Positive Affect Regulation sKills at Northwestern University

Depression Clinical Trial

— PARK-NU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367922
• Other study ID #: STU00212262
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Social Isolation

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