Mapping Aspects of Psychotherapy in Dialectical Behavior... | NCT04626310

ID	Type	Description	Link
R21MH119530-01A1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Mental Health (NIMH)	NIH
University of Toledo	OTHER

Description Module

Detailed Description

Borderline personality disorder (BPD) is a severe mental health condition with high morbidity and mortality. Although dialectical behavior therapy (DBT) is an efficacious treatment for BPD, it is resource-intensive and lengthy in its full form, involving one year of weekly individual therapy and group skills training in mindfulness, emotion regulation, interpersonal effectiveness, and distress tolerance. As a result, few patients have access to the full treatment. A better understanding of how the distinct components of DBT affect different sets of symptoms could help to streamline this treatment and personalize its use with specific patients.

Improvements in both interpersonal and emotional functioning are theorized to underlie improvements in BPD. Thus, emotion regulation and interpersonal effectiveness skills training may be particularly important components of DBT. Therefore, this study examines the unique effects of two distinct DBT skills training modules.

Participants are adults with BPD and recent, recurrent self-injurious behaviors (planned N = 81) who are randomly assigned to six weeks of DBT emotion regulation skills training (DBT-ER), DBT interpersonal effectiveness skills training (DBT-IE), or a non-skills control group. Using innovative laboratory-based multimethod assessments, this study examines the effects of these conditions on emotional responding and interpersonal functioning, as well as BPD related outcomes. Aim 1 examines the unique effects of DBT-ER and DBT-IE on their respective emotion-related (subjective and biological emotional reactivity, behavioral emotion regulation, skills use) and interpersonal (subjective and behavioral) targets, compared to the non-DBT treatment. Aim 2 examines whether improved emotional functioning predicts reductions in BPD symptoms and self-injury. Aim 3 examines whether baseline emotion dysregulation interacts with treatment condition to predict treatment response.

The proposed research is innovative in its experimental examination of the effects of DBT components on specific targets in BPD. Given the high societal costs of BPD, this work has important public health significance. Findings will inform larger studies evaluating the potential modular use of DBT components to result in briefer and more efficient individualized treatments for patients.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dialectical behavior therapy - emotion regulation skills training	Experimental	Dialectical behavior therapy - emotion regulation skills training	Behavioral: Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - interpersonal effectiveness skills training	Experimental	Dialectical behavior therapy - interpersonal effectiveness skills training	Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training
Non-skills-oriented interpersonal psychotherapy group	Active Comparator	Non-skills-oriented interpersonal psychotherapy group	Behavioral: Interpersonal psychotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dialectical behavior therapy - emotion regulation skills training	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Emotional Functioning - Linear	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.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Borderline Personality Disorder Features - Linear	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.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Emotional Functioning - Quad	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.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

Secondary Outcomes

Measure	Description	Time Frame
Change in Self-reported Emotional Reactivity	Assessed 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.

Other Outcomes

Measure	Description	Time Frame
Change in Coping Strategies - Linear	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 (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.

Eligibility Module

Name	Affiliation	Role
Katherine L Dixon-Gordon, PhD	University of Massachusetts, Amherst	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Psychological Services Center, University of Massachusetts Amherst		Amherst	Massachusetts	01002	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 1, 2024

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00027 BG00128 BG00229 BG00384

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00026.41± 11.71 BG00125.75± 9.95 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00024 BG00126 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00027 BG00128 BG002

DERS total

Means are provided separately for DBT-ER (n = 27), DBT-IE (n = 28), and interpersonal psychotherapy (n = 29)

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG000118.525± 23.707 BG001116.539± 21.399

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Emotional Functioning - Linear

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.

ITT sample (see study description)

Posted

Mean

Standard Error

DERS scores/wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00027 OG00128 OG00229

Title

Denominators

Categories

Title	Measurements
	OG000-.917± .31 OG001-1.25± .32 OG002-1.01± .26

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.	Mixed Models Analysis		.8		Linear slope difference DBT-ER-IP	.096	Standard Error of the Mean	.08	2-Sided								Superiority
OG001 OG002

Primary

Change in Borderline Personality Disorder Features - Linear

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.

missing 1 data point for DBT-ER group

Posted

Mean

Standard Error

BSL scores/wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.
OG001

Secondary

Change in Self-reported Emotional Reactivity

Assessed 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.

Posted

Mean

Standard Error

Condition diff (Neg-Neu) in NA scores/wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.
OG001	Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training

Secondary

Change in Self-reported Emotional Regulation

Assessed 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.

Posted

Mean

Standard Error

Condition diff (Reg) in NA score/wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.
OG001	Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training

Secondary

Change in Affect-modulated Startle

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.

Some participants were missing data due to nonattendance at lab sessions

Posted

Mean

Standard Error

Condition diff (NegXNovel) in Mn mVtr/Wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.

Secondary

Change in Emotional Habituation

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.

Missing data due to nonattendance at lab visits

Posted

Mean

Standard Error

Condition diff (NegxNovel) in Mn μStr/wk

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.
OG001	Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training

Secondary

Change in Physiological Emotional Reactivity

Assessed 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.

Posted

Mean

Standard Error

Condition diff (Neg) in Mean μS/week

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.
OG001	Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training

Secondary

Change in Deliberate Physiological Emotional Regulation

Assessed 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.

Posted

Mean

Standard Error

Condition diff (Reg) on Mn ms2/hztr/week

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

ID	Title	Description
OG000	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.
OG001	Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training

Other Pre-specified

Change in Coping Strategies - Linear

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 (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.

Posted

Mean

Standard Error

DBTWCCLtr scores/week

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.

Primary

Change in Emotional Functioning - Quad

ITT sample (see study description)

Posted

Mean

Standard Error

DERS scores/wk^2

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.
OG001

Primary

Change in Borderline Personality Disorder Features - Quad

missing 1 data point for DBT-ER group from ITT sample

Posted

Mean

Standard Error

BSL scores/wk^2

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.
OG001

Other Pre-specified

Change in Coping Strategies - Quad

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).

ITT sample

Posted

Mean

Standard Error

DBTWCCLtr DC1 scores/week^2

Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

ID	Title	Description
OG000	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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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.	27	27	27
EG001	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.	28	28	28
EG002	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.	29	29	29

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities