Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
08 06 2021
Historique:
entrez: 9 6 2021
pubmed: 10 6 2021
medline: 22 6 2021
Statut: epublish

Résumé

As many as 74% of veterans with alcohol use disorders (AUDS) report symptoms of insomnia. Insomnia represents a barrier to alcohol treatment because insomnia symptoms (1) may lead to relapse among those who use alcohol to help them sleep and may negatively impact (2) executive functions and (3) emotion regulation skills. Cognitive-behavioural therapy for insomnia (CBT-I) is an efficacious first-line treatment for insomnia; however, no research has examined the impact of CBT-I on individuals' response to alcohol treatment. In the Sleep and Alcohol for Veterans (Project SAVE) randomised controlled trial, we hypothesise that CBT-I will enhance the efficacy of alcohol treatment among Veterans with insomnia by enhancing their abilities to attend to treatment, regulate emotions and initiate sleep without alcohol. Eighty Veterans enrolled in alcohol treatment at the Veterans Administration (VA) hospital will be randomly assigned to receive either CBT-I or single-session sleep hygiene (SH) education. Individuals will be eligible to participate if they meet Ethics approval was obtained in October 2018. Data collection began in July 2019 and is planned for completion by July 2021. Trial results will be disseminated at local and national conferences, in peer-reviewed publications and through media outlets, as available. Results will also be shared with interested participants and clinical collaborators at the end of the trial. clinicaltrials.gov identifier NCT03806491 (pre-results).

Identifiants

pubmed: 34103317
pii: bmjopen-2020-045667
doi: 10.1136/bmjopen-2020-045667
pmc: PMC8190049
doi:

Banques de données

ClinicalTrials.gov
['NCT03806491']

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e045667

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Mary Beth Miller (MB)

Department of Psychiatry, University of Missouri, Columbia, MO, USA millmary@health.missouri.edu.

Jane Metrik (J)

Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA.
Mental Health & Behavioral Sciences Service, Providence VA Medical Center, Providence, RI, USA.

John E McGeary (JE)

Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA.
Mental Health & Behavioral Sciences Service, Providence VA Medical Center, Providence, RI, USA.

Brian Borsari (B)

Mental Health Service, San Francisco VA Health Care System, San Francisco, CA, USA.
Department of Psychiatry and Behavioral Services, University of California San Francisco, San Francisco, CA, USA.

Christina S McCrae (CS)

Department of Psychiatry, University of Missouri, Columbia, MO, USA.

John Maddoux (J)

Harry S Truman Memorial Veterans' Hospital, Columbia, Missouri, USA.

J Todd Arnedt (JT)

Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.

Jennifer E Merrill (JE)

Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA.

Kate B Carey (KB)

Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA.

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