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临床试验/NCT03333707
NCT03333707已完成不适用

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

Pacifica Labs Inc.2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
Change in Anxiety

研究概览

简要总结

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.

详细描述

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".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Active

Experimental

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

干预措施: Pacifica App (Behavioral)

Wait List

No Intervention

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

结局指标

主要结局

Change in Anxiety

时间窗: 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

时间窗: 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.

Change in Depression

时间窗: 2 weeks, 1 month, 3 months

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

次要结局

  • Change in Self-Efficacy(2 weeks, 1 month, 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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