Trial Outcomes & Findings for CAMPUS - Feasibility Sub-Study (NCT NCT04728815)
NCT ID: NCT04728815
Last Updated: 2024-02-29
Results Overview
Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
To the end of initial Randomization (up to 1 week)
Results posted on
2024-02-29
Participant Flow
College students seeking treatment at college counseling center. Eligible students endorsed suicidal thoughts at intake.
While they were consented to assure they fully understood the rights and responsibilities of their study role, data about Study Counselors is not collected as it is for the Student Participants. Per CT.gov request, they are however being included as a separate 8th Arm/Group for purposes of this data reporting.
Participant milestones
| Measure |
CAMS to Maintenance
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
|
CAMS to CAMS
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
CAMS to DBT
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
TAU to Maintenance
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU - Phase 1: 4-8 weeks of TAU treatment
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
Study Counselors
Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
10
|
4
|
7
|
1
|
26
|
16
|
|
Overall Study
COMPLETED
|
9
|
3
|
5
|
3
|
3
|
0
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
5
|
1
|
4
|
1
|
12
|
0
|
Reasons for withdrawal
| Measure |
CAMS to Maintenance
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
|
CAMS to CAMS
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
CAMS to DBT
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
TAU to Maintenance
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU - Phase 1: 4-8 weeks of TAU treatment
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
Study Counselors
Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Treatment drop
|
0
|
2
|
1
|
0
|
3
|
1
|
3
|
0
|
|
Overall Study
Study drop
|
0
|
3
|
3
|
0
|
0
|
0
|
7
|
0
|
Baseline Characteristics
CAMPUS - Feasibility Sub-Study
Baseline characteristics by cohort
| Measure |
CAMS to Maintenance
n=12 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
|
CAMS to CAMS
n=8 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
CAMS to DBT
n=10 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
TAU to Maintenance
n=4 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU - Phase 1: 4-8 weeks of TAU treatment
|
TAU to CAMS
n=7 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
n=1 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=26 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
Study Counselors
n=16 Participants
Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
21.08 years
STANDARD_DEVIATION 2.19 • n=5 Participants
|
20.37 years
STANDARD_DEVIATION 2.07 • n=7 Participants
|
20.90 years
STANDARD_DEVIATION 2.38 • n=5 Participants
|
19.25 years
STANDARD_DEVIATION 1.26 • n=4 Participants
|
19.86 years
STANDARD_DEVIATION 1.34 • n=21 Participants
|
20.00 years
STANDARD_DEVIATION 8.00 • n=10 Participants
|
19.88 years
STANDARD_DEVIATION 2.05 • n=115 Participants
|
37.38 years
STANDARD_DEVIATION 9.05 • n=6 Participants
|
20.26 years
STANDARD_DEVIATION 2.03 • n=6 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
60 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
50 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
37 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
84 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: To the end of initial Randomization (up to 1 week)Population: Students meeting all inclusion criteria and no exclusion criteria.
Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported.
Outcome measures
| Measure |
Duke University
n=12 Participants
Duke University (Durham, NC)
|
Rutgers University
n=40 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=54 Participants
University of Nevada, Reno
|
University of Oregon
n=37 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Number of Eligible Students Who Agree to Randomization
|
8 Participants
|
24 Participants
|
20 Participants
|
16 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: To the end of initial counselor recruitment (up to 2 weeks)Population: Counselors meeting all inclusion criteria and no exclusion criteria.
Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate.
Outcome measures
| Measure |
Duke University
n=4 Participants
Duke University (Durham, NC)
|
Rutgers University
n=4 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=4 Participants
University of Nevada, Reno
|
University of Oregon
n=4 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Counselor Recruitment
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: To the end of treatment period (up to 16 weeks)Population: Participants whose DBT sessions were rated.
Existing gold-standard adherence instruments for DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. Each item is rated on a scale where 0 = not used/not necessary, 1-3 = below adherence, 4 = minimum threshold for adherence, and 5 = adherent with high sufficiency. The DBT ACS is scored by averaging all non-zero items to create a computed global score where 3.8 and higher is considered "adherent."
Outcome measures
| Measure |
Duke University
n=6 sessions
Duke University (Durham, NC)
|
Rutgers University
n=53 sessions
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=24 sessions
University of Nevada, Reno
|
University of Oregon
n=24 sessions
University of Oregon (Eugene, OR)
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale
|
3.5 score on a scale
Interval 3.18 to 3.82
|
3.68 score on a scale
Interval 3.61 to 3.75
|
3.72 score on a scale
Interval 3.62 to 3.81
|
3.81 score on a scale
Interval 3.74 to 3.89
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: To the end of treatment period (up to 16 weeks)Population: Participants whose CAMS sessions were rated.
Existing gold-standard adherence instruments for CAMS will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. The measure consists of 14 items evaluating clinician performance, all rated on a seven-point Likert scale ranging from 0 ("Poor") to 6 ("Excellent"). A session is rated as adherent with a score of 3.5 or greater.
Outcome measures
| Measure |
Duke University
n=11 sessions
Duke University (Durham, NC)
|
Rutgers University
n=37 sessions
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=21 sessions
University of Nevada, Reno
|
University of Oregon
n=26 sessions
University of Oregon (Eugene, OR)
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale
|
4.05 score on a scale
Interval 3.37 to 4.73
|
4.66 score on a scale
Interval 4.32 to 5.01
|
4.45 score on a scale
Interval 4.05 to 4.86
|
4.77 score on a scale
Interval 4.39 to 5.15
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: To the end of treatment period (up to 16 weeks)Outcome measures
| Measure |
Duke University
n=12 Participants
Duke University (Durham, NC)
|
Rutgers University
n=8 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=10 Participants
University of Nevada, Reno
|
University of Oregon
n=4 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
n=7 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
n=1 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=26 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Number of Sessions Attended by Students in Each Treatment Condition
|
5.75 sessions
Standard Deviation 1.14
|
5.75 sessions
Standard Deviation 3.28
|
9.10 sessions
Standard Deviation 3.41
|
6.00 sessions
Standard Deviation 0.82
|
7.29 sessions
Standard Deviation 3.35
|
7.00 sessions
Standard Deviation 0.00
|
11.31 sessions
Standard Deviation 4.54
|
PRIMARY outcome
Timeframe: To the end of treatment period (up to 16 weeks)Outcome measures
| Measure |
Duke University
n=12 Participants
Duke University (Durham, NC)
|
Rutgers University
n=8 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=10 Participants
University of Nevada, Reno
|
University of Oregon
n=4 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
n=7 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
n=1 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=26 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial)
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: To the end of treatment period (up to 16 weeks)Population: Participants with data collected.
CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction.
Outcome measures
| Measure |
Duke University
n=11 Participants
Duke University (Durham, NC)
|
Rutgers University
n=5 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=7 Participants
University of Nevada, Reno
|
University of Oregon
n=3 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
n=5 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=21 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Student CSQ at Stage 1 Treatment
|
3.5 score on a scale
Standard Deviation 0.42
|
3.4 score on a scale
Standard Deviation 0.63
|
3.0 score on a scale
Standard Deviation 0.73
|
3.83 score on a scale
Standard Deviation 0.19
|
3.17 score on a scale
Standard Deviation 0.57
|
—
|
3.31 score on a scale
Standard Deviation 0.60
|
|
Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Student CSQ at Stage 2 Treatment
|
—
|
3.67 score on a scale
Standard Deviation 0.38
|
2.47 score on a scale
Standard Deviation 0.40
|
—
|
3.33 score on a scale
Standard Deviation 0.52
|
—
|
3.63 score on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: To end of initial training period (up to 4 weeks)Population: We had 16 total consented counselors, and 2 entire rounds of DBT training, which some attended twice. 8 counselors attended both (8x2=16), while 4 others attended Round 1 only and another 4 attended Round 2 only. Therefore, a total of 24 DBT training ratings for 16 counselors. Ten counselors attended one CAMS session each.
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable).
Outcome measures
| Measure |
Duke University
n=24 Training sessions
Duke University (Durham, NC)
|
Rutgers University
n=10 Training sessions
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
University of Nevada, Reno
|
University of Oregon
University of Oregon (Eugene, OR)
|
TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Counselor Training Satisfaction
|
4.48 score on a scale
Interval 4.18 to 4.78
|
4.70 score on a scale
Interval 4.4 to 5.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: To the end of stage 1 (up to 8 weeks)Population: Participants who completed Stage 1 of treatment.
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.
Outcome measures
| Measure |
Duke University
n=10 Participants
Duke University (Durham, NC)
|
Rutgers University
n=6 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=9 Participants
University of Nevada, Reno
|
University of Oregon
n=4 Participants
University of Oregon (Eugene, OR)
|
TAU to CAMS
n=6 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
n=1 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=24 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
|
3.46 score on a scale
Interval 3.32 to 3.6
|
2.96 score on a scale
Interval 2.71 to 3.21
|
2.92 score on a scale
Interval 2.68 to 3.16
|
3.56 score on a scale
Interval 3.37 to 3.75
|
2.79 score on a scale
Interval 2.7 to 2.88
|
2.88 score on a scale
Interval 2.88 to 2.88
|
2.96 score on a scale
Interval 2.85 to 3.07
|
PRIMARY outcome
Timeframe: Beginning to end of Stage 2 (up to 8 weeks)Population: Participants who completed Stage 2 of treatment.
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.
Outcome measures
| Measure |
Duke University
Duke University (Durham, NC)
|
Rutgers University
n=3 Participants
Rutgers University (New Brunswick, NJ)
|
University of Nevada, Reno
n=6 Participants
University of Nevada, Reno
|
University of Oregon
University of Oregon (Eugene, OR)
|
TAU to CAMS
n=4 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=18 Participants
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
DBT - Phase 1 and 2: up to 16 weeks of DBT treatment
|
|---|---|---|---|---|---|---|---|
|
Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
|
—
|
2.88 score on a scale
Interval 2.75 to 3.01
|
2.90 score on a scale
Interval 2.68 to 3.12
|
—
|
3.00 score on a scale
Interval 3.0 to 3.0
|
—
|
3.24 score on a scale
Interval 3.08 to 3.4
|
Adverse Events
Stage 2 - CAMS to Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 - CAMS to CAMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 - CAMS to DBT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 2 - TAU to Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 - TAU to CAMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 - TAU to DBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DBT Only
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 CAMS
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Stage 1 TAU
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 2 - CAMS to Maintenance
n=12 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
|
Stage 2 - CAMS to CAMS
n=5 participants at risk；n=8 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
Stage 2 - CAMS to DBT
n=9 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
Stage 2 - TAU to Maintenance
n=4 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU - Phase 1: 4-8 weeks of TAU treatment
|
Stage 2 - TAU to CAMS
n=7 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
Stage 2 - TAU to DBT
n=1 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=26 participants at risk
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
No 2nd phase is delineated.
|
Stage 1 CAMS
n=30 participants at risk
All Subjects assigned to Stage 1 CAMS who had a relevant AE during Stage 1.
|
Stage 1 TAU
n=12 participants at risk
All Subjects assigned to Stage 1 TAU who had a relevant AE during Stage 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/5 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/9 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/4 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/7 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/1 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
3.8%
1/26 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
10.0%
3/30 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
8.3%
1/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/5 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/9 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/4 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/7 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/1 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/26 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/30 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
8.3%
1/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
|
Psychiatric disorders
Non-suicidal self-injury
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/5 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/9 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/4 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/7 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/1 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
3.8%
1/26 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/30 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
|
General disorders
Other non-mental health event
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/5 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/9 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/4 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/7 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/1 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
7.7%
2/26 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
3.3%
1/30 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
Other adverse events
| Measure |
Stage 2 - CAMS to Maintenance
n=12 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
|
Stage 2 - CAMS to CAMS
n=5 participants at risk；n=8 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
Stage 2 - CAMS to DBT
n=9 participants at risk
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
Stage 2 - TAU to Maintenance
n=4 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU - Phase 1: 4-8 weeks of TAU treatment
|
Stage 2 - TAU to CAMS
n=7 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU - Phase 1: 4-8 weeks of TAU treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
|
Stage 2 - TAU to DBT
n=1 participants at risk
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
TAU - Phase 1: 4-8 weeks of TAU treatment
DBT - Phase 2: Up to 8 weeks of DBT treatment
|
DBT Only
n=26 participants at risk
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
No 2nd phase is delineated.
|
Stage 1 CAMS
n=30 participants at risk
All Subjects assigned to Stage 1 CAMS who had a relevant AE during Stage 1.
|
Stage 1 TAU
n=12 participants at risk
All Subjects assigned to Stage 1 TAU who had a relevant AE during Stage 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Evidence of distress during assessments
|
0.00%
0/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/5 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
11.1%
1/9 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/4 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/7 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
0.00%
0/1 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
11.5%
3/26 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
30.0%
9/30 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
25.0%
3/12 • To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects. Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place