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Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial.

ABSTRACT: Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused counseling in preventing posttraumatic stress after acute MI.The study is a single-center, randomized controlled psychological trial with two active intervention arms. The sample consists of 426 patients aged 18 years or older who are at 'high risk' to develop clinically relevant posttraumatic stress symptoms. 'High risk' patients are identified with three single-item questions with a numeric rating scale (0 to 10) asking about 'pain during MI', 'fear of dying until admission' and/or 'worrying and feeling helpless when being told about having MI'. Exclusion criteria are emergency heart surgery, severe comorbidities, current severe depression, disorientation, cognitive impairment and suicidal ideation. Patients will be randomly allocated to a single 45-minute counseling session targeting either specific MI-triggered traumatic reactions (that is, the verum intervention) or the general role of psychosocial stress in coronary heart disease (that is, the control intervention). The session will take place in the coronary care unit within 48 hours, by the bedside, after patients have reached stable circulatory conditions. Each patient will additionally receive an illustrated information booklet as study material. Sociodemographic factors, psychosocial and medical data, and cardiometabolic risk factors will be assessed during hospitalization. The primary outcome is the interviewer-rated posttraumatic stress level at three-month follow-up, which is hypothesized to be at least 20% lower in the verum group than in the control group using the t-test. Secondary outcomes are posttraumatic stress levels at 12-month follow-up, and psychosocial functioning and cardiometabolic risk factors at both follow-up assessments.If the verum intervention proves to be effective, the study will be the first to show that a brief trauma-focused psychological intervention delivered within a somatic health care setting can reduce the incidence of posttraumatic stress in acute MI patients.ClinicalTrials.gov: NCT01781247.

SUBMITTER: Meister R

PROVIDER: S-EPMC3852224 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial.

Meister Rebecca R Princip Mary M Schmid Jean-Paul JP Schnyder Ulrich U Barth Jürgen J Znoj Hansjörg H Herbert Claudia C von Känel Roland R

Trials 20131011

<h4>Background</h4>Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused c ...[more]

PMID: 24119487

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Project description:ImportancePosttraumatic stress disorder (PTSD) is prevalent among patients who survived an acute coronary syndrome and is associated with adverse outcomes, but the mechanisms underlying these associations are unclear.ObjectiveTo evaluate the association of PTSD with mental stress-induced myocardial ischemia among individuals who survived a myocardial infarction (MI).Design, setting, and participantsThis cross-sectional study included 303 patients aged 18 to 60 years enrolled from a university-affiliated network. Participants had a verified history of MI within 8 months. Data were collected from June 2011 to March 2016, and data analysis was conducted from March to June 2019.ExposuresA clinical diagnosis of PTSD (lifetime and current) was obtained using the Structured Clinical Interview from the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), and PTSD symptom subscales were assessed with the civilian version of the PTSD Symptom Checklist.Main outcomes and measuresPatients received technetium 99m-labeled sestamibi myocardial perfusion imaging at rest, with mental stress (ie, a speech task) and conventional stress (ie, exercise or pharmacologic). A summed difference score (ie, the difference between stress and rest scores) was used to assess ischemia under both stress conditions.ResultsAmong 303 participants (148 [48.8%] women; 198 [65.3%] African American; mean [SD] age, 51 [7] years), the prevalence of PTSD was 14.5% (44 patients). Patients with PTSD had a higher rate of ischemia with mental stress than those without PTSD (12 of 44 [27.3%] vs 38 of 259 [14.7%]; P = .04) and more than twice the mean number of ischemic segments (1.2 [95% CI, 0.5-1.8] vs 0.5 [95% CI, 0.3-0.7]; P < .001), but there was no difference in conventional stress ischemia (10 of 44 [22.7%] vs 60 of 259 [23.2%]; P = .91). Increasing levels of PTSD symptoms were associated with higher odds of ischemia with mental stress (adjusted odds ratio [OR] per 5-point score increase, 1.18; 95% CI 1.04-1.35; P = .01) but not with conventional stress (adjusted OR per 5-point score increase, 1.05; 95% CI, 0.92-1.21; P = .47). Reexperiencing trauma was the symptom cluster most robustly associated with the presence of ischemia with mental stress (adjusted OR per 5-point score increase, 1.87; 95% CI 1.21-2.91; P = .005), followed by avoidance and numbing (adjusted OR per 5-point score increase, 1.51; 95% CI, 1.07-2.14; P = .02).Conclusions and relevanceIn this study of young and middle-aged individuals with MI, with a large representation of women and patients from racial/ethnic minority groups, PTSD was associated with the development of myocardial ischemia with mental stress. A higher ischemic response to mental stress represents a potential pathway associating PTSD with adverse outcomes after MI.

Project description:BackgroundA necessary shift from in-person to remote delivery of psychotherapy (eg, teletherapy, eHealth, videoconferencing) has occurred because of the COVID-19 pandemic. A corollary benefit is a potential fit in terms of the need for equitable and timely access to mental health services in remote and rural locations. Owing to COVID-19, there may be an increase in the demand for timely, virtual delivery of services among trauma-affected populations, including public safety personnel (PSP; eg, paramedics, police, fire, correctional officers), military members, and veterans. There is a lack of evidence on the question of whether digital delivery of trauma-therapies for military members, veterans, and PSP leads to similar outcomes to in-person delivery. Information on barriers and facilitators and recommendations regarding digital-delivery is also scarce.ObjectiveThis study aims to evaluate the scope and quality of peer-reviewed literature on psychotherapeutic digital health interventions delivered remotely to military members, veterans, and PSP and synthesize the knowledge of needs, gaps, barriers to, and facilitators for virtual assessment of and virtual interventions for posttraumatic stress injury.MethodsRelevant studies were identified using MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica dataBASE), APA (American Psychological Association) PsycINFO, CINAHL (Cumulative Index of Nursing and Allied Health Literature) Plus with Full Text, and Military & Government Collection. For collation, analysis, summarizing, and reporting of results, we used the CASP (Critical Skills Appraisal Program) qualitative checklist, PEDro (Physiotherapy Evidence Database) scale, level of evidence hierarchy, PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews), and narrative synthesis.ResultsA total of 38 studies were included in this review. Evidence for the effectiveness of digital delivery of prolonged exposure therapy, cognitive processing therapy, behavioral activation treatment with therapeutic exposure to military members, veterans, and PSP was rated level 1a, whereas evidence for cognitive behavioral therapy was conflicting. The narrative synthesis indicated that virtual delivery of these therapies can be as effective as in-person delivery but may reduce stigma and cost while increasing access to therapy. Issues of risk, safety, potential harm (ie, suicidality, enabling avoidance), privacy, security, and the match among the therapist, modality, and patient warrant further consideration. There is a lack of studies on the influences of gender, racial, and cultural factors that may result in differential outcomes, preferences, and/or needs. An investigation into other therapies that may be suitable for digital delivery is needed.ConclusionsDigital delivery of trauma therapies for military members, veterans, and PSP is a critical area for further research. Although promising evidence exists regarding the effectiveness of digital health within these populations, many questions remain, and a cautious approach to more widespread implementation is warranted.

Project description:BackgroundThe treatment of posttraumatic stress disorder (PTSD) related to a history of sexual and/or physical abuse in childhood is the subject of international debate, with some favouring a phase-based approach as their preferred treatment, while others argue for immediate trauma-focused treatment. A history of (chronic) traumatisation during childhood has been linked to the development of distinct symptoms that are often labelled as symptoms of complex PTSD. Many therapists associate the presence of symptoms of complex PTSD with a less favourable treatment prognosis. The purpose of this study is to determine whether a phase-based approach is more effective than stand-alone trauma-focused therapy in individuals with PTSD and possible symptoms of complex PTSD resulting from a history of repeated sexual and/or physical abuse in childhood. An additional aim is to investigate moderators, predictors of treatment (non) response and drop-out.MethodThe sample consists of patients between 18 and 65 years old with a diagnosis of PTSD who report a history of repeated sexual and/or physical abuse in childhood (N?=?122). Patients will be blindly allocated to either 16 sessions of eye movement desensitization and reprocessing (EMDR) therapy preceded by a stabilization phase (eight sessions of Skills Training in Affect and Interpersonal Regulation (STAIR)) or only 16 sessions of EMDR therapy. Assessments are carried out pre-treatment, after every eighth session, post-treatment, and at 3 and 6 months follow up. The main parameter will be the severity of PTSD symptoms (PTSD Symptoms Scale-Self Report). Secondary outcome variables are the presence of a PTSD diagnosis (Clinician-Administered PTSD Scale for DSM-5), severity of complex PTSD symptoms (Structured Interview for Disorders of Extreme Stress-Revised and symptoms-specific questionnaires), changes in symptoms of general psychopathology (Brief Symptom Inventory), and quality of life (Euroqol-5D). Health care consumption and productivity loss in patients will also be indexed.DiscussionThe study results may help to inform the ongoing debate about whether a phase-based approach has added value over immediate trauma-focused therapy in patients suffering from PTSD due to childhood abuse. Furthermore, the results will contribute to knowledge about the safety, efficacy, and cost-effectiveness of treatments in this target group.Trial registrationNederlands Trialregister, NTR5991 . Registered on 23 august 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5991.

Dataset Information

Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial.

Publications

Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial.

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