Digital Data in Mental Health Therapy

Not Applicable

Completed

• Conditions: Depressive Symptoms; Anxiety Generalized
• Interventions: Behavioral: Digital data

• Registration Number: NCT04011540
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2020-09-21
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-05-11
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value	2 months	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).
Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value	2 months	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).
Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value	2 months	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.

Trial Locations

Locations (1)

Penn Medicine behavioral and mental health clinics; 🇺🇸 Philadelphia, Pennsylvania, United States