Electronic Communication Augmented Mental Health Care

February 19, 2024 updated by: Johns Hopkins University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as Usual
Participants will receive psychotherapy (treatment as usual).
Participants will receive psychotherapy as treatment as usual.
Experimental: Augmented Care
Participants will receive augmented psychotherapy which includes use of an electronic media dashboard as part of treatment.
Participants will receive psychotherapy as treatment as usual.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depressive symptoms as assessed by the Patient Health Questionnaire 9
Time Frame: Baseline, then weekly for up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Session Experience Scale
Time Frame: First visit, then every visit for up to 2 years
Items are rated on a 10-point scale (0=Worst; 10=Best).
First visit, then every visit for up to 2 years
Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey
Time Frame: First visit, then every visit for up to 2 years
Items collect collateral information obtained and treatment decisions.
First visit, then every visit for up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in therapist-patient therapeutic relationship as assessed by the Working Alliance Inventory
Time Frame: Baseline, then every 3 months for up to 2 years
Items are rated on a 5-point scale (1=Seldom; 5=Always).
Baseline, then every 3 months for up to 2 years
Change in Anxiety symptoms as assessed by the General Anxiety Disorder 7
Time Frame: Baseline, then weekly for up to 2 years
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
Change in Suicide symptoms as assessed by the Columbia-Suicide Severity Rating Scale
Time Frame: Baseline, then weekly for up to 2 years
Items are dichotomous (yes or no)
Baseline, then weekly for up to 2 years
Change in self-reported quality of life as assessed by Short Form 36 Mental Health Component (SF-36 MHC)
Time Frame: Baseline, then every 3 months for up to 2 years
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
Change in satisfaction with services as assessed by Client Satisfaction Questionnaire
Time Frame: Baseline, then every 3 months for up to 2 years
Items are rated on 4-point scale (e.g., 1= Poor; 4= Excellent)
Baseline, then every 3 months for up to 2 years
Change in therapist satisfaction with electronic communication data discussion as assessed by Electronic Data and Mental Health Satisfaction Questionnaire
Time Frame: First visit, then every visit for up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Margaret Chisolm, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

February 19, 2024

Study Completion (Actual)

February 19, 2024

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on Treatment as Usual

Subscribe