Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will receive a personalized digital data dashboards throughout the two-month study period. |
|
| Usual Care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital data | Behavioral | Receiving digital data prior to a scheduled mental health session |
|
| 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 |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine behavioral and mental health clinics | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants will receive a personalized digital data dashboards throughout the two-month study period. Digital data: Receiving digital data prior to a scheduled mental health session |
| FG001 | Usual Care | Usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants will receive a personalized digital data dashboards throughout the two-month study period. Digital data: Receiving digital data prior to a scheduled mental health session |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
Not monitored/assessed
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants will receive a personalized digital data dashboards throughout the two-month study period. Digital data: Receiving digital data prior to a scheduled mental health session |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Southwick | University of Pennsylvania | 267-428-0125 | lauren.southwick@pennmedicine.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2022 | Feb 9, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Usual care
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Intervention |
Participants will receive a personalized digital data dashboards throughout the two-month study period. Digital data: Receiving digital data prior to a scheduled mental health session |
| OG001 | Usual Care | Usual care |
|
|
| Secondary | 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). | Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| Secondary | 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). | Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| Secondary | 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. | Mean change values from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Usual care | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided