AnxietyNCT03333707
Impact of a Mobile Application (Pacifica) on Stress, Anxiety, and Depression
A study testing Pacifica App in people with Anxiety and Stress, run by Pacifica Labs Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Stress, Depression
- What is being tested?
- Pacifica App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacifica Labs, Inc.
San Francisco, California, 94110
About this study
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.
Read the 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.
- Conditions
- Anxiety, Stress, Depression
- Being tested
- Pacifica App
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifica AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Participants will be provided will full access to the Pacifica app. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression
Change in Patient Health Questionnaire-8 (PHQ-8) score. Range is 0-24. Lower scores indicate less depression.
Measured: 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.
Measured: 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.
Measured: 2 weeks, 1 month, 3 months
Secondary outcomes (1)
Change in Self-Efficacy
Change in Score on General Self Efficacy Scale. Range is 10-40. Higher scores correspond to higher self-efficacy beliefs.
Measured: 2 weeks, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start2 Nov 2017
- Primary completion10 May 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacifica Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333707
- Sponsor's protocol ID
- Pacifica Study 1
- Status last verified
- May 2018
- First submitted
- 2 Nov 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not shared.
Publications
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.
PubMed 31199319
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mobile Application (Pacifica) on Stress, Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT03333707
- Acronym / sponsor ID
- Pacifica Study 1
- Conditions
- Anxiety, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Pacifica Labs Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Pacifica AppParticipants will be provided will full access to the Pacifica app. |
| Wait List | No intervention | –Participants will be placed on a wait list and will receive access to the app after 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Pacifica AppThe 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. | Behavioural | Active |
Primary outcome
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.
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.
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.
1 secondary outcome
Change in Self-Efficacy
Time frame: 2 weeks, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 31199319Moberg 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.
- Individual participant dataSharing planned: No. Individual data will not shared.
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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 Pacifica App in people with Anxiety and Stress, run by Pacifica Labs Inc. 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 5 inclusion and 2 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 17 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Depression (time frame: 2 weeks, 1 month, 3 months). The study lists 3 primary outcomes in all. 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 NCT03333707, 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 17 May 2018.