Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04410770 |
| Other study ID # |
90DPTB0016 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2019 |
| Est. completion date |
September 29, 2022 |
Study information
| Verified date |
August 2020 |
| Source |
Memorial Hermann Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Traumatic brain injury (TBI) is a common type of injury that affects thousands of people a
year. TBI can cause a number of disabilities such as impaired cognition, decreased strength,
decreased balance, problems controlling feelings, and difficulty communicating with others.
Other problems that persons with TBI can have in the period after hospital discharge are
anxiety and depress. These problems are common. At about one year after being injured, 44% of
people have anxiety and 40% have depression. By five years after injury, 28% have depression
and 17% have anxiety. If we think of emotional distress as having depression, anxiety, or
both, at one year, 53% of people with TBI have emotional distress and, at five years, 38%
have emotional distress. Many people with TBI are reluctant to seek help for emotional
problems and when they do want help, it is hard to find. Many states have a shortage of
mental health providers, many injured persons lack insurance that would pay for mental health
treatment, and treatment may only be available a long distance from where people live.
In an attempt to address this problem, we are conducting a study designed to determine
whether a self-management strategy can improve emotional distress or make emotional distress
less like to develop. Previous studies have shown that simply keeping track of a problem may
improve it. For example, tracking how often one has headaches can result in fewer headaches.
Keeping track of one's blood pressure can lead to lower blood pressure. We are conducting
this study to see if tracking one's level of emotional distress will result in lower levels
of emotional distress. We are asking people with TBI to rate their levels of emotional
distress several times a week using a special smart phone app. We will then conduct
statistical tests to see if completing these ratings can cause people to have less emotional
distress or prevent emotional distress from developing.
Description:
Self-management Challenges for Persons with TBI:
A coordinated approach to chronic health management has been shown to be effective for a
number of conditions such as asthma, (Wolf, et al., 2002) diabetes, (Glasgow, Funnell, et
al., 2002) heart failure, (Glasgow, et al., 2002) and excess alcohol use (Hospital MM,
Wagner, et al., 2016) among many others. Favorable results have been obtained across a wide
range of clinical populations including adults (Glasgow et al., 2002) and children. (Hospital
et al., 2016) The self-management aspect of chronic health management is often referred to as
enablement. The patient is empowered to take action to improve his/her own health status.
(Battersby, Von Korff, et al., 2010) Steps taken to facilitate this process are called
self-management support. A wide range of self-management strategies have been used to improve
health outcomes. These include skill-based training, goal setting, involvement with community
based programs that provide education and support, self-monitoring, and use of technologies
such as web-based content, text messages, graphic computer based feedback as opposed to
verbal feedback, and others. (Battersby, Von Korff, et al., 2010) As reviewed in the
Importance of the Problem section, persons with TBI have increased risk for a number of
physical, cognitive, behavioral, and emotional co-morbidities that can decrease health and
function, community living, and participation outcomes including employment. Given the
limited availability and poor accessibility of psychiatric, psychological, counseling, and
other mental health services, emotional distress is a particular concern for persons with TBI
and their families. A number of studies have found that clinically significant emotional
distress (defined here as depression, anxiety, or co-morbid depression and anxiety) is common
after TBI. Depression and anxiety are more common in persons with TBI than in persons without
TBI across all age ranges and all injury severities. (Osborn, Mathias, et al., 2016; Dikmen,
Bombardier, et al., 2004) While anxiety may be more common early post-injury, depression is
more problematic in the later years post-injury. (Always, Gould, et al., 2016) In this study,
40.1% of persons with TBI met diagnostic criteria for a depressive disorder at one year
post-injury, while 44.1% had an anxiety disorder. By 5 years post-injury, 27.7% had
depression and 16.8% had anxiety. If psychological distress is operationalized as anxiety,
depression, or both, at year 1, 53.3% had psychological distress and at year 5, 33.7% had
psychological distress. Anxiety and depression after TBI are associated with decreased social
participation, limited independence in community living, decreased participation including
employment, and low life satisfaction.
The frequent occurrence and negative impact of emotional distress after TBI is compounded by
limited availability of mental health care providers and limited ability to access mental
health services due to inability to pay and attitudinal barriers. Persons without TBI face
challenges in obtaining mental health care. Findings from the National Comorbidity Survey
Replication of 9,282 persons selected to represent the general population of the U.S.
indicated that 1,350 (14.5%) met diagnostic criteria for a psychiatric disorder. Of these,
783 did not seek care for their psychiatric symptoms. (Mojtabi, Olfson, et al., 2011) Of
those not seeking care, 44.8% did not perceive that they needed mental health services even
though they met diagnostic criteria. The remaining 55.2% perceived that they needed care, but
did not seek care due to various barriers. Structural barriers included inadequate financial
resources, limited availability of providers, lack of transportation, and perceived
inconvenience. Attitudinal barriers were experienced by about 4 times as many persons as
structural barriers. Attitudinal barriers included perceived ineffectiveness of mental health
services, stigma, and others. (Mojtabi, et al., 2011) These findings are of particular
concern for our Center that serves the greater Houston metropolitan area, outlying areas in
Texas, and various out of state and international constituencies. As reviewed in Section A -
Importance of the Problem, Texas ranks in the lower 10% of all states in access to mental
health care, persons needing mental health services who have insurance, and availability of
mental health providers. (Mental Health in America, 2017) Poor accessibility of mental health
services due to poor availability, cost of care, and various attitudinal barriers indicates
the need for alternative service delivery models. Some encouragement is provided by a recent
study (Bernecker, Banschback, et al., 2017) that found that of persons who needed mental
health interventions but indicated that they would not use traditional psychotherapy even if
they had an available provider and ability to pay, 51% indicated that they would be open to
trying a web-based utility that would provide self-help and peer-support. Persons with TBI
are even more challenged in accessing mental health services than the general population due
to having more limited transportation options, being less likely to have healthcare coverage,
and an even greater shortage of specialized providers.
Use of Technologic Solutions to Provide Mental Health Services in the Context of Health
Management and Treatment of Emotional Distress in Persons with TBI:
The chronic health management literature provides a number of examples of electronic
technologies used to support patient use of self-management strategies. In an intervention to
decrease underage drinking, teens received text messages providing information about negative
consequences of alcohol use, prompts to enhance self-efficacy, and social support. (Hospital
et al., 2016) Teens receiving these messages showed greater interest in decreasing alcohol
use than those who received control messages. A web based program was used to increase
patient behavioral activation in an effort to increase self-management behaviors in a cohort
including persons with asthma, hypertension, or diabetes. (Solomon, Wagner, Goes, 2012)
Patients receiving this intervention showed greater increases in behavioral activation as
indicated by higher self-efficacy and more regular tracking of health indicators such as
medication compliance, glucose levels, and blood pressure than those not receiving the
intervention.
In the psychotherapy literature, behavioral activation is often used as an intervention to
decrease emotional distress. (Kanter, Manos, Bowe, et al., 2010) Key elements of behavioral
activation include activity monitoring, assessment of life goals and values, activity
scheduling, skills training, relaxation training, contingency management, procedures
targeting verbal behavior, and procedures targeting avoidance. While these interventions are
normally provided as a coordinated, comprehensive treatment, investigations have shown that
self-monitoring of level of emotional distress is effective in improving mood. (Harmon,
Nelson, Hayes, 1980; Manos, Kanter, Luo, 2011) In a different context, self-monitoring of
risky behaviors in persons living with HIV has been shown to be an effective intervention to
reduce these behaviors. (Lightfoot, Rotheram-Borus, et al., 2007) Given the high level of
availability of smart phone technology throughout American society and the extensive
familiarity with use of this technology possessed by most persons, smart phone based apps
offer an attractive platform for providing low cost, easily assessed interventions for
emotional distress in persons with TBI. Interventions provided through this medium are not be
limited by barriers such as limited availability of providers, inability to afford care,
perceived stigma of accessing care in office settings, and perceived inconvenience and
ineffectiveness of standard office/clinic based mental services.
In a recent systematic review of smartphone apps used to address mental health issues, Donker
and colleages (2013) determined that there are over 3,000 mental health related apps
available for download. In aggregate, these apps have been downloaded hundreds of thousands
of times. However, the systematic review revealed only 8 investigations of the effectiveness
of these interventions. While findings were mixed, there was preliminary evidence that
interventions delivered using this technology can cause clinically meaningful reductions in
anxiety and depression. (Donker et al.,2013) Investigations of the use of these technologies
to address emotional distress in persons with TBI are even more rare. Suffoletto and
colleagues (2013) used educational text messages and symptom monitoring to reduce
post-concussive symptoms in persons with mild TBI. Analyses revealed trends for reduction of
severity for all symptoms over time but none of the effects was significant perhaps due to
inadequate power. All participants believed the text messages were at least somewhat helpful.
In another investigation, a smartphone app was used to monitor levels of depression and
anxiety in 17 persons with TBI. (Juengst, Graham, et al., 2015) Self-ratings on the app were
compared to results from assessments conducted by telephone. Among all 17 participants, 73.4%
of scheduled app based assessments were completed indicating good compliance. Participants
were generally satisfied with the experience of using the app. Self-ratings on the app were
strongly correlated (0.81 to 0.91) with results of assessments conducted by phone. These
findings indicate that this app has potential for use in ongoing monitoring, but the possible
of effect of self-monitoring on severity of symptoms was not assessed.
Rationale for Proposed Study:
The current view of TBI as a chronic health condition indicates the need for long-term
coordinated follow-up using principles of Chronic Care Management to identify late
complications when they occur and provide appropriate interventions including self-management
strategies. Emotional distress is a very common late complication that occurs with greater
frequency for persons with TBI than for persons from the general population. Emotional
distress in persons with TBI is associated with decreased function, limited independence with
community living, decreased participation in community activities including employment, and
deceased life satisfaction. However, treatment of emotional distress is complicated by
reluctance of affected persons to seek care, limited availability of mental health care
providers, inaccessibility of care due to inability to pay, perceived stigma of receiving
mental health services, and perceived ineffectiveness and inconvenience of mental health
care. Smartphone based apps offer an attractive option for addressing these issues. Apps are
low cost; most mental health apps are available as free downloads. Their use is not limited
by the inadequate availability of providers. Since the inconvenience of using an app is
limited, the burden for attempting treatment and receiving no benefit is minimized. As a
result, the numbers of persons who decline to access care due to perceived inconvenience and
ineffectiveness may be decreased. The perceived stigma of seeking mental health services may
also be decreased when these services are provided in a minimally intrusive manner by an app.
A recent investigation found that over half of persons who indicated that they would not seek
traditional psychotherapy were willing to use an app to address problem areas. (Bernecker,
Banschback, et al., 2017) Apps have been shown to be an effective technology for tracking
severity of emotional distress and there is evidence that monitoring of emotional distress is
an efficacious treatment for decreasing distress.
Our proposed local research project will contribute to a coherent, sustained effort on
application of chronic health management principles to long-term care for persons with TBI
and add new knowledge to the current state of the art in this area of research. The specific
aims, hypotheses, planned intervention, target population, and methodology for our proposed
project were informed by our state of the art review of the relevant scientific literature on
self-management strategies as applied to persons with TBI. The plan for statistical analysis
and sample size calculations were developed by our team biostatistician. As we describe
below, we have access to a much larger potential pool of participants than we will need to
screen in order reach our sample size target. The research design was informed by our
previous clinical trials including a telemedicine trial using counseling provided by phone
calls. The target of this trial was informed by numerous focus groups with persons with TBI
and families who have identified emotional distress as a key concern in the post-acute period
after injury. We also obtained feedback from persons with injury regarding ease of use of the
mood tracker app. Data collection procedures and selection of measures were informed by the
scientific literature and our prior experience with these procedures and measures. This
investigation is at the Intervention Efficacy Stage of Research. This will be an initial
investigation of a smartphone based technology to reduce emotional distress in persons with
TBI. The investigation will test the feasibility and practicality of this type of
intervention in this population. Findings will have implications for how this type of
intervention can be modified to be provided in the most effective manner.
Based on this review, we propose to conduct a randomized controlled trial of a smartphone app
based self-monitoring intervention augmented by brief supportive telephone calls to decrease
emotional distress in persons with TBI. This trial will be registered with
ClinicalTrials.gov.
Specific Aims and Hypotheses:
Specific Aim 1: Determine the efficacy of self-monitoring of emotional distress using a
smartphone app with accompanying by supportive telephone calls to decrease emotional distress
in persons with TBI.
Hypothesis 1: Persons receiving the intervention will show a greater decrease in emotional
distress at the post-treatment assessment (time 1) for the intervention group and the 2nd
baseline assessment for the waitlist control group (time 1) as compared to the 1st baseline
assessment (time 0).
Hypothesis 2: Both groups will show a reduction in emotional distress compared to their
baseline levels of distress assessed prior to the intervention. For the intervention group,
time 1 will be compared to time 0 and for the waitlist control group, time 2 will be compared
to time 1.
Specific Aim 2: Determine factors that determine the magnitude of treatment effect.
Hypothesis 1: Greater engagement with the smartphone app as indicated by higher numbers of
times the app was used to rate the degree of emotional distress and more days that ratings
were completed during the intervention phase of the trial will be associated with greater
decrease in emotional distress.
Specific Aim 3: Determine the persistence of the reduction of emotional distress once
telephone counseling calls are discontinued.
Hypothesis 1: The initial reduction in emotional distress will diminish over time with a
tendency for level of emotional distress to return to baseline.
Hypothesis 2: Maintenance of the initial reduction in the degree of emotional distress will
be greater for participants who continue to use the smartphone app regularly.
