Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | August 1, 2018 |
| End Date: | December 2019 |
| Contact: | Alex Sullivan, MPH |
| Email: | as5068@cumc.columbia.edu |
| Phone: | 212-342-1258 |
Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial
The overall purpose of this project is to determine the feasibility of conducting a
randomized clinical trial that compares written exposure therapy with usual care among
patients at risk for cardiovascular event-induced PTSD.
Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and
cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the
trauma of the acute medical event. The goal of this study is to test the feasibility of
conducting a randomized trial involving a psychological intervention to prevent the
development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with
these acute cardiovascular events will first be screened for PTSD risk factors while
in-hospital after the index event. These risk factors will include elevated threat
perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the
cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the
intervention group or usual care. Those assigned to the intervention will participate in 5
sessions of written exposure therapy in which they are asked to write about the experience of
their cardiovascular event with guidance from a trained study clinician. At 1 month after
discharge, all patients will be contacted by phone to complete a questionnaire that assesses
PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to
understand the feasibility of testing the written exposure therapy intervention as part of a
larger, fully powered clinical trial.
randomized clinical trial that compares written exposure therapy with usual care among
patients at risk for cardiovascular event-induced PTSD.
Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and
cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the
trauma of the acute medical event. The goal of this study is to test the feasibility of
conducting a randomized trial involving a psychological intervention to prevent the
development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with
these acute cardiovascular events will first be screened for PTSD risk factors while
in-hospital after the index event. These risk factors will include elevated threat
perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the
cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the
intervention group or usual care. Those assigned to the intervention will participate in 5
sessions of written exposure therapy in which they are asked to write about the experience of
their cardiovascular event with guidance from a trained study clinician. At 1 month after
discharge, all patients will be contacted by phone to complete a questionnaire that assesses
PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to
understand the feasibility of testing the written exposure therapy intervention as part of a
larger, fully powered clinical trial.
Experiencing a life threatening cardiovascular event, such as a stroke, transient ischemic
attack (TIA), acute coronary syndrome (ACS), or cardiac arrest has been found to be
associated with PTSD symptoms in up to 1 in 3 survivors. Patients with elevated PTSD symptoms
are at risk for lower medication adherence, increased readmissions, recurrent cardiovascular
events, and worsened quality of life. Risk for recurrent cardiovascular events is especially
high in the initial weeks after acute cardiovascular events, and existing epidemiological
data suggest that PTSD symptoms increase this risk. Thus, intervening early to prevent PTSD
symptoms prior to waiting the full one or more months to make a PTSD diagnosis may provide
new opportunities for offsetting cardiovascular disease (CVD) risk. Despite these adverse
consequence of cardiovascular event-induced PTSD, these patients are not currently being
systematically screened or treated to prevent PTSD symptoms, in part because there is no
evidence assessing the effect of early interventions in this patient population.
A growing number of studies have been evaluating early interventions after trauma to prevent
PTSD. While there is no gold-standard intervention, psychological interventions grounded in
trauma-focused, cognitive behavioral therapy (CBT) have shown promise in some populations.
For example, compared to a supportive counseling control condition, CBT has been found to
reduce PTSD symptom severity and incidence in individuals with acute stress disorder (ASD),
an early manifestation of posttraumatic stress, detected within the first month of a
traumatic event. Preliminary research suggests that an exposure-based CBT intervention
delivered in the immediate aftermath of trauma for individuals meeting Criterion A of a
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) PTSD diagnosis
may also hold promise for PTSD prevention. Acute cardiovascular events such as stroke and ACS
as the source of trauma are inherently different from other forms of stressors that commonly
lead to PTSD. As opposed to an external and past traumatic threat (e.g., combat,
physical/emotional abuse), these events can represent an ongoing internal somatic threat.
Accordingly, treatments for preventing PTSD such as the trauma-focused CBT interventions
discussed above need to be formally evaluated in this distinct patient population before
generalizing the findings from other patient populations. In particular, the willingness to
engage in therapies to prevent or reduce PTSD symptoms may differ in this patient population.
Few of these patients are actively seeking treatment. Many may not be aware of potential
psychological symptoms that can begin or worsen after these events and may not perceive their
psychological symptoms to be problematic. Hence, the acceptability of psychological
interventions is particularly relevant in this patient population.
Written exposure therapy represents a promising intervention to prevent PTSD after
cardiovascular events. Written exposure therapy is a brief exposure-based therapy, founded on
the principles of Pennebaker and Beale's written disclosure procedure. The treatment protocol
consists of 5 sessions, each comprising 30 minutes of writing. In each session, participants
are instructed to write about their memory of the traumatic event with particular attention
to the felt emotions and the meaning of the event. The initial session also incorporates
psychoeducation and review of the rationale for the intervention by a study clinician.
Sessions end with therapists' discussing how the writing session went. The rationale behind
this exposure therapy is that there is a significant habituation of emotional reactivity to
reminders of the traumatic event over repeated writing sessions. Consistent with this
rationale, research suggests that these exposure writing sessions are associated with greater
initial emotional and physiological reactivity and greater habituation of these responses
over time compared to a control writing condition. A recent study showed that this brief
psychotherapy approach was non-inferior to a more extensive CBT approach (cognitive
processing therapy) for reducing PTSD symptoms in adults with PTSD. Written exposure therapy
has also been shown to be effective at lowering PTSD symptoms in patients with motor vehicle
accident-induced PTSD.
In contrast with more standard CBT interventions, written exposure therapy was designed to
create a more acceptable exposure-based treatment option for PTSD that is easily disseminated
and implemented. Like the promising trauma-focused CBT interventions for PTSD prevention, it
is also exposure-based. In light of these qualities, written exposure therapy thus may be
ideally suited for reducing PTSD symptoms in non-treatment seeking survivors of acute
cardiovascular events. Key differences between written exposure therapy and other CBT
approaches to treating PTSD include a lower frequency of sessions (~5) and no homework
requirement, resulting in higher treatment completion compared to a more rigorous
exposure-based therapy approach. Other advantages of written exposure therapy are that it
requires a lower level of training from clinicians and less clinician time, which could
facilitate dissemination.
attack (TIA), acute coronary syndrome (ACS), or cardiac arrest has been found to be
associated with PTSD symptoms in up to 1 in 3 survivors. Patients with elevated PTSD symptoms
are at risk for lower medication adherence, increased readmissions, recurrent cardiovascular
events, and worsened quality of life. Risk for recurrent cardiovascular events is especially
high in the initial weeks after acute cardiovascular events, and existing epidemiological
data suggest that PTSD symptoms increase this risk. Thus, intervening early to prevent PTSD
symptoms prior to waiting the full one or more months to make a PTSD diagnosis may provide
new opportunities for offsetting cardiovascular disease (CVD) risk. Despite these adverse
consequence of cardiovascular event-induced PTSD, these patients are not currently being
systematically screened or treated to prevent PTSD symptoms, in part because there is no
evidence assessing the effect of early interventions in this patient population.
A growing number of studies have been evaluating early interventions after trauma to prevent
PTSD. While there is no gold-standard intervention, psychological interventions grounded in
trauma-focused, cognitive behavioral therapy (CBT) have shown promise in some populations.
For example, compared to a supportive counseling control condition, CBT has been found to
reduce PTSD symptom severity and incidence in individuals with acute stress disorder (ASD),
an early manifestation of posttraumatic stress, detected within the first month of a
traumatic event. Preliminary research suggests that an exposure-based CBT intervention
delivered in the immediate aftermath of trauma for individuals meeting Criterion A of a
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) PTSD diagnosis
may also hold promise for PTSD prevention. Acute cardiovascular events such as stroke and ACS
as the source of trauma are inherently different from other forms of stressors that commonly
lead to PTSD. As opposed to an external and past traumatic threat (e.g., combat,
physical/emotional abuse), these events can represent an ongoing internal somatic threat.
Accordingly, treatments for preventing PTSD such as the trauma-focused CBT interventions
discussed above need to be formally evaluated in this distinct patient population before
generalizing the findings from other patient populations. In particular, the willingness to
engage in therapies to prevent or reduce PTSD symptoms may differ in this patient population.
Few of these patients are actively seeking treatment. Many may not be aware of potential
psychological symptoms that can begin or worsen after these events and may not perceive their
psychological symptoms to be problematic. Hence, the acceptability of psychological
interventions is particularly relevant in this patient population.
Written exposure therapy represents a promising intervention to prevent PTSD after
cardiovascular events. Written exposure therapy is a brief exposure-based therapy, founded on
the principles of Pennebaker and Beale's written disclosure procedure. The treatment protocol
consists of 5 sessions, each comprising 30 minutes of writing. In each session, participants
are instructed to write about their memory of the traumatic event with particular attention
to the felt emotions and the meaning of the event. The initial session also incorporates
psychoeducation and review of the rationale for the intervention by a study clinician.
Sessions end with therapists' discussing how the writing session went. The rationale behind
this exposure therapy is that there is a significant habituation of emotional reactivity to
reminders of the traumatic event over repeated writing sessions. Consistent with this
rationale, research suggests that these exposure writing sessions are associated with greater
initial emotional and physiological reactivity and greater habituation of these responses
over time compared to a control writing condition. A recent study showed that this brief
psychotherapy approach was non-inferior to a more extensive CBT approach (cognitive
processing therapy) for reducing PTSD symptoms in adults with PTSD. Written exposure therapy
has also been shown to be effective at lowering PTSD symptoms in patients with motor vehicle
accident-induced PTSD.
In contrast with more standard CBT interventions, written exposure therapy was designed to
create a more acceptable exposure-based treatment option for PTSD that is easily disseminated
and implemented. Like the promising trauma-focused CBT interventions for PTSD prevention, it
is also exposure-based. In light of these qualities, written exposure therapy thus may be
ideally suited for reducing PTSD symptoms in non-treatment seeking survivors of acute
cardiovascular events. Key differences between written exposure therapy and other CBT
approaches to treating PTSD include a lower frequency of sessions (~5) and no homework
requirement, resulting in higher treatment completion compared to a more rigorous
exposure-based therapy approach. Other advantages of written exposure therapy are that it
requires a lower level of training from clinicians and less clinician time, which could
facilitate dissemination.
Inclusion Criteria:
- Hospitalized with acute stroke, TIA, ACS, or cardiac arrest
- Enrolled in REACH-stroke, PHS, or REACH-cardiac arrest observational cohort studies
- Elevated ASD symptoms (ASD score >=28) and/or elevated threat perceptions during index
hospitalization (ED threat score >=12)
Exclusion Criteria:
- Unavailable for follow-up for written exposure therapy sessions
- Unable to read and write in English
We found this trial at
1
site
622 West 168th Street
New York, New York 10032
New York, New York 10032
Phone: 212-342-4527
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