Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

September 13, 2019 updated by: Melanie Harned, University of Washington
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although several evidence-based treatments (EBTs) for post-traumatic stress disorder (PTSD) have been found to be effective in research and community settings, individuals with PTSD who are acutely suicidal, self-injuring, and/or have severe comorbid disorders are typically excluded from these treatments. The Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol has been shown to be effective in treating PTSD among suicidal, self-injuring, and multi-diagnostic individuals receiving Dialectical Behavior Therapy (DBT) in research settings. 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 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. The project will be conducted in collaboration with Philadelphia's Department of Behavioral Health and Intellectual disAbility Services (DBHIDS). 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. Clinical effectiveness outcomes include measures of PTSD, suicidality, global symptom severity, and quality of life and will be assessed at four timepoints (baseline, 4, 8, and 12 months) using blinded independent evaluators. The initial implementation strategy will include an implementation team, online training, distribution of a treatment manual, in-person workshop, team-based clinical consultation, and audit and feedback on session content. The implementation strategy will be adapted as needed during the project using Plan-Do-Study-Act quality improvement methods. Implementation outcomes include feasibility, acceptability, adoption, fidelity, penetration, and sustainability of the DBT PE protocol and will be assessed via clinician surveys at 8 timepoints over 2 years (baseline, pre-training, post-training, 4, 8, and 12-months after initial training during active implementation, and 6 and 12 months follow-up after implementation is complete). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative evaluation (e.g., surveys and interviews with clients, clinicians, and agency administrators). Four public mental health agencies with existing DBT programs will be recruited for participation. It is estimated that this will yield a sample of 25 clinicians who will enroll a maximum of 3 clients each in the effectiveness trial (n=75 clients total). The project will also engage an advisory board of stakeholders in the DBHIDS system.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Behavioral Research and Therapy Clinics, University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dialectical Behavior Therapy
Standard Dialectical Behavior Therapy (DBT) as described in the 2 DBT treatment manuals (Linehan, 1993; 2014).
Behavioral: Dialectical Behavior Therapy
Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Other Names:
  • DBT
Experimental: Dialectical Behavior Therapy + DBT Prolonged Exposure protocol
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 Therapy
Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Other Names:
  • DBT
Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol
Includes an adapted version of Prolonged Exposure therapy for PTSD.
Other Names:
  • DBT PE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline PTSD Severity at 12 months
Time Frame: Baseline to 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Severity of Illness
Time Frame: Baseline, 4, 8, and 12 months
The self-report Brief Symptom Inventory will be used to calculate the Global Severity Index (GSI), which quantifies the patient's overall severity-of-illness.
Baseline, 4, 8, and 12 months
Health-Related Quality of Life
Time Frame: Baseline, 4, 8, and 12 months
The self-report CDC Health-Related Quality of Life-4 will be used to assess the number of recent healthy days (i.e., a summary measure of a person's physically and mentally healthy days).
Baseline, 4, 8, and 12 months
Therapist Adherence to the DBT PE Protocol
Time Frame: Two randomly selected DBT PE therapy sessions per client over the 12 months
The DBT PE Adherence Scale will be used is an observer-rated measure of the therapist's adherence to the DBT PE protocol during actual therapy sessions.
Two randomly selected DBT PE therapy sessions per client over the 12 months
Mental Health Treatment Utilization
Time Frame: Baseline, 4, 8, and 12 months
The structured Treatment History Interview will be used to assess utilization of various mental health services (e.g., psychotherapy, psychiatric hospitalization) as well as psychotropic medications.
Baseline, 4, 8, and 12 months
Intentional Self-Injury
Time Frame: Baseline, 4, 8, and 12 months
The structured Suicide Attempt Self-Injury Interview will be used to measure the method, intent, medical severity, and outcomes of suicidal and non-suicidal self-injurious behavior.
Baseline, 4, 8, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melanie S Harned, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49013
  • R34MH106598 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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