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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

November 20, 2015
November 26, 2015
April 20, 2018
February 2016
March 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02615197 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Post-traumatic Stress Disorder
  • Suicide
  • Self-injurious Behavior
  • 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
  • Active Comparator: Dialectical Behavior Therapy
    Standard Dialectical Behavior Therapy (DBT) as described in the 2 DBT treatment manuals (Linehan, 1993; 2014).
    Intervention: Behavioral: Dialectical Behavior Therapy
  • 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.
    Interventions:
    • Behavioral: Dialectical Behavior Therapy
    • Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
75
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02615197
49013
R34MH106598 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Melanie Harned, University of Washington
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Melanie S Harned, PhD University of Washington
University of Washington
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP