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Completed

NCT Number: NCT02615197

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Behavioral Research and Therapy Clinics, University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical behavior therapy

Behavioral

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

Other names: DBT

Dialectical Behavior Therapy Prolonged Exposure protocol

Behavioral

Includes an adapted version of Prolonged Exposure therapy for PTSD.

Other names: DBT PE

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2015
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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