Electronic Communication Augmented Mental Health Care

NCT03925038 | Completed

• 1 other identifier: IRB00184638
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorders; Bipolar Affective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Session Experience Scale

  First visit, then every visit for up to 2 years

• Change in measurement based outcomes as measured by the McLean Treatment Tracking Survey

  First visit, then every visit for up to 2 years

Other Outcomes (6)

• Change in therapist-patient therapeutic relationship as assessed by the Working Alliance Inventory

  Baseline, then every 3 months for up to 2 years

• Change in Anxiety symptoms as assessed by the General Anxiety Disorder 7

  Baseline, then weekly for up to 2 years

• Change in Suicide symptoms as assessed by the Columbia-Suicide Severity Rating Scale

  Baseline, then weekly for up to 2 years

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Participants will receive psychotherapy (treatment as usual).

Behavioral: Treatment as Usual

Augmented Care

EXPERIMENTAL

Participants will receive augmented psychotherapy which includes use of an electronic media dashboard as part of treatment.

Behavioral: Augmented Care: Electronic Media Dashboard; Behavioral: Treatment as Usual

Interventions

Augmented Care: Electronic Media Dashboard BEHAVIORAL

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.

Augmented Care

Treatment as Usual BEHAVIORAL

Participants will receive psychotherapy as treatment as usual.

Augmented Care; Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• Johns Hopkins University: lead
• Once Upon a Time Foundation: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• 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.

  PMID: 25524788 BACKGROUND

• 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.

  PMID: 18314433 BACKGROUND

• 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.

  PMID: 12860775 BACKGROUND

• 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.

  PMID: 21732121 BACKGROUND

• Nesbitt B, Virgadamo D, Aguirre C, DeCamp M, Dredze M, Harrigian K, Lhaksampa T, Meuchel JM, Meyer AM, Walker A, Zirikly A, Chisolm MS, Zandi PP, Miller L. Testing a Dashboard Intervention for Tracking Digital Social Media Activity in Clinical Care of Individuals With Mood and Anxiety Disorders: Protocol and Design Considerations for a Pragmatic Randomized Trial. JMIR Res Protoc. 2025 Mar 5;14:e63279. doi: 10.2196/63279.

  PMID: 40053788 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Margaret Chisolm

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: April 1, 2019
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)