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Impact of a Mobile Application (Pacifica) on Stress, Anxiety, and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333707
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pacifica Labs Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Stress Depression Behavioral: Pacifica App Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Mobile Application (Pacifica) on Stress, Anxiety, and Depression
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : May 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active
Participants will be provided will full access to the Pacifica app.
Behavioral: Pacifica App
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.

No Intervention: Wait List
Participants will be placed on a wait list and will receive access to the app after 1 month.



Primary Outcome Measures :
  1. Change in Depression [ Time Frame: 2 weeks, 1 month, 3 months ]
    Change in Patient Health Questionnaire-8 (PHQ-8) score. Range is 0-24. Lower scores indicate less depression.

  2. Change in Anxiety [ Time Frame: 2 weeks, 1 month, 3 months ]
    Change in Generalized Anxiety Disorder-7 (GAD-7) score. Range is 0-19. Lower scores indicate less anxiety.

  3. Change in Depression, Anxiety, Stress [ Time Frame: 2 weeks, 1 month, 3 months ]
    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.


Secondary Outcome Measures :
  1. Change in Self-Efficacy [ Time Frame: 2 weeks, 1 month, 3 months ]
    Change in Score on General Self Efficacy Scale. Range is 10-40. Higher scores correspond to higher self-efficacy beliefs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Target disease: participants who score between 5 and 14 on the GAD-7 OR between 5 and 14 on the PHQ-8 and are therefore believed to be experience mild to moderate depression or anxiety
  • No previous experience using the Pacifica app.
  • Regular access to a smartphone
  • Fluent in English
  • Living in U.S.

Exclusion Criteria:

  • Below 5 or over 14 on GAD-7 or below 5 or over 14 on PHQ-8
  • Positive response on screener of presence of diagnosis of bipolar disorder, schizophrenia, other psychotic spectrum disorder, organic brain disease, currently pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333707


Locations
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United States, California
Pacifica Labs, Inc.
San Francisco, California, United States, 94110
Sponsors and Collaborators
Pacifica Labs Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pacifica Labs Inc.
ClinicalTrials.gov Identifier: NCT03333707    
Other Study ID Numbers: Pacifica Study 1
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders