Electronic Communication Augmented Mental Health Care
Primary Purpose
Depressive Disorder, Anxiety Disorders, Bipolar Affective Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Care: Electronic Media Dashboard
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
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
Sites / Locations
- Johns Hopkins Bayview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as Usual
Augmented Care
Arm Description
Participants will receive psychotherapy (treatment as usual).
Participants will receive augmented psychotherapy which includes use of an electronic media dashboard as part of treatment.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Session Experience Scale
Items are rated on a 10-point scale (0=Worst; 10=Best).
Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey
Items collect collateral information obtained and treatment decisions.
Full Information
NCT ID
NCT03925038
First Posted
April 19, 2019
Last Updated
September 7, 2023
Sponsor
Johns Hopkins University
Collaborators
Once Upon a Time Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03925038
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Once Upon a Time Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Anxiety Disorders, Bipolar Affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Participants will receive psychotherapy (treatment as usual).
Arm Title
Augmented Care
Arm Type
Experimental
Arm Description
Participants will receive augmented psychotherapy which includes use of an electronic media dashboard as part of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Care: Electronic Media Dashboard
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants will receive psychotherapy as treatment as usual.
Primary Outcome Measure Information:
Title
Change in Depressive symptoms as assessed by the Patient Health Questionnaire 9
Description
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).
Time Frame
Baseline, then weekly for up to 2 years
Secondary Outcome Measure Information:
Title
Change in Session Experience Scale
Description
Items are rated on a 10-point scale (0=Worst; 10=Best).
Time Frame
First visit, then every visit for up to 2 years
Title
Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey
Description
Items collect collateral information obtained and treatment decisions.
Time Frame
First visit, then every visit for up to 2 years
Other Pre-specified Outcome Measures:
Title
Change in therapist-patient therapeutic relationship as assessed by the Working Alliance Inventory
Description
Items are rated on a 5-point scale (1=Seldom; 5=Always).
Time Frame
Baseline, then every 3 months for up to 2 years
Title
Change in Anxiety symptoms as assessed by the General Anxiety Disorder 7
Description
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).
Time Frame
Baseline, then weekly for up to 2 years
Title
Change in Suicide symptoms as assessed by the Columbia-Suicide Severity Rating Scale
Description
Items are dichotomous (yes or no)
Time Frame
Baseline, then weekly for up to 2 years
Title
Change in self-reported quality of life as assessed by Short Form 36 Mental Health Component (SF-36 MHC)
Description
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
Time Frame
Baseline, then every 3 months for up to 2 years
Title
Change in satisfaction with services as assessed by Client Satisfaction Questionnaire
Description
Items are rated on 4-point scale (e.g., 1= Poor; 4= Excellent)
Time Frame
Baseline, then every 3 months for up to 2 years
Title
Change in therapist satisfaction with electronic communication data discussion as assessed by Electronic Data and Mental Health Satisfaction Questionnaire
Description
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
Time Frame
First visit, then every visit for up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Miller, MD
Phone
410 550 9014
Email
lmille84@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Chisolm
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Chisolm, M.D.
First Name & Middle Initial & Last Name & Degree
Peter Zandi, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25524788
Citation
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.
Results Reference
background
PubMed Identifier
18314433
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.
Results Reference
background
PubMed Identifier
12860775
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.
Results Reference
background
PubMed Identifier
21732121
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.
Results Reference
background
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Electronic Communication Augmented Mental Health Care
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