An interventional study of Pacifica App in Anxiety, Stress and Depression, sponsored by Pacifica Labs Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Pacifica Labs Inc. · Not applicable, Interventional, and Treatment
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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 291st largest by enrollment of the 3,316 interventional ones that give a count, is one of 141 that started in 2017, is one of 2,215 with no phase, and was the 1,923rd 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 · no healthy volunteers.
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. 141 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 500 is above 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.
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392 of 3,709 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Pacifica Labs Inc. as lead sponsor.
Pacifica Labs Inc. has 1 study 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.
The study is designed to examine the efficacy of a mobile application implementation of existing best practices in mental health treatment for managing stress, anxiety, and depression.
Over 61 million adults in the U.S. experience mental illness in a given year, and only 1 in 3 will receive professional care due to difficulties with access to care, stigma, cost, or time involved in seeking treatment. Pacifica Labs, Inc., produces a Mobile Application ("app") which integrates existing best practices in treatment for stress, anxiety, and depression. One major goal of the app is to empower individuals to effectively self-manage their anxiety and depression. Pacifica has been used in a pilot research study, amongst a group of nonclinical college student volunteers. It was found to have a preventative effect on stress levels (as measured by the DASS-21). The current study is designed to consider a broader population of potential users.
Study Product Pacifica is a mobile app designed to teach users strategies to manage their stress, anxiety, and depression. Users can choose which tools they want to use. The strategies are digital implementations of existing practices in psychology such as thought records, mindfulness meditation \& relaxation exercises, and behavioral activation. Pacifica includes optional "guided paths" of daily psychoeducation and and activities, which users can follow if they like. The app also includes features like mood and health tracking to help individuals notice patterns in their moods and make adjustments to their activities to manage their emotions more effectively. Additionally, there is a "hope board" which serves as a place for users to put inspirational quotes, reassuring photos, or save their completed activities to be reminded of their successes in using the app. Finally, the app offers a peer support community, which is a discussion board for users to connect with others going through similar experiences or who share interests.
The interventions based on Cognitive-Behavioral Therapy (CBT) include the "Thoughts" tool, which educates users about the effect of thinking errors or "cognitive distortions" on emotions and then prompts users to complete a text-based thought record, identify any cognitive distortions, and then challenge those thoughts (via positive reframe). The "Goals" tool is also based on CBT and allows users to create a list of goals to face their fears (in the case of anxiety) or re-engage with life (for those struggling with depression). The tool helps users to track their tasks and progress.
The interventions based on Mindfulness include "Meditations" which provides a suite of activities for users to learn mindfulness, practice deep breathing or body scans, guided relaxation activities, or simply listen to soothing sounds.
Pacifica also offers health-behavior tracking which allows users to monitor activities of their choice such as caffeine consumption, exercise, time spent with loved ones, etc. Users can also track their mood state "How are you feeling?" (scale of 1 = awful to 7 = great). Additionally, users can create and track custom health activities and associate words with their mood from pre-set options such as "stressed" or "happy" or can specify their own words using a hashtag such as "#engaged".
Users are able to see a visual display of their within-app self-monitoring data through the "Progress" function of the app.
The commercially available Pacifica app also allows users to connect to their health care providers through the "My Therapist" tab. This feature will be disabled for the present research study.
Participants in the study will be allowed to use whichever tools they want, in the same way that regular app users can. There is no minimum or maximum "dose" specified.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 500 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Pacifica Labs Inc. as lead sponsor.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 be provided will full access to the Pacifica app.
Behavioral: Pacifica App
Participants will be placed on a wait list and will receive access to the app after 1 month.
The app contains several activities which are digital implementations of standard psychotherapy practices. Users may select which app elements they would like to use, and when. These app elements include relaxation and meditation activities, tools to examine your thoughts or self-talk, goal setting lists, and mood and health ratings. The app also has a peer support community where users can communicate with others who are having similar experiences. There is no minimum requirement for amount of time spent on any given activity, or in the app in total. The commercially available app has a feature to connect users to their existing healthcare providers, but this feature will not be available to study participants. Study participants may continue to see their existing providers.
Change in Depression
Change in Patient Health Questionnaire-8 (PHQ-8) score. Range is 0-24. Lower scores indicate less depression.
Time frame: 2 weeks, 1 month, 3 months
Change in Anxiety
Change in Generalized Anxiety Disorder-7 (GAD-7) score. Range is 0-19. Lower scores indicate less anxiety.
Time frame: 2 weeks, 1 month, 3 months
Change in Depression, Anxiety, Stress
Change in Depression Anxiety Stress Scale-21 (DASS-21) score. We will look at subscales. Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively. Lower scores indicate less severity.
Time frame: 2 weeks, 1 month, 3 months
Change in Self-Efficacy
Change in Score on General Self Efficacy Scale. Range is 10-40. Higher scores correspond to higher self-efficacy beliefs.
Time frame: 2 weeks, 1 month, 3 months
Plan to share: No — Individual data will not shared.
Ran from Nov 2017 to primary completion in May 2018, 6 months.
Of 98 industry-sponsored interventional studies with no phase under Depression, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 6 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 completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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