Electronic Communication Augmented Mental Health Care

Anxiety Disorders Clinical Trial

Official title:

The Use of Electronic Communications-based Automated Technologies to Augment Traditional Mental Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925038
• Other study ID #: IRB00184638
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: February 19, 2024

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 19, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Affective Disorder
• Bipolar Disorder
• Depressive Disorder
• Mood Disorders

Intervention

Behavioral:
• Augmented Care: Electronic Media Dashboard
A participant-specific dashboard that highlights patterns of patient electronic communication usage relevant to understanding participants' mental health will be developed and used to augment treatment as usual.
• Treatment as Usual
Participants will receive psychotherapy as treatment as usual.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Once Upon a Time Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Avenevoli S, Swendsen J, He JP, Burstein M, Merikangas KR. Major depression in the national comorbidity survey-adolescent supplement: prevalence, correlates, and treatment. J Am Acad Child Adolesc Psychiatry. 2015 Jan;54(1):37-44.e2. doi: 10.1016/j.jaac.2014.10.010. Epub 2014 Oct 29. — View Citation

Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901. Erratum In: JAMA. 2019 Nov 5;322(17):1718. — View Citation

Kim-Cohen J, Caspi A, Moffitt TE, Harrington H, Milne BJ, Poulton R. Prior juvenile diagnoses in adults with mental disorder: developmental follow-back of a prospective-longitudinal cohort. Arch Gen Psychiatry. 2003 Jul;60(7):709-17. doi: 10.1001/archpsyc.60.7.709. — View Citation

McLaughlin KA. The public health impact of major depression: a call for interdisciplinary prevention efforts. Prev Sci. 2011 Dec;12(4):361-71. doi: 10.1007/s11121-011-0231-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in therapist-patient therapeutic relationship as assessed by the Working Alliance Inventory	Items are rated on a 5-point scale (1=Seldom; 5=Always).	Baseline, then every 3 months for up to 2 years
Other	Change in Anxiety symptoms as assessed by the General Anxiety Disorder 7	Items are rated on a 4-point scale (0=not at all; 3=Nearly every day). A total score range (0-21) is computed based on patient self-reports on the seven items. Anxiety severity is interpreted based on the total score (1-5 = Minimal anxiety; 15-21= Severe anxiety).	Baseline, then weekly for up to 2 years
Other	Change in Suicide symptoms as assessed by the Columbia-Suicide Severity Rating Scale	Items are dichotomous (yes or no)	Baseline, then weekly for up to 2 years
Other	Change in self-reported quality of life as assessed by Short Form 36 Mental Health Component (SF-36 MHC)	Items are dichotomous (yes or no), and rated on 5-point (1= Not at all; 5= Extremely) and 6-point (1=All of the time; 6= None of the time)scales	Baseline, then every 3 months for up to 2 years
Other	Change in satisfaction with services as assessed by Client Satisfaction Questionnaire	Items are rated on 4-point scale (e.g., 1= Poor; 4= Excellent)	Baseline, then every 3 months for up to 2 years
Other	Change in therapist satisfaction with electronic communication data discussion as assessed by Electronic Data and Mental Health Satisfaction Questionnaire	Items are rated on a 7-point scale (1= Not at all; 7= A great deal) including additional items that inquire about effects of electronic communication data discussion	First visit, then every visit for up to 2 years
Primary	Change in Depressive symptoms as assessed by the Patient Health Questionnaire 9	Items are rated on a 4-point scale (0=not at all, 3=Nearly every day). A total score range of 0-27 is computed based on patient self-reports on the nine items. Depression severity is interpreted based on the total score (1-4= Minimal depression; 20-27= Severe depression).	Baseline, then weekly for up to 2 years
Secondary	Change in Session Experience Scale	Items are rated on a 10-point scale (0=Worst; 10=Best).	First visit, then every visit for up to 2 years
Secondary	Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey	Items collect collateral information obtained and treatment decisions.	First visit, then every visit for up to 2 years