An interventional study of IntelliCare + Phone Coaching in Mental Health Wellness 1, Depression and Anxiety, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by University of Virginia · Not applicable, Interventional, and Supportive care
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Among 3,709 studies in Depression with a site in United States — 578 open to participants now, 717 under way, 30 of them phase 3. Depression · United States.
Among the 3,709 studies in Depression with a site in United States, this one is the 1,975th largest by planned enrollment of the 3,316 interventional ones that give a count, is one of 164 that started in 2018, is one of 2,215 with no phase, and was the 1,974th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →578 of the 3,709 studies in Depression with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
NeuroRx, Inc. · Sites in United States
Ages 18–80
Ohio State University · Sites in United States
Ages 21–65
Florida State University · Sites in United States
Ages 18–55 · Healthy volunteers
University of Texas Southwestern Medical Center · Sites in United States
Ages 12–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,709 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 235 · Phase 2 441 · Phase 3 285 · Phase 4 265
First in 1977; this study’s year is marked. 164 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 72 across the 3,316 interventional studies, 138 across the 371 observational. Of the 2,761 that completed or were terminated, 1,045 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
392 of 3,709 have an industry lead sponsor. The 10 most frequent:
University of Virginia is the lead sponsor of 676 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
University of Virginia has 9 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Add all 299 to your calendar (.ics) → With an account.
Among the 3,709 studies in Depression with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A cancer diagnosis affects not only patients but also their caregivers. The purpose of this study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the mental health of cancer patients and caregivers.
Cancer patients and/or their caregivers will receive access to the mobile app suite, IntelliCare, as well as phone coaching that will focus on how to use the apps. IntlliCare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). The apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). IntelliCare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive IntelliCare apps with phone coaching for 7 weeks. In this arm, participants will pick two IntelliCare apps to use every week. Participants will receive a phone coaching call before they use the apps, for approximately 30 minutes, as well as 3 weeks after initiating app use (10 minute call).
Behavioral: IntelliCare + Phone Coaching
IntelliCare is composed of 13 separate, native apps. Each app targets a specific aspect of mental health (e.g., reducing worry, increasing social support, tracking negative thoughts). The apps are available to the public in both Android and iPhone stores. Participants will be asked to try two new IntelliCare apps every week, for 7 weeks. Phone coaching will occur at Day 0, before using any of the apps, and the third week of app usage.
Depression Symptoms
Patient-Reported Outcomes Measurement Information System 4-Item Depression Scale (from 29-item Profile), measures depression on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of depression.
Time frame: Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)
Anxiety Symptoms
Patient-Reported Outcomes Measurement Information System 4-Item Anxiety Scale (from 29-item Profile), measures anxiety on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of anxiety.
Time frame: Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline)
Clinical Mood Symptoms
Patient Health Questionnaire-4 contains measures clinical symptoms of mood and anxiety disorders. Scores on this scale range from 0-12, with a higher score indicating greater severity of mood symptoms. Unlike the Patient-Reported Outcomes Measurement Information System scales, this scale has pre-determined clinical cutoffs for mild, moderate, and severe symptoms, which will be used to classify severity of mood symptoms.
Time frame: Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)
Physical Function
Patient-Reported Outcomes Measurement Information System 4-Item Physical Function Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating less impairment of physical function.
Time frame: Change in physical function from baseline to post-intervention (7 weeks after baseline)
Life Meaning/purpose
Patient-Reported Outcomes Measurement Information System 4-Item Life Meaning and Purpose Scale. Scores on this scale range from 4-20, with a higher score indicating more life meaning and purpose.
Time frame: Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
Sleep Quality
Patient-Reported Outcomes Measurement Information System 4-Item Sleep Disturbance Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more sleep disturbance.
Time frame: Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
Fatigue
Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more fatigue.
Time frame: Change in fatigue from baseline to post-intervention (7 weeks after baseline)
Pain Interference
Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more pain interference in daily life.
Time frame: Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
Patient Health Care Utilization
Created a scale since none currently exist. Items (in order) are the following: 1. Over the past two months, how many times did you go to the emergency department? 2. Were any of these visits related to your side effects from cancer treatment? (Yes/No/I Don't Know) 3. How many visits were related to side effects from cancer treatment? 4. Over the past two months, did you ever miss a scheduled appointment for cancer treatment? (Yes/No/I Don't Know) 5. How many appointments did you miss? 6. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to cancer treatment. (Yes/No/I Don't Know) 7. What types of services have you used?
Time frame: Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Caregiver Health Care Utilization
Created a scale since none currently exist. Items (in order) are the following: 1. Over the past two months, how many times did you go to the emergency department? 2. Over the past two months, how many times did you visit your primary care doctor for anything OTHER THAN routine care? 3. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to caregiving for your loved one with cancer. (Yes/No/I Don't Know) 4. What types of services have you used?
Time frame: Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Ability to Participate in Social Roles and Activities
Patient-Reported Outcomes Measurement Information System 4-Item Ability to Participate in Social Roles and Activities Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more ability to participate in social roles and activities in daily life.
Time frame: Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
Caregiver Self-Efficacy
Caregiver Self-Efficacy Scale (CaSES; Ugalde, Krishnasamy, \& Schofield, 2013). A 21-item scale developed to measure self-efficacy in informal cancer caregivers. Scores range from 0-84, with a higher score indicating more self-efficacy.
Time frame: Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)
Positive and Negative Mood
Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Drug Use
How much have you used alcohol or tobacco to cope with negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Pain
How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Social Connectedness
1. How connected did you feel to family and friends? (Scale from 1=Not at all to 5=A lot or extremely) 2. How much support did you receive from loved ones? (Scale from 1=Not at all to 5=A lot or extremely) 3. How much were you able to support loved ones? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Anhedonia
How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Anxiety
How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Physical Activity
How active were you? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Emotion Regulation
How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Future Positive and Negative Mood
Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive)
Time frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Plan to share: No
Started Mar 2018 (actual). Primary completion is estimated for Oct 2018, 7 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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