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

NCT03333707 | Completed DMC

• 1 other identifier: Pacifica Study 1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress; Depression

Outcome Measures

Primary Outcomes (3)

• Change in Depression

  Change in Patient Health Questionnaire-8 (PHQ-8) score. Range is 0-24. Lower scores indicate less depression.

  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.

  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.

  2 weeks, 1 month, 3 months

Secondary Outcomes (1)

• Change in Self-Efficacy

  2 weeks, 1 month, 3 months

Study Arms (2)

Active

EXPERIMENTAL

Participants will be provided will full access to the Pacifica app.

Behavioral: Pacifica App

Wait List

NO INTERVENTION

Participants will be placed on a wait list and will receive access to the app after 1 month.

Interventions

Pacifica App BEHAVIORAL

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.

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacifica Labs Inc.: lead

Study Sites (1)

Pacifica Labs, Inc.

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Moberg C, Niles A, Beermann D. Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression. J Med Internet Res. 2019 Jun 8;21(6):e12556. doi: 10.2196/12556.

  PMID: 31199319 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 7, 2017
• Study Start: November 2, 2017
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)