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Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

ABSTRACT: Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial.The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012.This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people.ClinicalTrials.gov Identifier NCT00671099.

SUBMITTER: Matsuoka Y

PROVIDER: S-EPMC3598223 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

Matsuoka Yutaka Y Nishi Daisuke D Yonemoto Naohiro N Hamazaki Kei K Matsumura Kenta K Noguchi Hiroko H Hashimoto Kenji K Hamazaki Tomohito T

BMC psychiatry 20130105

<h4>Background</h4>Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the ...[more]

PMID: 23289548

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Project description:BackgroundA small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma. There is relatively little data, however, on the use of selective serotonin reuptake inhibitors (SSRIs) in this context.Methods24 week, double-blind placebo controlled study. 31 participants presenting immediately after trauma, and meeting diagnostic criteria for full or partial acute stress disorder were randomized to treatment with 10-20 mg of escitalopram or placebo daily for 24 weeks. 2 participants were excluded from the analysis due to early drop out, leaving 29 participants (escitalopram = 12, placebo = 17) for inclusion in an intent- to- treat analysis. Participants were followed up until 56 weeks, and assessed with the Clinician Administered PTSD Scale (CAPS). A mixed model repeated measures analysis of variance (RMANOVA) was undertaken to determine the efficacy of the intervention on the CAPS score.ResultsThere was a significant reduction in CAPS score over the course of treatment (F(7, 142) = 41. 58, p < 0.001) in both the escitalopram and placebo groups, with a greater reduction in CAPS score in the placebo group F(7, 142) = 2.12, p = 0.045. There were improvements on all secondary measures, including the Clinical Global Impressions scale, and scales assessing depression, anxiety and disability. Only functional disability outcomes (F(7, 141) = 2.13, p = .04), were significantly different between treatment and placebo groups. In the sample as a whole, improvement in scores were maintained at the 52 week follow-up. Side effects were comparable between the groups.ConclusionsThese data are consistent with other recent work indicating that the SSRIs may not be efficacious in the prevention of PTSD. Nevertheless, the small sample size and baseline differences between groups limit the explanatory power of the study. Although a consideration of the possibility of medication prophylaxis in PTSD remains important, both from conceptual and clinical perspectives, caution is needed with regards to the use of SSRIs until their efficacy can be proven.Trial registrationClinical Trials NCT00300313.

Project description:IMPORTANCE:The role of ?-3 polyunsaturated fatty acids for primary prevention of coronary heart disease (CHD) remains controversial. Most prior longitudinal studies evaluated self-reported consumption rather than biomarkers. OBJECTIVE:To evaluate biomarkers of seafood-derived eicosapentaenoic acid (EPA; 20:5?-3), docosapentaenoic acid (DPA; 22:5?-3), and docosahexaenoic acid (DHA; 22:6?-3) and plant-derived ?-linolenic acid (ALA; 18:3?-3) for incident CHD. DATA SOURCES:A global consortium of 19 studies identified by November 2014. STUDY SELECTION:Available prospective (cohort, nested case-control) or retrospective studies with circulating or tissue ?-3 biomarkers and ascertained CHD. DATA EXTRACTION AND SYNTHESIS:Each study conducted standardized, individual-level analysis using harmonized models, exposures, outcomes, and covariates. Findings were centrally pooled using random-effects meta-analysis. Heterogeneity was examined by age, sex, race, diabetes, statins, aspirin, ?-6 levels, and FADS desaturase genes. MAIN OUTCOMES AND MEASURES:Incident total CHD, fatal CHD, and nonfatal myocardial infarction (MI). RESULTS:The 19 studies comprised 16 countries, 45?637 unique individuals, and 7973 total CHD, 2781 fatal CHD, and 7157 nonfatal MI events, with ?-3 measures in total plasma, phospholipids, cholesterol esters, and adipose tissue. Median age at baseline was 59 years (range, 18-97 years), and 28 660 (62.8%) were male. In continuous (per 1-SD increase) multivariable-adjusted analyses, the ?-3 biomarkers ALA, DPA, and DHA were associated with a lower risk of fatal CHD, with relative risks (RRs) of 0.91 (95% CI, 0.84-0.98) for ALA, 0.90 (95% CI, 0.85-0.96) for DPA, and 0.90 (95% CI, 0.84-0.96) for DHA. Although DPA was associated with a lower risk of total CHD (RR, 0.94; 95% CI, 0.90-0.99), ALA (RR, 1.00; 95% CI, 0.95-1.05), EPA (RR, 0.94; 95% CI, 0.87-1.02), and DHA (RR, 0.95; 95% CI, 0.91-1.00) were not. Significant associations with nonfatal MI were not evident. Associations appeared generally stronger in phospholipids and total plasma. Restricted cubic splines did not identify evidence of nonlinearity in dose responses. CONCLUSIONS AND RELEVANCE:On the basis of available studies of free-living populations globally, biomarker concentrations of seafood and plant-derived ?-3 fatty acids are associated with a modestly lower incidence of fatal CHD.

Project description:BackgroundSmoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD.Methods/designAll smokers with PTSD, regardless of their desire to quit, were invited to participate. Enrollment occurred between November 2009 and April 2013. Target enrollment was 120 participants. Enrolled participants were randomized to either the control group, receiving usual care including a telehealth PTSD program, with a device that delivered PTSD information and in-home care management, or the intervention group, which included (1) a telehealth PTSD program, (2) motivational interviewing-based smoking cessation curricula via the telehealth device, and (3) weekly motivational interviewing counseling phone calls. Outcomes are self-reported 24-hour quit attempts, progression along the stages of change and 7-day point prevalence quit smoking rates for the intervention group compared to usual care alone. Secondary outcomes include participants' perception of care coordination, patient satisfaction with motivational interviewing, PTSD symptoms, pain, depression and quality of life.DiscussionMotivational interviewing has been shown to increase readiness for change and smoking cessation care has been shown to be more successful when incorporated into in-person mental health care. Our study builds on previous studies. It integrates a written smoking cessation curriculum and phone-based motivational interviewing counseling into an established PTSD home telehealth care coordination program. This paper describes the design and methods of our randomized control trial.Trial registrationClinicalTrials.gov, NCT00908882, May 22, 2009.

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Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

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Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

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