Trial Outcomes & Findings for Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy (NCT NCT04626310)
NCT ID: NCT04626310
Last Updated: 2024-11-27
Results Overview
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week\^2). This measure reflects the Quadratic measure.
COMPLETED
NA
84 participants
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
2024-11-27
Participant Flow
N=115 recruited from the area around western MA assessed for eligibility but only 84 enrolled in study. .
Due to group design, participants waited for next group date to begin treatment
Participant milestones
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
29
|
|
Overall Study
COMPLETED
|
20
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
8
|
Reasons for withdrawal
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Overall Study
4-miss from treatment
|
6
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
Baseline Characteristics
Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)
Baseline characteristics by cohort
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
26.41 years
STANDARD_DEVIATION 11.71 • n=99 Participants
|
25.75 years
STANDARD_DEVIATION 9.95 • n=107 Participants
|
24.72 years
STANDARD_DEVIATION 7.21 • n=206 Participants
|
25.61 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
28 participants
n=107 Participants
|
29 participants
n=206 Participants
|
84 participants
n=7 Participants
|
|
DERS total
|
118.525 units on a scale
STANDARD_DEVIATION 23.707 • n=99 Participants • Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)
|
116.539 units on a scale
STANDARD_DEVIATION 21.399 • n=107 Participants • Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)
|
120.915 units on a scale
STANDARD_DEVIATION 23.707 • n=206 Participants • Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)
|
118.688 units on a scale
STANDARD_DEVIATION 21.363 • n=7 Participants • Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)
|
PRIMARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Population: ITT sample (see study description)
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week\^2). This measure reflects the Linear measure.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Emotional Functioning - Linear
|
-.917 DERS scores/wk
Standard Error .31
|
-1.25 DERS scores/wk
Standard Error .32
|
-1.01 DERS scores/wk
Standard Error .26
|
PRIMARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Population: missing 1 data point for DBT-ER group
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled \*100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week\^2). This measure reflects the Linear measure.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=26 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Borderline Personality Disorder Features - Linear
|
-1.716 BSL scores/wk
Standard Error .808
|
-3.567 BSL scores/wk
Standard Error .746
|
-3.667 BSL scores/wk
Standard Error .833
|
PRIMARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Population: ITT sample (see study description)
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week\^2). This measure reflects the Quadratic measure.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Emotional Functioning - Quad
|
-.06 DERS scores/wk^2
Standard Error .04
|
-.04 DERS scores/wk^2
Standard Error .04
|
-.07 DERS scores/wk^2
Standard Error .03
|
PRIMARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Population: missing 1 data point for DBT-ER group from ITT sample
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled \*100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week\^2). This measure reflects the Quadratic measure.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=26 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Borderline Personality Disorder Features - Quad
|
-.162 BSL scores/wk^2
Standard Error .108
|
-.163 BSL scores/wk^2
Standard Error .095
|
-.135 BSL scores/wk^2
Standard Error .100
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (Neg: neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between neutral and negative-maintain over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Self-reported Emotional Reactivity
|
-.07 Condition diff (Neg-Neu) in NA scores/wk
Standard Error .06
|
-.09 Condition diff (Neg-Neu) in NA scores/wk
Standard Error .06
|
-.12 Condition diff (Neg-Neu) in NA scores/wk
Standard Error .06
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: with emotional maintain (Main) instructions, and negative with decrease (Dec) instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between Reg conditions in response to negative stimuli (negative-decrease and negative-maintain) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/ multilevel models.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Self-reported Emotional Regulation
|
-.18 Condition diff (Reg) in NA score/wk
Standard Error .07
|
-.01 Condition diff (Reg) in NA score/wk
Standard Error .07
|
.15 Condition diff (Reg) in NA score/wk
Standard Error .07
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Population: Some participants were missing data due to nonattendance at lab sessions
Assessed with eyeblink startle amplitude (mV) in response to emotional cues presented in the lab (of note, per protocol, we examined eyeblink in response to negative and neutral image stimuli across initial \[novel\] and repeated presentations) which were presented along with sound bursts to elicit startle. This outcome was transformed and then rescaled (\*100, = mVtr). Outcomes are reported as slopes per condition over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models with image valence (Neg: negative vs. neutral) and type (Novel: novel vs. repeated) within-person condition effects.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=25 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=25 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=25 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Affect-modulated Startle
|
.015 Condition diff (NegXNovel) in Mn mVtr/Wk
Standard Error .041
|
.043 Condition diff (NegXNovel) in Mn mVtr/Wk
Standard Error .040
|
-.076 Condition diff (NegXNovel) in Mn mVtr/Wk
Standard Error .044
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Population: Missing data due to nonattendance at lab visits
Assessed with skin conductance (SC; microsiemens, μS) in response to emotional cues presented in the lab (of note, per protocol, we examined DV in response to negative and neutral image stimuli \[Neg\] across initial \[Novel\] and repeated presentations) which were presented along with sound bursts to elicit startle. Data were transformed to address skew (μStr). Outcomes are reported as novel x negative slopes (SLP) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=25 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=25 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=25 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Emotional Habituation
|
-.156 Condition diff (NegxNovel) in Mn μStr/wk
Standard Error .07
|
.023 Condition diff (NegxNovel) in Mn μStr/wk
Standard Error .069
|
.134 Condition diff (NegxNovel) in Mn μStr/wk
Standard Error .076
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Assessed with skin conductance (SC; microsiemens, μS) in response to emotional scripts (Neg: neutral, negative) by emotion regulation (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Data were transformed to address skew (μStr). Outcomes are reported as slopes of Negative (Neg) condition effects on SC over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Physiological Emotional Reactivity
|
1.46 Condition diff (Neg) in Mean μS/week
Standard Error .48
|
-.71 Condition diff (Neg) in Mean μS/week
Standard Error .4
|
.41 Condition diff (Neg) in Mean μS/week
Standard Error .39
|
SECONDARY outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7Assessed with high frequency heart rate variability (HRV, ms2/hz) in response to emotional scripts (Negative: negative vs. neutral) with emotion regulation instructions (Reg: Maintain vs. Decrease in the Negative condition) presented in the lab. Data were transformed to address skew (ms2/hztr). Outcomes are reported as slopes of the effect of the Reg condition on HRV over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects /multilevel models.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Deliberate Physiological Emotional Regulation
|
.08 Condition diff (Reg) on Mn ms2/hztr/week
Standard Error .1
|
.10 Condition diff (Reg) on Mn ms2/hztr/week
Standard Error .10
|
.10 Condition diff (Reg) on Mn ms2/hztr/week
Standard Error .09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Assessed with the DBT-Ways of Coping Checklist (DBT-WCCL, transformed = DBTWCCLtr), which yields scales of skills use (DSS, rescaled \*100), general dysfunctional coping (DC1, rescaled \*10), and blaming others (DC2, \*10), with scores of 0-3, higher reflects greater use. Outcomes are reported as slopes (with SE) centered around treatment start per condition, extracted from mixed effects/multilevel models (separately per scale score).This measure is listed separately to permit presentation of two units of measure (that are in the same model) for the DC1 scale, which was fit best with a quadratic model, whereas the remaining scales only required a Linear model. This measure reflects the Linear measures (DBTWCCL/week) for all scales.
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Coping Strategies - Linear
DC1 - Linear - rescaled *10
|
-.17 DBTWCCLtr scores/week
Standard Error .08
|
-.31 DBTWCCLtr scores/week
Standard Error .07
|
-.26 DBTWCCLtr scores/week
Standard Error .07
|
|
Change in Coping Strategies - Linear
DSS - Linear ONLY - rescaled *100
|
.23 DBTWCCLtr scores/week
Standard Error .559
|
.546 DBTWCCLtr scores/week
Standard Error .523
|
.544 DBTWCCLtr scores/week
Standard Error .562
|
|
Change in Coping Strategies - Linear
DC2 - Linear ONLY- rescaled *10
|
-.174 DBTWCCLtr scores/week
Standard Error .079
|
-.230 DBTWCCLtr scores/week
Standard Error .074
|
-.219 DBTWCCLtr scores/week
Standard Error .080
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14Population: ITT sample
Assessed with the DBT-Ways of Coping Checklist (DBT-WCCL, transformed = DBTWCCLtr), which yields scales of skills use (DSS, rescaled \*100), general dysfunctional coping (DC1, rescaled \*10), and blaming others (DC2, \*10), with scores of 0-3, higher reflects greater use. Outcomes are reported as slopes (SE) centered around treatment start per condition, extracted from mixed effects/multilevel models (separately per scale score).This measure is listed separately to permit presentation of two units of measure (that are in the same model) for the DC1 scale, which was fit best with a quadratic model, whereas the remaining scales only required a Linear model. This measure reflects the Quadratic measure (DBTWCCL/week\^2).
Outcome measures
| Measure |
Dialectical Behavior Therapy - Emotion Regulation Skills Training
n=27 Participants
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training: Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
n=28 Participants
Dialectical behavior therapy - interpersonal effectiveness skills training
Dialectical behavior therapy - interpersonal effectiveness skills training: Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
|
Non-skills-oriented Interpersonal Psychotherapy Group
n=29 Participants
Non-skills-oriented interpersonal psychotherapy group
Interpersonal psychotherapy: Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
|
|---|---|---|---|
|
Change in Coping Strategies - Quad
|
-002 DBTWCCLtr DC1 scores/week^2
Standard Error .011
|
-.012 DBTWCCLtr DC1 scores/week^2
Standard Error .007
|
-.015 DBTWCCLtr DC1 scores/week^2
Standard Error .007
|
Adverse Events
Dialectical Behavior Therapy - Emotion Regulation Skills Training
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training
Non-skills-oriented Interpersonal Psychotherapy Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine Dixon-Gordon, PhD
University of Massachusetts Amherst
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place