Trial Outcomes & Findings for Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1 (NCT NCT04689867)
NCT ID: NCT04689867
Last Updated: 2023-04-24
Results Overview
A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Results posted on
2023-04-24
Participant Flow
A total of eight clients consented to participate in the Aim 1 open pilot study and were subsequently scheduled to attend a screening assessment. One individual was not eligible per the screening assessment, and two individuals did not attend the scheduled screening assessment. As a result, five individuals were eligible to participate and began treatment.
Participant milestones
| Measure |
CBSPp
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis.
In this open pilot trial, all participants received the treatment.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1
Baseline characteristics by cohort
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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Age, Continuous
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44.66 years
STANDARD_DEVIATION 13.06 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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5 participants
n=5 Participants
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Lifetime History of Suicide Attempt
Yes
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4 Participants
n=5 Participants
|
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Lifetime History of Suicide Attempt
No
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1 Participants
n=5 Participants
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Past Week Suicide Attempt
Yes
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0 Participants
n=5 Participants
|
|
Past Week Suicide Attempt
No
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5 Participants
n=5 Participants
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Past Week Suicide Ideation
Yes
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3 Participants
n=5 Participants
|
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Past Week Suicide Ideation
No
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2 Participants
n=5 Participants
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Past Week Suicide Plan
Yes
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3 Participants
n=5 Participants
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Past Week Suicide Plan
No
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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Calgary Depression Rating Scale (CDRS)
Baseline
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13.60 score on a scale
Standard Deviation 5.73
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Calgary Depression Rating Scale (CDRS)
mid-treatment
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9.00 score on a scale
Standard Deviation 2.92
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Calgary Depression Rating Scale (CDRS)
post-treatment
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11.00 score on a scale
Standard Deviation 2.58
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Calgary Depression Rating Scale (CDRS)
follow-up
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7.60 score on a scale
Standard Deviation 3.65
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PRIMARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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Positive and Negative Symptom Rating Scale (PANSS)
Post-treatment negative sub scale
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17.75 score on a scale
Standard Deviation 6.40
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Positive and Negative Symptom Rating Scale (PANSS)
Baseline positive sub scale
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20.20 score on a scale
Standard Deviation 3.27
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Positive and Negative Symptom Rating Scale (PANSS)
Baseline negative sub scale
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18.20 score on a scale
Standard Deviation 5.89
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Positive and Negative Symptom Rating Scale (PANSS)
Baseline general sub scale
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42.40 score on a scale
Standard Deviation 7.96
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Positive and Negative Symptom Rating Scale (PANSS)
Mid-treatment positive sub scale
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20.40 score on a scale
Standard Deviation 4.16
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Positive and Negative Symptom Rating Scale (PANSS)
Mid-treatment negative sub scale
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19.00 score on a scale
Standard Deviation 7.81
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Positive and Negative Symptom Rating Scale (PANSS)
Mid-treatment general sub scale
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41.20 score on a scale
Standard Deviation 8.53
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Positive and Negative Symptom Rating Scale (PANSS)
Post-treatment positive sub scale
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20.00 score on a scale
Standard Deviation 7.62
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Positive and Negative Symptom Rating Scale (PANSS)
Post-treatment general sub scale
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37.50 score on a scale
Standard Deviation 10.38
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Positive and Negative Symptom Rating Scale (PANSS)
Follow-up positive sub scale
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20.80 score on a scale
Standard Deviation 7.66
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Positive and Negative Symptom Rating Scale (PANSS)
Follow-up negative sub scale
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18.00 score on a scale
Standard Deviation 8.25
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Positive and Negative Symptom Rating Scale (PANSS)
Follow-up general sub scale
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43.4 score on a scale
Standard Deviation 12.42
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PRIMARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)Population: One individual at post-treatment did not complete the assessment with research staff
A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide ideation · Yes
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3 Participants
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide ideation · No
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2 Participants
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide plan · Yes
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3 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide plan · No
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2 Participants
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide attempt · Yes
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0 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline suicide attempt · No
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5 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide ideation · Yes
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3 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide ideation · No
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2 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide plan · Yes
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4 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide plan · No
|
1 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide attempt · Yes
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0 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Mid-treatment suicide attempt · No
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5 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide ideation · Yes
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2 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide ideation · No
|
2 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide plan · Yes
|
1 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide plan · No
|
3 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide attempt · Yes
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0 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-treatment suicide attempt · No
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4 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide ideation · Yes
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3 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide ideation · No
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2 Participants
|
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Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide plan · Yes
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2 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide plan · No
|
3 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide attempt · Yes
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0 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up suicide attempt · No
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5 Participants
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SECONDARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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Beck Hopelessness Scale
Baseline
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12.80 score on a scale
Standard Deviation 8.17
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Beck Hopelessness Scale
Mid-treatment
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10.40 score on a scale
Standard Deviation 8.76
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Beck Hopelessness Scale
Post-treatment
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12.00 score on a scale
Standard Deviation 7.44
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Beck Hopelessness Scale
Follow-up
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9.80 score on a scale
Standard Deviation 8.87
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SECONDARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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The Entrapment Scale
Baseline
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35.80 score on a scale
Standard Deviation 15.61
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The Entrapment Scale
Mid-treatment
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30.40 score on a scale
Standard Deviation 21.10
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The Entrapment Scale
Post-treatment
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28.75 score on a scale
Standard Deviation 18.39
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The Entrapment Scale
Follow-up
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36.0 score on a scale
Standard Deviation 21.09
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SECONDARY outcome
Timeframe: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.
Outcome measures
| Measure |
CBSPp
n=5 Participants
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
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|---|---|
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The Defeat Scale
Baseline
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43.00 score on a scale
Standard Deviation 18.41
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The Defeat Scale
Mid-treatment
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40.40 score on a scale
Standard Deviation 20.62
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The Defeat Scale
Post-treatment
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39.00 score on a scale
Standard Deviation 15.43
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The Defeat Scale
Follow-up
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41.5 score on a scale
Standard Deviation 14.27
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Adverse Events
CBSPp
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBSPp
n=5 participants at risk
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis.
In this open pilot trial, all participants received the treatment.
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|---|---|
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Psychiatric disorders
Anxiety during assessment
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20.0%
1/5 • Number of events 1 • Adverse event data collected across participant involvement in study (beginning with the eligibility screener and ending after follow-up assessment): Approximately across 5 months per participant
Systematic Assessment of Adverse Events: Routine determination of adverse events through standard assessment at each study timepoints by research staff, project coordinator, or principal investigator.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place