Academic Journal
Evaluating psychotherapies for veterans with PTSD at elevated acute risk of suicide: Protocol for a multi-site type 1 hybrid effectiveness-implementation trial.
| Τίτλος: | Evaluating psychotherapies for veterans with PTSD at elevated acute risk of suicide: Protocol for a multi-site type 1 hybrid effectiveness-implementation trial. |
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| Συγγραφείς: | Harned MS; VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, USA; Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific Street, Seattle, WA, USA. Electronic address: melanie.harned@va.gov., Ready CB; Durham VA Health Care System, 508 Fulton Street, Durham, NC, USA., Andrews Wiebusch LM; Minneapolis VA Health Care System, 1 Veterans Drive, Minneapolis, MN, USA., Landes SJ; Behavioral Health Quality Enhancement Research Initiative (QUERI), Central Arkansas Veterans Healthcare System, 2200 Fort Roots Drive, North Little Rock, AR, USA; Department of Psychiatry, University of Arkansas for Medical Sciences, 4224 Shuffield Drive, Little Rock, AR, USA., Blalock DV; Durham VA Health Care System, 508 Fulton Street, Durham, NC, USA; Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, 411 W Chapel Hill Street, Durham, NC, USA; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, 2400 Pratt Street, Durham, NC, USA., Waddell ZE; VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, USA., Carter JM; South Texas VA Health Care System, 7400 Merton Minter, San Antonio, TX, USA., Hembree EA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, USA., Meis LA; Minneapolis VA Health Care System, 1 Veterans Drive, Minneapolis, MN, USA; National Center for PTSD, Women's Health Sciences Division, 150 South Huntington Street, Boston, MA, USA; Center for Care Delivery and Outcomes Research, Minneapolis, VA Healthcare System, 1 Veterans Drive (152), Minneapolis, MN, USA; Department of Medicine, University of Minnesota Medical School, 420 Delaware Street SE, MMC 194, Suite 14-110 Phillips-Wangensteen Building, Minneapolis, MN, USA. |
| Πηγή: | Contemporary clinical trials [Contemp Clin Trials] 2026 Oct; Vol. 169, pp. 108433. Date of Electronic Publication: 2026 Aug 15. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial Protocol |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, N.Y. : Elsevier, c2005- |
| Ιατρικοί όροι (MeSH): | Stress Disorders, Post-Traumatic*/therapy , Stress Disorders, Post-Traumatic*/psychology , Veterans*/psychology , Implosive Therapy*/methods , Dialectical Behavior Therapy*/methods , Suicide Prevention*, Suicide/psychology ; Affective Symptoms/therapy ; Humans ; United States ; Multicenter Studies as Topic ; Suicidal Ideation ; Randomized Controlled Trials as Topic ; United States Department of Veterans Affairs |
| Περίληψη: | Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among veterans, but there is a critical knowledge gap about how to treat PTSD in the context of elevated acute suicide risk. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) reduces PTSD and self-directed violence (SDV) among high-risk individuals while also being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial is needed. This study will compare the effectiveness of DBT + DBT PE to the current gold standard of care in the Veterans Health Administration (VHA), Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining barriers and facilitators to implementing these treatments in VHA. Methods: This multi-site hybrid type 1 effectiveness-implementation trial will randomize 125 veterans with PTSD, recent and repeated SDV, suicidal ideation, and emotion dysregulation to DBT + DBT PE (12 months) or PE + SRM (up to 20 weeks). Participants will be treated at 4 VHA sites and evaluated by masked assessors at 5 points over 16 months. Implementation determinants will be assessed among veterans, providers, and administrators using a mixed methods approach. Results: The project is ongoing and results will be reported in future manuscripts. Conclusion: This project will yield generalizable knowledge about how to safely and effectively treat PTSD among individuals at elevated acute risk of suicide as well as how to maximize future implementation success if either treatment is found effective. Trial Registration: ClinicalTrials.govNCT05974631, date of registration July 25, 2023, https://clinicaltrials.gov/study/NCT05974631. (Published by Elsevier Inc.) |
| Competing Interests: | Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Harned is paid to provide training and consultation in DBT and DBT PE; receives royalties from Guilford Press for the DBT PE manual; receives royalties from Psychwire for the online course Applied DBT Skills for Trauma. Dr. Landes is paid to provide consultation for implementation research. Dr. Blalock receives consulting fees from Eating Recovery Center/Pathlight Mood and Anxiety Centers. Dr. Hembree receives royalties from Oxford University Press for the PE Therapist Guide and accompanying client workbook; is paid to provide training and consultation in PE. |
| Contributed Indexing: | Keywords: DBT Prolonged Exposure protocol; Dialectical Behavior Therapy; Hybrid type 1 effectiveness-implementation RCT; Posttraumatic stress disorder; Prolonged Exposure therapy; Suicide prevention; Veterans health administration |
| Molecular Sequence: | ClinicalTrials.gov NCT05974631 |
| Entry Date(s): | Date Created: 20260815 Date Completed: 20260912 Latest Revision: 20260923 |
| Update Code: | 20260924 |
| DOI: | 10.1016/j.cct.2026.108433 |
| PMID: | 42603614 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1559-2030 |
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| DOI: | 10.1016/j.cct.2026.108433 |