Clinical trial NCT03925038: Electronic Communication Augmented Mental Health Care
Official title: The Use of Electronic Communications-based Automated Technologies to Augment Traditional Mental Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Bipolar Affective Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Once Upon a Time Foundation
First posted: 2019-04-23
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mood and anxiety disorders are the most common mental health conditions in the United States, and are associated with significant morbidity, mortality and overall impairment in functioning. These conditions often have an onset in adolescence and can be especially problematic during this time-period because it can impede normal development and attainment of important milestones. While there are evidence-based treatments for these disorders, these disorders often go untreated or under-treated with negative outcomes, particularly suicide in the case of mood disorders. Electronic communication via text messages and social media are ubiquitous and are often the predominant form of communication in adolescents and young adults. A growing body of research suggests that - at the individual level - electronic communication, including social media, activity can reflect the underlying course of mood and anxiety disorders and reveal associated risks for worsening course and negative outcomes such as suicide.

In this pilot study, the investigators propose to develop and evaluate a dashboard for mental health therapists to augment the care of patients with mood/anxiety disorders.

Detailed description: Mood and anxiety disorders are among the most common mental health disorder in the United States, and these disorders are associated with significant morbidity, mortality and overall impairment in functioning. These disorders often have an onset in adolescence, and suicide is now the second leading cause of death among 15-29 year-olds. Furthermore, adolescent mood and anxiety disorders are increasing, with lifetime prevalence of major depressive disorder for adolescents now estimated at 11%. For adolescents and young adults, untreated mood and anxiety disorders can impede normal development and attainment of important milestones (i.e., high school or college graduation, transition to employment), in addition to greatly increasing the risk of suicide. While there are evidence-based treatments for these disorders, 40% of depressed adolescent patients, for example, do not have a substantial response to initial treatment and only a third experience remission of symptoms. Consequently, there is an urgent need to improve upon current treatments and develop novel approaches to care of depression, as well as other mood and anxiety disorders, in adolescents, young adults, and adults in general.

Electronic communication is ubiquitous. Given this, it has been hypothesized that monitoring electronic communication, including social media, activity in partnership with patients as part of routine clinical care has the potential to prevent negative outcomes of mood and anxiety disorders and greatly improve care of these conditions. At the individual level, electronic communication activity can reflect the underlying course of these disorders and reveal associated risks for worsening course and negative outcomes such as suicide. Automated technologies (e.g., natural language processing systems) may assist therapists in assessing these conditions and risks, by identifying aspects of language use or other key behavior patterns, such as number of friends or time of electronic communication activity, that correlate with an individual's mental health status. At the population level, analysis of aggregated electronic communications data can illuminate important mental health trends across a range of disorders (e.g., depression, bipolar disorder, anxiety, eating disorders). In this pilot study, the investigators propose to develop and evaluate a dashboard for mental health therapists in alliance with patients to augment the care of patients with mood/anxiety disorders and to improve clinical outcomes.

Of note, changes to primary, secondary, and other pre-specified outcomes were made prior to intervention implementation.

Eligibility criteria: Inclusion Criteria:

* Patients ages 12-100 years
* With any diagnosis of a mood or anxiety disorder
* Already established and receiving care in community psychiatry at the Johns Hopkins Bayview Medical Center or at Johns Hopkins Hospital or Kennedy Krieger Institute.

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Change in Depressive symptoms as assessed by the Patient Health Questionnaire 9
timeFrame: Baseline, then weekly for up to 2 years
Secondary outcomes:
measure: Change in Session Experience Scale
timeFrame: First visit, then every visit for up to 2 years
measure: Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey
timeFrame: First visit, then every visit for up to 2 years
Other outcomes:
measure: Change in therapist-patient therapeutic relationship as assessed by the Working Alliance Inventory
timeFrame: Baseline, then every 3 months for up to 2 years
measure: Change in Anxiety symptoms as assessed by the General Anxiety Disorder 7
timeFrame: Baseline, then weekly for up to 2 years
measure: Change in Suicide symptoms as assessed by the Columbia-Suicide Severity Rating Scale
timeFrame: Baseline, then weekly for up to 2 years
measure: Change in self-reported quality of life as assessed by Short Form 36 Mental Health Component (SF-36 MHC)
timeFrame: Baseline, then every 3 months for up to 2 years
measure: Change in satisfaction with services as assessed by Client Satisfaction Questionnaire
timeFrame: Baseline, then every 3 months for up to 2 years
measure: Change in therapist satisfaction with electronic communication data discussion as assessed by Electronic Data and Mental Health Satisfaction Questionnaire
timeFrame: First visit, then every visit for up to 2 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Margaret Chisolm
role: PRINCIPAL_INVESTIGATOR
References:
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