PARK-NU: Positive Affect Regulation sKills at Northwestern University

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04367922
Collaborator
(none)
1,000
1
1
34.1
29.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Positive Emotion Skills Course
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Positive Affect Regulation sKills Intervention to Decrease Stress During a Pandemic: A Single Arm, Non-Randomized Trial of a Public Platform
Actual Study Start Date :
Apr 27, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Positive emotion skills invervention

Participants will go through a 6-week positive emotion skills course where 1 new skill opens each week.

Behavioral: Positive Emotion Skills Course
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.

Outcome Measures

Primary Outcome Measures

  1. Change in anxiety [Baseline, 6 weeks, 6 months]

    Assessed using PROMIS Anxiety (CAT)

  2. Change in depression [Baseline, 6 weeks, 6 months]

    Assessed using PROMIS Depression (CAT)

  3. Change in feelings of social isolation [Baseline, 6 weeks, 6 months]

    Assessed using PROMIS Social Isolation (CAT)

  4. Change in positive affect [Baseline, 6 weeks, 6 months]

    Assessed using PROMIS Positive Affect (CAT)

  5. Change in sense of meaning and purpose [Baseline, 6 weeks, 6 months]

    Assessed using PROMIS Meaning and Purpose (CAT)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60625

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Judith Moskowitz, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Judith Moskowitz, Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT04367922
Other Study ID Numbers:
  • STU00212262
First Posted:
Apr 29, 2020
Last Update Posted:
Mar 7, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022