Depressive SymptomsNCT04011540
Digital Data in Mental Health Therapy
A study testing Digital data in people with Depressive Symptoms and Anxiety Generalized, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety Generalized
- What is being tested?
- Digital data
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-65 years of age
- Primarily English speaking (for language analysis)
- 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.
- Regular activity viewing and posting on social media sites, defined as once a month posting
- 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
- Attends therapy at least once a month and intends to remain in therapy for the next three months
Show all 10Show fewer
- Willing to share dashboard with their behavioral health provider
- Able to provide informed consent
- Owns a smartphone
- If the patient downloads an app, they are willing to download and keep an app on their phone for 3 months
Who cannot join
- Under 18 years of age
- Non-English speaker
- Patient is in severe distress, e.g. respiratory, physical, or emotional distress
- Patient is intoxicated, unconscious, or unable to appropriately respond to questions
- Not currently enrolled in mental therapy
- Not expected to remain in mental therapy for the next three months
Show all 11Show fewer
- Not a regular social media poster, or does not use Facebook and/or Instagram and/or not willing to share
- Unwilling to share social media summary dashboard with behavioral health provider
- Patient with diagnosed psychosis
- Does not own a smartphone
- Unwilling to download and keep an app on their phone for 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine behavioral and mental health clinics
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment
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.
- Conditions
- Depressive Symptoms, Anxiety Generalized
- Being tested
- Digital data
- Medical subject headings
- Depression, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital dataBehavioural
Receiving digital data prior to a scheduled mental health session
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive a personalized digital data dashboards throughout the two-month study period. Receives: Behavioral: Digital data |
| Usual Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start21 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011540
- Sponsor's protocol ID
- 831246
- Status last verified
- Dec 2023
- First submitted
- 2 Jul 2019
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Connolly Gibbons MB, Zandi PP, Miller L, Vahia IV, Gallop R, Chiu RY, Kodkany N, Liow Y, Crits-Christoph P. Who benefits from electronic communications data in psychotherapy? Predictors of outcome and alliance in a pooled randomized trial database. Psychother Res. 2026 Sep 17:1-15. doi: 10.1080/10503307.2026.2734089. Online ahead of print.
PubMed 42755118
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment
- ClinicalTrials.gov ID
- NCT04011540
- Acronym / sponsor ID
- 831246
- Conditions
- Depressive Symptoms, Anxiety Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digital dataParticipants will receive a personalized digital data dashboards throughout the two-month study period. |
| Usual Care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between 18-65 years of age
- Primarily English speaking (for language analysis)
- 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.
- Regular activity viewing and posting on social media sites, defined as once a month posting
- 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
Key exclusion criteria (11 listed)
- Under 18 years of age
- Non-English speaker
- Patient is in severe distress, e.g. respiratory, physical, or emotional distress
- Patient is intoxicated, unconscious, or unable to appropriately respond to questions
- Not currently enrolled in mental therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital dataReceiving digital data prior to a scheduled mental health session | Behavioural | Intervention |
Primary outcome
Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)
Time frame: 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).
3 secondary outcomes
Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value
Time frame: 2 months
Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value
Time frame: 2 months
Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42755118Connolly Gibbons MB, Zandi PP, Miller L, Vahia IV, Gallop R, Chiu RY, Kodkany N, Liow Y, Crits-Christoph P. Who benefits from electronic communications data in psychotherapy? Predictors of outcome and alliance in a pooled randomized trial database. Psychother Res. 2026 Sep 17:1-15. doi: 10.1080/10503307.2026.2734089. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital data in people with Depressive Symptoms and Anxiety Generalized, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.