Trial Outcomes & Findings for Veterans Coping Long-term With Active Suicide (NCT NCT01894841)

Last Updated: 2020-02-10

Results Overview

Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality.

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

baseline, 3, 6, 9, & 12 month post-hospitalization

Results posted on

2020-02-10

Participant Flow

Participants were recruited from the Providence VA Medical center psychiatric inpatient unit

One hundred and seven participants completed baseline assessments and were found to be eligible for the study. Two participants were lost prior to randomization since they could not be contacted by research staff.

Participant milestones

Participant milestones
Measure	CLASP Intervention The Coping Long Term with Active Suicide is a 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers. Coping Long Term with Active Suicide: an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent.
Overall Study STARTED	52	53
Overall Study COMPLETED	34	44
Overall Study NOT COMPLETED	18	9

Reasons for withdrawal

Reasons for withdrawal
Measure	CLASP Intervention The Coping Long Term with Active Suicide is a 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers. Coping Long Term with Active Suicide: an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent.
Overall Study Withdrawal by Subject	9	4
Overall Study Withdrawn by investigator	2	2
Overall Study Lost to Follow-up	7	3

Baseline Characteristics

2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: baseline, 3, 6, 9, & 12 month post-hospitalization

Population: The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=25 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=34 Participants Treatment as usual plus enhanced monitoring.
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior Baseline	0.13 log(attempts) Standard Deviation 0.16	0.18 log(attempts) Standard Deviation 0.21
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior 3 Month Followup	0.14 log(attempts) Standard Deviation 0.30	0.05 log(attempts) Standard Deviation 0.16
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior 6 Month Followup	0.06 log(attempts) Standard Deviation 0.15	0.01 log(attempts) Standard Deviation 0.08
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior 9 Month Followup	0.09 log(attempts) Standard Deviation 0.22	0.03 log(attempts) Standard Deviation 0.11
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior 12 Month Followup	0.06 log(attempts) Standard Deviation 0.17	0.03 log(attempts) Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, & 12 month follow up

Population: 2 participants from the CLASP condition were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. Number of participants analyzed is smaller per group due to dropout from baseline to 12 month follow-up and missing data for some time points.

The Beck Hopelessness Scale was used to measure changes in hopelessness from baseline to 12-month followup. Items are dichotomous (0: False and 1: True), with a total score ranging from 0-20. Higher scores indicate greater hopelessness.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=17 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=29 Participants Treatment as usual plus enhanced monitoring.
Changes in Beck Hopelessness Scale Baseline	13.65 score on a scale Standard Deviation 5.62	13.21 score on a scale Standard Deviation 5.16
Changes in Beck Hopelessness Scale 3 Month Followup	9.12 score on a scale Standard Deviation 6.59	9.28 score on a scale Standard Deviation 7.32
Changes in Beck Hopelessness Scale 6 Month Followup	10.06 score on a scale Standard Deviation 7.50	9.28 score on a scale Standard Deviation 6.41
Changes in Beck Hopelessness Scale 9 Month Followup	8.65 score on a scale Standard Deviation 7.13	7.31 score on a scale Standard Deviation 6.50
Changes in Beck Hopelessness Scale 12 Month Followup	9.00 score on a scale Standard Deviation 6.78	7.58 score on a scale Standard Deviation 6.72

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, & 12 month follow up

Population: There are fewer subjects in this analysis than were recruited for both groups at baseline due to dropout across timepoints.

The Brief Symptom Inventory is a validated, self-reported instrument assessing current psychiatric symptomatology. Possible scores for each item range from 0 (not at all) to 4 (extremely), and total scores are represented by a Global Severity Index (range 0 to 212).Higher scores indicate greater psychological distress.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=18 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=30 Participants Treatment as usual plus enhanced monitoring.
Brief Symptom Inventory Baseline	1.93 score on a scale Standard Deviation 0.68	1.98 score on a scale Standard Deviation 0.65
Brief Symptom Inventory 3 Month Followup	1.30 score on a scale Standard Deviation 0.90	1.17 score on a scale Standard Deviation 0.84
Brief Symptom Inventory 6 Month Followup	1.26 score on a scale Standard Deviation 0.84	1.23 score on a scale Standard Deviation 0.86
Brief Symptom Inventory 9 Month Followup	0.93 score on a scale Standard Deviation 0.75	1.10 score on a scale Standard Deviation 0.86
Brief Symptom Inventory 12 Month Followup	1.08 score on a scale Standard Deviation 0.90	1.06 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, & 12 month follow ups

Population: The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.

The World Health Organization Disability Assessment Schedule (WHODAS II) is a validated, self-reported instrument assessing current impairment in functioning. Possible scores for each item range from 1 (None) to 5 (Extreme or cannot do). We calculated an Average Global Score for inclusion in analyses by dividing the total score by the number of items included in the measure (possible range of 1-5). Higher scores indicate greater impairment in functioning. We examined changes in overall functioning from baseline in these analyses.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=17 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=30 Participants Treatment as usual plus enhanced monitoring.
World Health Organization Disability Assessment Schedule (WHODAS) II Baseline	2.58 score on a scale Standard Deviation 0.55	2.54 score on a scale Standard Deviation 0.69
World Health Organization Disability Assessment Schedule (WHODAS) II 3 Month Followup	2.12 score on a scale Standard Deviation 0.78	2.09 score on a scale Standard Deviation 0.79
World Health Organization Disability Assessment Schedule (WHODAS) II 6 Month Followup	2.17 score on a scale Standard Deviation 0.72	2.07 score on a scale Standard Deviation 0.71
World Health Organization Disability Assessment Schedule (WHODAS) II 9 Month Followup	2.00 score on a scale Standard Deviation 0.61	1.93 score on a scale Standard Deviation 0.76
World Health Organization Disability Assessment Schedule (WHODAS) II 1 Year Followup	2.08 score on a scale Standard Deviation 0.82	2.04 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: 3, 6, 9, & 12 month follow up

Population: The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.

We used an item measuring psychiatric hospitalizations from the Treatment History Interview to measure treatment utilization. Study participants indicated how many times they had been psychiatrically hospitalized since the prior study timepoint. We log transformed this variable at each timepoint to meet statistical assumptions of normality for our analyses.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=23 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=32 Participants Treatment as usual plus enhanced monitoring.
Treatment History Interview 3 Month Followup	0.12 log(psychiatric hospitalizations) Standard Deviation 0.20	0.07 log(psychiatric hospitalizations) Standard Deviation 0.16
Treatment History Interview 6 Month Followup	0.03 log(psychiatric hospitalizations) Standard Deviation 0.09	0.06 log(psychiatric hospitalizations) Standard Deviation 0.14
Treatment History Interview 9 Month Followup	0.04 log(psychiatric hospitalizations) Standard Deviation 0.10	0.06 log(psychiatric hospitalizations) Standard Deviation 0.12
Treatment History Interview 12 Month Followup	0.05 log(psychiatric hospitalizations) Standard Deviation 0.13	0.07 log(psychiatric hospitalizations) Standard Deviation 0.14

SECONDARY outcome

Timeframe: baseline, 3, 6, 9, & 12 month post-hospitalization

Population: The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.

Intensity of ideation was measured using the Columbia Scale for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. Minimum score on the ideation measure is 1 and maximum score is 5.

Outcome measures

Outcome measures
Measure	CLASP Intervention n=25 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=32 Participants Treatment as usual plus enhanced monitoring.
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity Baseline	3.88 units on a scale Standard Deviation 0.73	4.16 units on a scale Standard Deviation 0.92
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity 3 Month Followup	2.56 units on a scale Standard Deviation 1.78	2.47 units on a scale Standard Deviation 1.81
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity 6 Month Followup	2.08 units on a scale Standard Deviation 1.91	1.66 units on a scale Standard Deviation 1.77
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity 9 Month Followup	1.64 units on a scale Standard Deviation 1.91	1.38 units on a scale Standard Deviation 1.74
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity 12 Month Followup	1.84 units on a scale Standard Deviation 1.89	1.25 units on a scale Standard Deviation 1.61

Adverse Events

CLASP Intervention

Serious events: 21 serious events

Other events: 0 other events

Deaths: 1 deaths

Safety Assessment and Follow up Evaluation

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CLASP Intervention n=52 participants at risk A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.	Safety Assessment and Follow up Evaluation n=53 participants at risk Treatment as usual plus enhanced monitoring.
Gastrointestinal disorders Hospitalization for medical condition	1.9% 1/52 • Number of events 1 • Adverse event data for each participant was collected for 12 months following baseline assessments.	0.00% 0/53 • Adverse event data for each participant was collected for 12 months following baseline assessments.
Psychiatric disorders Hospitalization for suicide ideation or behavior	26.9% 14/52 • Number of events 19 • Adverse event data for each participant was collected for 12 months following baseline assessments.	17.0% 9/53 • Number of events 13 • Adverse event data for each participant was collected for 12 months following baseline assessments.
Psychiatric disorders Hospitalization for substance use disorders	3.8% 2/52 • Number of events 4 • Adverse event data for each participant was collected for 12 months following baseline assessments.	7.5% 4/53 • Number of events 7 • Adverse event data for each participant was collected for 12 months following baseline assessments.
Cardiac disorders Hospitalization for chest pain	1.9% 1/52 • Number of events 3 • Adverse event data for each participant was collected for 12 months following baseline assessments.	0.00% 0/53 • Adverse event data for each participant was collected for 12 months following baseline assessments.
Psychiatric disorders Hospitalization for excarbation of psychiatric symptoms	7.7% 4/52 • Number of events 7 • Adverse event data for each participant was collected for 12 months following baseline assessments.	11.3% 6/53 • Number of events 8 • Adverse event data for each participant was collected for 12 months following baseline assessments.
General disorders Hospitalization for pain	3.8% 2/52 • Number of events 2 • Adverse event data for each participant was collected for 12 months following baseline assessments.	3.8% 2/53 • Number of events 2 • Adverse event data for each participant was collected for 12 months following baseline assessments.
General disorders Medical hospitalization	3.8% 2/52 • Number of events 2 • Adverse event data for each participant was collected for 12 months following baseline assessments.	0.00% 0/53 • Adverse event data for each participant was collected for 12 months following baseline assessments.

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Primack

Providence VAMC

Phone: 401 273-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CLASP Intervention + Enhanced Monitoring n=52 Participants A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. Plus Enhanced monitoring consisting of assessment and medical record notes sent to mental health providers.	Safety Assessment and Follow up Evaluation + TAU n=53 Participants Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers.	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	0 Participants n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	0 Participants n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Age, Categorical Between 18 and 65 years	48 Participants n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	47 Participants n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	95 Participants n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Age, Categorical >=65 years	2 Participants n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	6 Participants n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	8 Participants n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Age, Continuous	46.56 years STANDARD_DEVIATION 14.07 • n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	48.85 years STANDARD_DEVIATION 14.76 • n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	47.74 years STANDARD_DEVIATION 14.40 • n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Sex: Female, Male Female	4 Participants n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	4 Participants n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	8 Participants n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Sex: Female, Male Male	46 Participants n=50 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	49 Participants n=53 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.	95 Participants n=103 Participants • 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	2 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	2 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) Asian	0 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	1 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	1 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	0 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	0 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) Black or African American	1 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	4 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	5 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) White	46 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	42 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	88 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) More than one race	1 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	3 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	4 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=50 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	1 Participants n=53 Participants • 2 participants in the CLASP condition failed to complete baseline measures.	3 Participants n=103 Participants • 2 participants in the CLASP condition failed to complete baseline measures.
Region of Enrollment United States	52 Participants n=52 Participants	53 Participants n=53 Participants	105 Participants n=105 Participants
Beck Hopelessness Scale	12.98 units on a scale STANDARD_DEVIATION 5.69 • n=48 Participants • In the CLASP condition, 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. An additional 2 failed to complete the full BHI 2 participants in the SAFE condition did not complete the BHI	12.96 units on a scale STANDARD_DEVIATION 5.53 • n=51 Participants • In the CLASP condition, 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. An additional 2 failed to complete the full BHI 2 participants in the SAFE condition did not complete the BHI	12.97 units on a scale STANDARD_DEVIATION 5.58 • n=99 Participants • In the CLASP condition, 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. An additional 2 failed to complete the full BHI 2 participants in the SAFE condition did not complete the BHI
Columbia Suicide Severity Rating Scale -Ideation	4.28 units on a scale STANDARD_DEVIATION .730 • n=50 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.	4.26 units on a scale STANDARD_DEVIATION .836 • n=53 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.	4.27 units on a scale STANDARD_DEVIATION .782 • n=103 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.
Columbia Suicide Severity Rating Scale - Attempt Behavior	1.40 Suicide attempts STANDARD_DEVIATION 1.76 • n=50 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.	1.55 Suicide attempts STANDARD_DEVIATION 2.06 • n=53 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.	1.48 Suicide attempts STANDARD_DEVIATION 1.92 • n=103 Participants • 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.
WHODAS	93.02 units on a scale STANDARD_DEVIATION 21.84 • n=48 Participants • 2 participants in CLASP condition were lost prior to baseline completion and 2 additional participants failed to complete the WHODAS 3 participants in the control condition failed to complete the full WHODAS	92.78 units on a scale STANDARD_DEVIATION 23.67 • n=50 Participants • 2 participants in CLASP condition were lost prior to baseline completion and 2 additional participants failed to complete the WHODAS 3 participants in the control condition failed to complete the full WHODAS	92.90 units on a scale STANDARD_DEVIATION 22.69 • n=98 Participants • 2 participants in CLASP condition were lost prior to baseline completion and 2 additional participants failed to complete the WHODAS 3 participants in the control condition failed to complete the full WHODAS
Brief Symptom Inventory	2.02 units on a scale STANDARD_DEVIATION .67 • n=50 Participants • 2 participants in the CLASp condition were lost prior to completing baseline measures. In the SAFE condition, 1 participant had missing data on the BSI	1.99 units on a scale STANDARD_DEVIATION .68 • n=52 Participants • 2 participants in the CLASp condition were lost prior to completing baseline measures. In the SAFE condition, 1 participant had missing data on the BSI	2.00 units on a scale STANDARD_DEVIATION .68 • n=102 Participants • 2 participants in the CLASp condition were lost prior to completing baseline measures. In the SAFE condition, 1 participant had missing data on the BSI