NCT04626310: MAP-DBT

Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

Completed NA Results posted Last updated 27 November 2024

What this trial tests

NA trial testing Dialectical behavior therapy - emotion regulation skills training in Borderline Personality Disorder in 84 participants. Completed in 6 February 2023.

Timeline

26 October 2020

Primary endpoint
6 February 2023

6 February 2023

Quick facts

Lead sponsor	University of Massachusetts, Amherst
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	84
Start date	26 October 2020
Primary completion	6 February 2023
Estimated completion	6 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Dialectical behavior therapy - emotion regulation skills training
• Dialectical behavior therapy - interpersonal effectiveness skills training
• Interpersonal psychotherapy

Conditions studied

• Borderline Personality Disorder — all drugs for Borderline Personality Disorder →

Sponsor

University of Massachusetts, Amherst

Who can join

Adults 18 to 60, any sex, with Borderline Personality Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Emotional Functioning - Linear Primary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.917	± .31
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-1.25	± .32
Non-skills-oriented Interpersonal Psychotherapy Group	-1.01	± .26

Change in Borderline Personality Disorder Features - Linear Primary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-1.716	± .808
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-3.567	± .746
Non-skills-oriented Interpersonal Psychotherapy Group	-3.667	± .833

Change in Self-reported Emotional Reactivity Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.07	± .06
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.09	± .06
Non-skills-oriented Interpersonal Psychotherapy Group	-.12	± .06

Change in Self-reported Emotional Regulation Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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 effe

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.18	± .07
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.01	± .07
Non-skills-oriented Interpersonal Psychotherapy Group	.15	± .07

Change in Affect-modulated Startle Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	.015	± .041
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	.043	± .040
Non-skills-oriented Interpersonal Psychotherapy Group	-.076	± .044

Change in Emotional Habituation Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.156	± .07
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	.023	± .069
Non-skills-oriented Interpersonal Psychotherapy Group	.134	± .076

Change in Physiological Emotional Reactivity Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	1.46	± .48
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.71	± .4
Non-skills-oriented Interpersonal Psychotherapy Group	.41	± .39

Change in Deliberate Physiological Emotional Regulation Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	.08	± .1
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	.10	± .10
Non-skills-oriented Interpersonal Psychotherapy Group	.10	± .09

Change in Coping Strategies - Linear Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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 quadrat

DSS - Linear ONLY - rescaled *100

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	.23	± .559
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	.546	± .523
Non-skills-oriented Interpersonal Psychotherapy Group	.544	± .562

DC1 - Linear - rescaled *10

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.17	± .08
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.31	± .07
Non-skills-oriented Interpersonal Psychotherapy Group	-.26	± .07

DC2 - Linear ONLY- rescaled *10

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.174	± .079
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.230	± .074
Non-skills-oriented Interpersonal Psychotherapy Group	-.219	± .080

Change in Emotional Functioning - Quad Primary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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.

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.06	± .04
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.04	± .04
Non-skills-oriented Interpersonal Psychotherapy Group	-.07	± .03

Change in Borderline Personality Disorder Features - Quad Primary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-.162	± .108
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.163	± .095
Non-skills-oriented Interpersonal Psychotherapy Group	-.135	± .100

Change in Coping Strategies - Quad Secondary · Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

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 mo

Group	Value	95% CI
Dialectical Behavior Therapy - Emotion Regulation Skills Training	-002	± .011
Dialectical Behavior Therapy - Interpersonal Effectiveness Skills Training	-.012	± .007
Non-skills-oriented Interpersonal Psychotherapy Group	-.015	± .007

Sponsor's own description

Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. This study compares the unique effects of two distinct DBT skills training modules, relative to a non-DBT therapy group for adults with borderline personality disorder. Using innovative laboratory-based assessment methods, the proposed study will examine the effects of these conditions on emotional responding and interpersonal functioning, as well as clinical outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.