NCT02615197

Brief Summary

The present project has two primary aims: (1) to examine the effectiveness of a multi-component implementation strategy in improving adoption and adherence to the Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol, and (2) to evaluate the feasibility, acceptability, and effectiveness of the DBT PE protocol in a sample of individuals receiving DBT in public mental health agencies. This study uses a hybrid type 2 effectiveness-implementation design to simultaneously test the clinical effectiveness of DBT + DBT PE and to evaluate an adaptive, multi-component implementation strategy. The effectiveness trial will use a quasi-experimental, controlled design to evaluate outcomes among DBT clients with PTSD who do versus do not receive the DBT PE protocol and outcomes will be benchmarked to those obtained in research settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

November 20, 2015

Last Update Submit

September 13, 2019

Conditions

Post-traumatic Stress DisorderSuicideSelf-injurious Behavior

Keywords

PTSDMulti-diagnosticDialectical Behavior TherapyProlonged Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline PTSD Severity at 12 months

    The PTSD Symptom Scale - Interview will be used to measure the severity of the 17 DSM-IV PTSD symptoms.

    Baseline to 12 months

Secondary Outcomes (5)

  • Global Severity of Illness

    Baseline, 4, 8, and 12 months

  • Health-Related Quality of Life

    Baseline, 4, 8, and 12 months

  • Therapist Adherence to the DBT PE Protocol

    Two randomly selected DBT PE therapy sessions per client over the 12 months

  • Mental Health Treatment Utilization

    Baseline, 4, 8, and 12 months

  • Intentional Self-Injury

    Baseline, 4, 8, and 12 months

Study Arms (2)

Dialectical Behavior Therapy

ACTIVE COMPARATOR

Standard Dialectical Behavior Therapy (DBT) as described in the 2 DBT treatment manuals (Linehan, 1993; 2014).

Behavioral: Dialectical Behavior Therapy

Dialectical Behavior Therapy + DBT Prolonged Exposure protocol

EXPERIMENTAL

Standard Dialectical Behavior Therapy (DBT) as described in the 2 DBT treatment manuals (Linehan, 1993; 2014) plus an adapted version of Prolonged Exposure therapy for PTSD.

Behavioral: Dialectical Behavior TherapyBehavioral: Dialectical Behavior Therapy Prolonged Exposure protocol

Interventions

Dialectical Behavior TherapyBEHAVIORAL

Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).

Also known as: DBT
Dialectical Behavior TherapyDialectical Behavior Therapy + DBT Prolonged Exposure protocol
Dialectical Behavior Therapy Prolonged Exposure protocolBEHAVIORAL

Includes an adapted version of Prolonged Exposure therapy for PTSD.

Also known as: DBT PE
Dialectical Behavior Therapy + DBT Prolonged Exposure protocol

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for PTSD
  • Currently receiving DBT individual therapy with a clinician enrolled in the study

You may not qualify if:

  • Not able to understand treatment and research assessments conducted in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Research and Therapy Clinics, University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSuicideSelf-Injurious Behavior

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melanie S Harned, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Psychology

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 26, 2015

Study Start

February 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

US(1)