Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial.
Acupuncture
Combat
Post-traumatic stress
Psychophysiology
Veterans
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Sep 2021
06 Sep 2021
Historique:
received:
14
11
2020
accepted:
23
06
2021
entrez:
7
9
2021
pubmed:
8
9
2021
medline:
9
9
2021
Statut:
epublish
Résumé
Post-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13-18% of the combat Veteran population. The first study using acupuncture for PTSD in a civilian population showed large pre- to post-treatment effects for an empirically developed verum protocol, which was equivalent to group cognitive behavior therapy and superior to a wait-list control. The primary objective of this study is to determine both clinical and biological effects of verum acupuncture for combat-related PTSD in treatment-seeking US Veterans. This is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial. The experimental condition is verum acupuncture and the placebo control is sham (minimal) acupuncture in 1-h sessions, twice a week for 12 weeks. Ninety subjects will provide adequate power and will be allocated to group by an adaptive randomization procedure. The primary outcome is change in PTSD symptom severity from pre- to post-treatment. The secondary biological outcome is change from pre- to post-treatment in psychophysiological response, startle by electromyographic (EMG) eyeblink. Assessments will be conducted at pre-, mid-, post-, and 1-month post-treatment, blind to group allocation. Intent-to-treat analyses will be conducted. The study results will be definitive because both clinical and biological outcomes will be assessed and correlated. Issues such as the number needed for recruitment and improvement, use of sham acupuncture, choice of biological measure, and future research need will be discussed. ClinicalTrials.gov NCT02869646 . Registered on 17 August 2016.
Sections du résumé
BACKGROUND
BACKGROUND
Post-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13-18% of the combat Veteran population. The first study using acupuncture for PTSD in a civilian population showed large pre- to post-treatment effects for an empirically developed verum protocol, which was equivalent to group cognitive behavior therapy and superior to a wait-list control. The primary objective of this study is to determine both clinical and biological effects of verum acupuncture for combat-related PTSD in treatment-seeking US Veterans.
METHODS
METHODS
This is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial. The experimental condition is verum acupuncture and the placebo control is sham (minimal) acupuncture in 1-h sessions, twice a week for 12 weeks. Ninety subjects will provide adequate power and will be allocated to group by an adaptive randomization procedure. The primary outcome is change in PTSD symptom severity from pre- to post-treatment. The secondary biological outcome is change from pre- to post-treatment in psychophysiological response, startle by electromyographic (EMG) eyeblink. Assessments will be conducted at pre-, mid-, post-, and 1-month post-treatment, blind to group allocation. Intent-to-treat analyses will be conducted.
DISCUSSION
CONCLUSIONS
The study results will be definitive because both clinical and biological outcomes will be assessed and correlated. Issues such as the number needed for recruitment and improvement, use of sham acupuncture, choice of biological measure, and future research need will be discussed.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02869646 . Registered on 17 August 2016.
Identifiants
pubmed: 34488824
doi: 10.1186/s13063-021-05394-3
pii: 10.1186/s13063-021-05394-3
pmc: PMC8419889
doi:
Banques de données
ClinicalTrials.gov
['NCT02869646']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
594Subventions
Organisme : CSRD VA
ID : I01 CX001416
Pays : United States
Organisme : Clinical Sciences Research and Development - VA Office of Research and Development
ID : CX-15-006
Informations de copyright
© 2021. The Author(s).
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