Comparative effectiveness of trauma-focused and non-trauma-focused psychotherapy for PTSD among veterans with comorbid substance use disorders: Protocol & rationale for a randomized clinical trial.


Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
09 2022
Historique:
received: 03 06 2022
revised: 28 07 2022
accepted: 04 08 2022
pubmed: 21 8 2022
medline: 24 9 2022
entrez: 20 8 2022
Statut: ppublish

Résumé

Co-occurrence of posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) is common and concurrent treatment is recommended. Relatively little is known about which evidence-based psychotherapies for PTSD are most effective for patients with varying substance use profiles. We aim to examine the comparative effectiveness of trauma-focused therapy (TFT) and non-trauma-focused therapy (NTFT) among Veterans with PTSD and SUD. TFT has been found to be effective among those with PTSD/SUD, though effects are smaller and rates of treatment non-completion are higher than in those without SUD. NTFTs suggested for the treatment of PTSD, such as Present Centered Therapy, (PCT) have not been examined among those with co-occurring SUD, despite lower rates of treatment dropout. We will also examine the comparative effectiveness of TFT and NTFT for patients with varying SUD severity, type of substances used, and patient treatment preference. 420 Veterans with PTSD and SUD will be randomized in a prospective, pragmatic comparative effectiveness trial at 14 Veterans Health Administration facilities. Participants will receive either TFT (Prolonged Exposure or Cognitive Processing Therapy) or NTFT (PCT) after enrolling in concurrent SUD treatment-as-usual. Assessments will occur at baseline, posttreatment, 3- and 6 -months posttreatment. Main outcomes are PTSD symptom severity and PTSD treatment dropout. Clinician, patient, and leadership stakeholder panels advise study activities, and a process evaluation will identify strategies to enhance the implementation of evidence-based PTSD treatments in SUD care settings. Results will provide critical information to guide clinicians when recommending PTSD treatments to patients with comorbid SUD. gov Identifier: NCT04581434.

Sections du résumé

BACKGROUND
Co-occurrence of posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) is common and concurrent treatment is recommended. Relatively little is known about which evidence-based psychotherapies for PTSD are most effective for patients with varying substance use profiles. We aim to examine the comparative effectiveness of trauma-focused therapy (TFT) and non-trauma-focused therapy (NTFT) among Veterans with PTSD and SUD. TFT has been found to be effective among those with PTSD/SUD, though effects are smaller and rates of treatment non-completion are higher than in those without SUD. NTFTs suggested for the treatment of PTSD, such as Present Centered Therapy, (PCT) have not been examined among those with co-occurring SUD, despite lower rates of treatment dropout. We will also examine the comparative effectiveness of TFT and NTFT for patients with varying SUD severity, type of substances used, and patient treatment preference.
METHOD
420 Veterans with PTSD and SUD will be randomized in a prospective, pragmatic comparative effectiveness trial at 14 Veterans Health Administration facilities. Participants will receive either TFT (Prolonged Exposure or Cognitive Processing Therapy) or NTFT (PCT) after enrolling in concurrent SUD treatment-as-usual. Assessments will occur at baseline, posttreatment, 3- and 6 -months posttreatment. Main outcomes are PTSD symptom severity and PTSD treatment dropout. Clinician, patient, and leadership stakeholder panels advise study activities, and a process evaluation will identify strategies to enhance the implementation of evidence-based PTSD treatments in SUD care settings.
CONCLUSIONS
Results will provide critical information to guide clinicians when recommending PTSD treatments to patients with comorbid SUD.
CLINICALTRIALS
gov Identifier: NCT04581434.

Identifiants

pubmed: 35987487
pii: S1551-7144(22)00202-6
doi: 10.1016/j.cct.2022.106876
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04581434']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

106876

Informations de copyright

Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Shannon M Kehle-Forbes (SM)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Women's Health Sciences Division at VA Boston, National Center for PTSD, 150 S. Huntington Ave, Boston, MA 02130, United States of America; Department of Medicine, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, United States of America. Electronic address: Shannon.Kehle-Forbes@va.gov.

David Nelson (D)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Department of Medicine, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, United States of America.

Sonya B Norman (SB)

National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, University of California San Diego, 3350 La Jolla Village Drive, La Jolla, CA 92161, United States of America.

Paula P Schnurr (PP)

National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, NH 03577, United States of America.

M Tracie Shea (MT)

Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI 02906, United States of America.

Princess E Ackland (PE)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Department of Medicine, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, United States of America.

Laura Meis (L)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Department of Medicine, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, United States of America.

Kyle Possemato (K)

VA Center for Integrated Healthcare, 800 Irving Avenue, Syracuse, NY 13204, United States of America.

Melissa A Polusny (MA)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Department of Psychiatry & Behavioral Sciences, University of Minnesota Medical School, 2312 South 6(th) Street, Minneapolis, MN 55454, United States of America.

David Oslin (D)

VISN 4 MIRECC, Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States of America; Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 1 191049, United States of America.

Jessica L Hamblen (JL)

National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, NH 03577, United States of America.

Tara Galovski (T)

Women's Health Sciences Division at VA Boston, National Center for PTSD, 150 S. Huntington Ave, Boston, MA 02130, United States of America; Department of Psychiatry, Boston University, Boston, MA 02118, United States of America.

Marie Kenny (M)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America.

Nofisat Babajide (N)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America.

Hildi Hagedorn (H)

Center for Care Delivery & Outcomes Research, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States of America; Department of Psychiatry & Behavioral Sciences, University of Minnesota Medical School, 2312 South 6(th) Street, Minneapolis, MN 55454, United States of America.

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