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Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02615197
Enrollment
35
Registered
2015-11-26
Start date
2016-02-29
Completion date
2019-03-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PTSD, Multi-diagnostic, Dialectical Behavior Therapy, Prolonged Exposure Therapy

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.

Interventions

BEHAVIORALDialectical Behavior Therapy

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

Includes an adapted version of Prolonged Exposure therapy for PTSD.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline PTSD Severity at 12 monthsBaseline to 12 monthsThe PTSD Symptom Scale - Interview will be used to measure the severity of the 17 DSM-IV PTSD symptoms.

Secondary

MeasureTime frameDescription
Global Severity of IllnessBaseline, 4, 8, and 12 monthsThe 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 LifeBaseline, 4, 8, and 12 monthsThe 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 ProtocolTwo randomly selected DBT PE therapy sessions per client over the 12 monthsThe 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 UtilizationBaseline, 4, 8, and 12 monthsThe 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-InjuryBaseline, 4, 8, and 12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026