Clinical trial NCT04367922: Positive Affect Regulation sKills at Northwestern University
Official title: A Positive Affect Regulation sKills Intervention to Decrease Stress During a Pandemic: A Single Arm, Non-Randomized Trial of a Public Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Social Isolation
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in depression
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in feelings of social isolation
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in positive affect
timeFrame: Baseline, 6 weeks, 6 months
measure: Change in sense of meaning and purpose
timeFrame: Baseline, 6 weeks, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskowitz JT, Addington EL, Cheung EO. Positive psychology and health: Well-being interventions in the context of illness. Gen Hosp Psychiatry. 2019 Nov-Dec;61:136-138. doi: 10.1016/j.genhosppsych.2019.11.001. Epub 2019 Nov 8. No abstract available.
citation: Addington EL, Cheung EO, Bassett SM, Kwok I, Schuette SA, Shiu E, Yang D, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. The MARIGOLD study: Feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms. J Affect Disord. 2019 Oct 1;257:352-364. doi: 10.1016/j.jad.2019.07.049. Epub 2019 Jul 5.
citation: Moskowitz JT, Cheung EO, Snowberg KE, Verstaen A, Merrilees J, Salsman JM, Dowling GA. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019 May;38(5):391-402. doi: 10.1037/hea0000680.
citation: Bassett SM, Cohn M, Cotten P, Kwok I, Moskowitz JT. Feasibility and Acceptability of an Online Positive Affect Intervention for Those Living with Comorbid HIV Depression. AIDS Behav. 2019 Mar;23(3):753-764. doi: 10.1007/s10461-019-02412-z.
citation: Pressman SD, Jenkins BN, Moskowitz JT. Positive Affect and Health: What Do We Know and Where Next Should We Go? Annu Rev Psychol. 2019 Jan 4;70:627-650. doi: 10.1146/annurev-psych-010418-102955. Epub 2018 Sep 27.
citation: Cheung EO, Addington EL, Bassett SM, Schuette SA, Shiu EW, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD. JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.
citation: Cohn MA, Pietrucha ME, Saslow LR, Hult JR, Moskowitz JT. An online positive affect skills intervention reduces depression in adults with type 2 diabetes. J Posit Psychol. 2014 Jan 1;9(6):523-534. doi: 10.1080/17439760.2014.920410.
citation: Dowling GA, Merrilees J, Mastick J, Chang VY, Hubbard E, Moskowitz JT. Life enhancing activities for family caregivers of people with frontotemporal dementia. Alzheimer Dis Assoc Disord. 2014 Apr-Jun;28(2):175-81. doi: 10.1097/WAD.0b013e3182a6b905.
citation: Folkman S, Moskowitz JT. Coping: pitfalls and promise. Annu Rev Psychol. 2004;55:745-74. doi: 10.1146/annurev.psych.55.090902.141456.
citation: Addington EL, Cummings P, Jackson K, Yang D, Moskowitz JT. Exploring Retention, Usage, and Efficacy of Web-Based Delivery of Positive Emotion Regulation Skills During the COVID-19 Pandemic. Affect Sci. 2022 Oct 4;4(1):118-130. doi: 10.1007/s42761-022-00135-4. eCollection 2023 Mar.