Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

NCT ID: NCT02615197

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-03-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dialectical Behavior Therapy

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

Group Type: ACTIVE_COMPARATOR

Dialectical Behavior Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy

Intervention Type: BEHAVIORAL

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

Dialectical Behavior Therapy Prolonged Exposure protocol

Intervention Type: BEHAVIORAL

Includes an adapted version of Prolonged Exposure therapy for PTSD.

Interventions

Dialectical Behavior Therapy

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

Intervention Type: BEHAVIORAL

Dialectical Behavior Therapy Prolonged Exposure protocol

Includes an adapted version of Prolonged Exposure therapy for PTSD.

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT; DBT PE

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Melanie Harned

Research Scientist, Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie S Harned, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Behavioral Research and Therapy Clinics, University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

R34MH106598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

49013

Identifier Type: -

Identifier Source: org_study_id