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Completed

NCT Number: NCT04367922

Positive Affect Regulation sKills at Northwestern University

The Positive Affect Regulation sKills (PARK) Course is an online program containing a series of positive emotion skills for individuals experiencing stress and distress as a result of COVID-19 and the return to "normal." The study specifically targets positive emotion, and offers an array of skills in a self-guided online delivery platform, making the program accessible and convenient in confusing and stressful times.

Our main aims are:

Aim 1: To explore the effects of PARK on anxiety, depression, feelings of social isolation, positive affect, and a sense of meaning and purpose.

Aim 2: To test whether age or gender moderate the effects of the program.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Social Behavior Social Isolation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

The goal of the proposed program, PARK, is to reduce feelings of anxiety, depression, and social isolation, as well as increase well-being and a sense of meaning and purpose through the practice of positive emotion skills via a self-guided online platform. We will compare baseline scores on PROMIS measures of Anxiety, Depression, Social Isolation, Meaning and Purpose, and Positive Emotion to scores after completing the online course (approximately 8 weeks later), and again at 6 months post-baseline.

Research will be based in Northwestern's Feinberg School of Medicine through the Department of Medical Social Sciences (MSS), with all study procedures conducted online. Eligibility screening, consent, and assessments will be conducted on REDCap. For the positive skills course (including weekly lessons and daily skills practice) and daily emotion check-ins, consenting participants will receive access to the online PARK platform, hosted by BrightOutcome.

The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Speaks and reads English
  • Able to access the online platform through their phone, a public device (i.e., at the library) or at home.
  • Lives in US

Exclusion criteria

  • Inability to communicate in English
  • Lives outside the US
  • Under 18 years of age

Treatment and study plan

Positive Emotion Skills Course

Behavioral

The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access. A week will consist of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting. Participants cannot skip ahead, and can only progress to the next lesson if they have completed the current one, but they can return to old lessons or exercises if they wish to. Skills include: positive events, capitalizing, gratitude, mindfulness, positive reappraisal, personal strengths, achievable goals, self-compassion.

Primary outcomes

  1. Change in anxiety

    Time frame: Baseline, 6 weeks, 6 months

    Assessed using PROMIS Anxiety (CAT)

  2. Change in depression

    Time frame: Baseline, 6 weeks, 6 months

    Assessed using PROMIS Depression (CAT)

  3. Change in feelings of social isolation

    Time frame: Baseline, 6 weeks, 6 months

    Assessed using PROMIS Social Isolation (CAT)

  4. Change in positive affect

    Time frame: Baseline, 6 weeks, 6 months

    Assessed using PROMIS Positive Affect (CAT)

  5. Change in sense of meaning and purpose

    Time frame: Baseline, 6 weeks, 6 months

    Assessed using PROMIS Meaning and Purpose (CAT)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Positive Affect Regulation sKills Intervention to Decrease Stress During a Pandemic: A Single Arm, Non-Randomized Trial of a Public Platform

Acronym: PARK-NU

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2020
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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