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Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

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ClinicalTrials.gov Identifier: NCT02615197
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Melanie Harned, University of Washington

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Suicide Self-injurious Behavior Behavioral: Dialectical Behavior Therapy Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
Actual Study Start Date : February 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
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 Name: 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 Name: DBT

Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol
Includes an adapted version of Prolonged Exposure therapy for PTSD.
Other Name: DBT PE




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615197


Locations
United States, Washington
Behavioral Research and Therapy Clinics, University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Melanie S Harned, PhD University of Washington

Responsible Party: Melanie Harned, Research Scientist, Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT02615197     History of Changes
Other Study ID Numbers: 49013
R34MH106598 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Melanie Harned, University of Washington:
PTSD
Multi-diagnostic
Dialectical Behavior Therapy
Prolonged Exposure Therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Suicide
Self-Injurious Behavior
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms