Trial Outcomes & Findings for Isolating Mechanisms in the Treatment of Borderline Personality Disorder (NCT NCT03408860)
NCT ID: NCT03408860
Last Updated: 2022-11-16
Results Overview
The Multidimensional Experiential Avoidance Questionnaire - Distress Aversion subscale (MEAQ-DA) assesses aversive reactions to emotional experiences. Total scores representing a sum of items range from 13 to 78, which lower scores indicating more adaptive psychological functioning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
pre-treatment (baseline), post-treatment (4 weeks)
Results posted on
2022-11-16
Participant Flow
Participant milestones
| Measure |
2-week Baseline
Patients complete assessment only for a duration of 2-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
4-week Baseline
Patient complete assessment only for a duration of 4-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Isolating Mechanisms in the Treatment of Borderline Personality Disorder
Baseline characteristics by cohort
| Measure |
2-week Baseline
n=4 Participants
Patients complete assessment only for a duration of 2-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
4-week Baseline
n=4 Participants
Patient complete assessment only for a duration of 4-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.67 Years
n=5 Participants
|
20.75 Years
n=7 Participants
|
21.57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-treatment (baseline), post-treatment (4 weeks)The Multidimensional Experiential Avoidance Questionnaire - Distress Aversion subscale (MEAQ-DA) assesses aversive reactions to emotional experiences. Total scores representing a sum of items range from 13 to 78, which lower scores indicating more adaptive psychological functioning.
Outcome measures
| Measure |
2-week Baseline
n=4 Participants
Patients complete assessment only for a duration of 2-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
4-week Baseline
n=4 Participants
Patient complete assessment only for a duration of 4-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
|---|---|---|
|
Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscale
pre-treatment
|
23.21 score on a scale
Standard Deviation 7.15
|
23.21 score on a scale
Standard Deviation 7.15
|
|
Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscale
post-treatment
|
19.93 score on a scale
Standard Deviation 7.95
|
19.93 score on a scale
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (4 weeks)The Zanarini Rating Scale for BPD (ZAN-BPD) is a self-report measures that assesses borderline personality disorder symptoms. The total score ranges from 0 to 27 with higher scores representing poorer psychological functioning.
Outcome measures
| Measure |
2-week Baseline
n=4 Participants
Patients complete assessment only for a duration of 2-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
4-week Baseline
n=4 Participants
Patient complete assessment only for a duration of 4-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
Countering Emotional Behaviors Module from Unified Protocol: This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
|
|---|---|---|
|
Zanarini Rating Scale for BPD
pre-treatment
|
9.59 score on a scale
Standard Deviation 4.71
|
9.59 score on a scale
Standard Deviation 4.71
|
|
Zanarini Rating Scale for BPD
post treatment
|
7.12 score on a scale
Standard Deviation 5.78
|
7.12 score on a scale
Standard Deviation 5.78
|
Adverse Events
2-week Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4-week Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place