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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04367922
Other study ID # STU00212262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2020
Est. completion date December 31, 2023

Study information

Verified date April 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Folkman S, Moskowitz JT. Coping: pitfalls and promise. Annu Rev Psychol. 2004;55:745-74. doi: 10.1146/annurev.psych.55.090902.141456. — View 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. — View 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. — View 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. — View Citation

Outcome

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