Positive Affect Regulation sKills at Northwestern University

Study Overview
=================
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.

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.

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

Conditions
-----------------
Anxiety, Depression, Social Isolation

Intervention / Treatment
-----------------
* Behavioral: Positive Emotion Skills Course


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive emotion skills invervention<br>Participants will go through a 6-week positive emotion skills course where 1 new skill opens each week. | Behavioral: Positive Emotion Skills Course<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety | Assessed using PROMIS Anxiety (CAT) | Baseline, 6 weeks, 6 months | 
| Change in depression | Assessed using PROMIS Depression (CAT) | Baseline, 6 weeks, 6 months | 
| Change in feelings of social isolation | Assessed using PROMIS Social Isolation (CAT) | Baseline, 6 weeks, 6 months | 
| Change in positive affect | Assessed using PROMIS Positive Affect (CAT) | Baseline, 6 weeks, 6 months | 
| Change in sense of meaning and purpose | Assessed using PROMIS Meaning and Purpose (CAT) | Baseline, 6 weeks, 6 months |