Digital Data in Mental Health Therapy

NCT04011540 | Completed Results

• 1 other identifier: 831246
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment intends to better understand how digital data, social media, and electronic communication can be used in mental health therapy.

Conditions

Depressive Symptoms; Anxiety Generalized

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)

  The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered health-related quality of life (HRQoL) measures. It explores eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state (better outcome).

  2 months

Secondary Outcomes (3)

• Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value

  2 months

• Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value

  2 months

• Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value

  2 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive a personalized digital data dashboards throughout the two-month study period.

Behavioral: Digital data

Usual Care

NO INTERVENTION

Usual care

Interventions

Digital data BEHAVIORAL

Receiving digital data prior to a scheduled mental health session

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-65 years of age
• Primarily English speaking (for language analysis)
• Willing to share at least one digital data source this includes Facebook, Google searches, YouTube searches, or screen time by downloading a free application (app) on their smartphone.
• Regular activity viewing and posting on social media sites, defined as once a month posting
• Has a mental or behavioral health provider and/or has a provider from the Philadelphia Society of Clinical Psychologists and currently enrolled in mental or behavioral therapy
• Attends therapy at least once a month and intends to remain in therapy for the next three months
• Willing to share dashboard with their behavioral health provider
• Able to provide informed consent
• Owns a smartphone
• If the patient downloads an app, they are willing to download and keep an app on their phone for 3 months

You may not qualify if:

• Under 18 years of age
• Non-English speaker
• Patient is in severe distress, e.g. respiratory, physical, or emotional distress
• Patient is intoxicated, unconscious, or unable to appropriately respond to questions
• Not currently enrolled in mental therapy
• Not expected to remain in mental therapy for the next three months
• Not a regular social media poster, or does not use Facebook and/or Instagram and/or not willing to share
• Unwilling to share social media summary dashboard with behavioral health provider
• Patient with diagnosed psychosis
• Does not own a smartphone
• Unwilling to download and keep an app on their phone for 3 months

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine behavioral and mental health clinics

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Lauren Southwick
• Organization: University of Pennsylvania

lauren.southwick@pennmedicine.upenn.edu

267-428-0125

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 2, 2019
• First Posted: July 8, 2019
• Study Start: September 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2023-12

Locations

US (1)