Trial Outcomes & Findings for An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients (NCT NCT03442699)
NCT ID: NCT03442699
Last Updated: 2020-01-02
Results Overview
The CSSRS intensity subscale measures frequency, duration, controllability, deterrents, and reasons for suicidal ideation. The scale ranges from 2-25 with higher scores indicating more severe suicidal ideation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Pre-treatment, after treatment which was an average of 16 days, and through follow up, an average of 3 months post-treatment
Results posted on
2020-01-02
Participant Flow
8 participants were consented. Two were excluded for comorbid substance use disorder. 6 participants initiated treatment.
Participant milestones
| Measure |
Cognitive Behavioral Therapy
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
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|---|---|
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Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
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6
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy
n=6 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
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|---|---|
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Age, Continuous
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33.50 years
STANDARD_DEVIATION 15.36 • n=5 Participants
|
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Sex: Female, Male
Female
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6 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, after treatment which was an average of 16 days, and through follow up, an average of 3 months post-treatmentPopulation: On participant was lost to follow-up and did not complete the 3 month follow-up assessment
The CSSRS intensity subscale measures frequency, duration, controllability, deterrents, and reasons for suicidal ideation. The scale ranges from 2-25 with higher scores indicating more severe suicidal ideation.
Outcome measures
| Measure |
Pre Cognitive Behavioral Therapy
n=6 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
|
Post Cognitive Behavioral Therapy
n=6 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
|
3 Month Follow-up
n=5 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
|
|---|---|---|---|
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Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale.
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13.0 score on a scale
Standard Deviation 6.51
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2.50 score on a scale
Standard Deviation 6.12
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2.60 score on a scale
Standard Deviation 5.81
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SECONDARY outcome
Timeframe: Pre-treatment through post-treatment up to 24 days, 16 days on averageThe SIGH-D is a clinician rated measure of depression symptom severity. Scores range from 0 to 52 with higher total scores indicating more severe depression.
Outcome measures
| Measure |
Pre Cognitive Behavioral Therapy
n=6 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
|
Post Cognitive Behavioral Therapy
n=6 Participants
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
|
3 Month Follow-up
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
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|---|---|---|---|
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Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D)
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15.0 score on a scale
Standard Deviation 7.97
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6.17 score on a scale
Standard Deviation 3.60
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—
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Adverse Events
Cognitive-Behavioral Therapy
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 |
Cognitive-Behavioral Therapy
n=6 participants at risk
All participants received cognitive-behavioral therapy
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|---|---|
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Gastrointestinal disorders
vomiting
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16.7%
1/6 • Number of events 1 • Pre-treatment, after treatment up to 24 days, and through follow up, an average of 3 months post-treatment.
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Additional Information
David Tolin, Ph.D.
Hartford Hospital/Institute of Living
Phone: 860-545-7685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place