	4.5% 3/66 • Number of events 3 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	0.00% 0/69 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Vascular disorders Medical SAE	0.00% 0/66 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	1.4% 1/69 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB
Social circumstances SAE Other	1.5% 1/66 • Number of events 1 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	2.9% 2/69 • Number of events 2 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB

Other adverse events

Other adverse events
Measure	Mindfulness-Based Cognitive Therapy + Treatment As Usual n=66 participants at risk Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.	Treatment As Usual n=69 participants at risk VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention
Psychiatric disorders Psychiatric other (not including serious)	6.1% 4/66 • Number of events 6 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB	5.8% 4/69 • Number of events 7 • 12-month study participation period all serious adverse events were reported to IRB and reviewed by a DSMB

Additional Information

Alejandro Interian, PHD

VA New Jersey Healthcare System

Phone: 908-647-0180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place