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Digital Data in Mental Health Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04011540
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Generalized Behavioral: Digital data Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Behavioral: Digital data

No Intervention: Usual Care
Usual care

Primary Outcome Measures :
  1. Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey [ Time Frame: 3 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. 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.

Secondary Outcome Measures :
  1. Depressive symptoms, Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: 3 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 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.

  2. Anxiety symptoms, Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 3 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. 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. Therapeutic Relationship, Working Alliance Inventory (WAI) [ Time Frame: 3 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. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Between 18-65 years of age
  2. Primarily English speaking (for language analysis)
  3. Uses Facebook and/or Instagram and willing to share
  4. Has a gmail account and willing to download and share Google takeout
  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 twice a month and expected 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. Regular activity viewing and posting on social media sites, defined as once a month posting
  10. Owns an iPhone
  11. 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 therapy at Penn and/or has a provider from the Philadelphia Society of Clinical Psychologists
  6. Not expected to remain in 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 an iPhone.
  11. Unwilling to download and keep an app on their phone for 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04011540

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Contact: Lauren E Southwick, MPH (267) 428-0125

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United States, Pennsylvania
Penn Medicine behavioral and mental health clinics Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania Identifier: NCT04011540    
Other Study ID Numbers: 831246
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms