Digital Data in Mental Health Therapy

Depressive Symptoms Clinical Trial

Official title:

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011540
• Other study ID #: 831246
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Generalized
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Digital data
Receiving digital data prior to a scheduled mental health session

Locations

Country	Name	City	State
United States	Penn Medicine behavioral and mental health clinics	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey	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. A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.	3 months
Secondary	Depressive symptoms, Patient Health Questionnaire-8 (PHQ-8)	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 with other leading major depressive symptoms into a brief self-report tool. PHQ-8 is brief and useful in clinical practice. The PHQ-8 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-8 is a freely available mood-rating questionnaire consisting of nine questions mirroring DSM-IV depression diagnostic criteria. The PHQ-8 has shown diagnostic validity in a study of 3,000 adult patients. Each item is rated on a scale of 0 to 3, giving a maximum score of 24. Cut-off scores are used to label depression severity as: 0 to 4, minimal depression; 5 to 9, mild depression; 10 to 14, moderate depression; 15 to 19, moderately severe depression; 20 to 24, severe depression.	3 months
Secondary	Anxiety symptoms, Generalized Anxiety Disorder-7 (GAD-7)	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. The GAD-7 showed good reliability and criterion, construct, factorial, and procedural validity in a study carried out in 15 primary care clinics. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.	3 months
Secondary	Therapeutic Relationship, Working Alliance Inventory (WAI)	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. Coefficient alphas for the WAI-S three subscales have ranged from 0.85 to 0.92. Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The Goal, Task and Bond domains each have scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance. The WAI-S was highly correlated to the California Psychotherapy Alliance Scale and the Penn Helping Alliance Interview Schedule.	3 months