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Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

Primary Purpose

Post-traumatic Stress Disorder, Suicide, Self-injurious Behavior

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Dialectical Behavior Therapy Prolonged Exposure protocol
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, Multi-diagnostic, Dialectical Behavior Therapy, Prolonged Exposure Therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Research and Therapy Clinics, University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dialectical Behavior Therapy

Dialectical Behavior Therapy + DBT Prolonged Exposure protocol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Global Severity of Illness
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.
Health-Related Quality of Life
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).
Therapist Adherence to the DBT PE Protocol
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.
Mental Health Treatment Utilization
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.
Intentional Self-Injury
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.

Full Information

First Posted
November 20, 2015
Last Updated
September 13, 2019
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02615197
Brief Title
Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
Official Title
Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Suicide, Self-injurious Behavior
Keywords
PTSD, Multi-diagnostic, Dialectical Behavior Therapy, Prolonged Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy
Arm Type
Active Comparator
Arm Description
Standard Dialectical Behavior Therapy (DBT) as described in the 2 DBT treatment manuals (Linehan, 1993; 2014).
Arm Title
Dialectical Behavior Therapy + DBT Prolonged Exposure protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Other Intervention Name(s)
DBT
Intervention Description
Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy Prolonged Exposure protocol
Other Intervention Name(s)
DBT PE
Intervention Description
Includes an adapted version of Prolonged Exposure therapy for PTSD.
Primary Outcome Measure Information:
Title
Change from Baseline PTSD Severity at 12 months
Description
The PTSD Symptom Scale - Interview will be used to measure the severity of the 17 DSM-IV PTSD symptoms.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Global Severity of Illness
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Health-Related Quality of Life
Description
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).
Time Frame
Baseline, 4, 8, and 12 months
Title
Therapist Adherence to the DBT PE Protocol
Description
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.
Time Frame
Two randomly selected DBT PE therapy sessions per client over the 12 months
Title
Mental Health Treatment Utilization
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Intentional Self-Injury
Description
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.
Time Frame
Baseline, 4, 8, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie S Harned, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Research and Therapy Clinics, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

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