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Digital Data in Mental Health Therapy

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04011540
Enrollment
115
Registered
2019-07-08
Start date
2020-09-21
Completion date
2021-12-31
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Generalized, Depressive Symptoms

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.

Interventions

BEHAVIORALDigital data

Receiving digital data prior to a scheduled mental health session

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)2 monthsThe 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

MeasureTime frameDescription
Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value2 monthsPatient 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 Value2 monthsGAD-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 Value2 monthsWorking 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
57
Usual Care
Usual care
58
Total115

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up96

Baseline characteristics

CharacteristicUsual CareTotalIntervention
Age, Continuous32.2 years
STANDARD_DEVIATION 11.2
31.5 years
STANDARD_DEVIATION 10.5
30.9 years
STANDARD_DEVIATION 9.9
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants12 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
54 Participants103 Participants49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants7 Participants5 Participants
Race (NIH/OMB)
Black or African American
6 Participants7 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
50 Participants98 Participants48 Participants
Sex: Female, Male
Female
46 Participants94 Participants48 Participants
Sex: Female, Male
Male
12 Participants21 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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).

Time frame: 2 months

Population: 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.

ArmMeasureValue (MEAN)
InterventionHealth-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)-0.89 score on a scale
Usual CareHealth-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)-1.85 score on a scale
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).

Time frame: 2 months

Population: 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.

ArmMeasureValue (MEAN)
InterventionAnxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value-0.90 score on a scale
Usual CareAnxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value-1.14 score on a scale
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).

Time frame: 2 months

Population: 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.

ArmMeasureValue (MEAN)
InterventionDepressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value-1.20 score on a scale
Usual CareDepressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value-0.44 score on a scale
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.

Time frame: 2 months

Population: 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.

ArmMeasureValue (MEAN)
InterventionTherapeutic Relationship, Working Alliance Inventory (WAI) Change Value0.36 score on a scale
Usual CareTherapeutic Relationship, Working Alliance Inventory (WAI) Change Value-0.65 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026