Digital Data in Mental Health Therapy

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Anxiety Generalized
• Intervention / Treatment: Behavioral: Digital data

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine behavioral and mental health clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Between 18-65 years of age
2. Primarily English speaking (for language analysis)
3. 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.
4. Regular activity viewing and posting on social media sites, defined as once a month posting
5. 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
6. Attends therapy at least once a month and intends to remain in therapy for the next three months
7. Willing to share dashboard with their behavioral health provider
8. Able to provide informed consent
9. Owns a smartphone
10. If the patient downloads an app, they are willing to download and keep an app on their phone for 3 months

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care
Experimental: Intervention; Participants will receive a personalized digital data dashboards throughout the two-month study period.	Behavioral: Digital data; Receiving digital data prior to a scheduled mental health session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value	Patient health questionnaire-8 (PHQ-8) (Kroenke, Spitzer, & Williams, 2001) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-8 incorporates DSM-IV depression diagnostic criteria. Each question is rated on a scale of 0 to 3, minimum score is 0 and maximum score is 24. A total of 8 questions are administered. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).	2 months
Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value	GAD-7 is a 7-item anxiety scale. It has good reliability, as well as criterion, construct, factorial, and procedural validity. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day with a maximum score of 21 Scores are interpreted as 5 to 9, mild anxiety; 10 to 14, moderate anxiety; and 15 and above, severe anxiety. Lower scores represent mild anxiety (better outcome) while higher scores represent severe anxiety (worse outcome).	2 months
Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value	Working Alliance Inventory (WAI) (Horvath and Greenberg 1986) is used to measure the service user-psychiatrist relationship from the service user perspective. The Working Alliance Inventory-Short Version (WAI-S) is based upon Bordins three-factor conceptualization of the provider and client relationship: collaboration on tasks, collaboration on goals and the bond between the client and therapist. Participants rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The total score is simply the sum of all the scores with the appropriate negative items reversed prior to summing. The total score ranges from 5 to 20. Higher scores indicate a better therapeutic alliance (better outcome). Higher positive mean change score represents 'worsened' alliance, whereas negative mean change score represents 'improved' alliance.	2 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 831246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No