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Positive Affect Regulation sKills at Northwestern University (PARK-NU)

Primary Purpose

Anxiety, Depression, Social Isolation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Emotion Skills Course
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive emotion skills invervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change in anxiety
Assessed using PROMIS Anxiety (CAT)
Change in depression
Assessed using PROMIS Depression (CAT)
Change in feelings of social isolation
Assessed using PROMIS Social Isolation (CAT)
Change in positive affect
Assessed using PROMIS Positive Affect (CAT)
Change in sense of meaning and purpose
Assessed using PROMIS Meaning and Purpose (CAT)

Secondary Outcome Measures

Full Information

First Posted
April 27, 2020
Last Updated
September 29, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04367922
Brief Title
Positive Affect Regulation sKills at Northwestern University
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Social Isolation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive emotion skills invervention
Arm Type
Experimental
Arm Description
Participants will go through a 6-week positive emotion skills course where 1 new skill opens each week.
Intervention Type
Behavioral
Intervention Name(s)
Positive Emotion Skills Course
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
Assessed using PROMIS Anxiety (CAT)
Time Frame
Baseline, 6 weeks, 6 months
Title
Change in depression
Description
Assessed using PROMIS Depression (CAT)
Time Frame
Baseline, 6 weeks, 6 months
Title
Change in feelings of social isolation
Description
Assessed using PROMIS Social Isolation (CAT)
Time Frame
Baseline, 6 weeks, 6 months
Title
Change in positive affect
Description
Assessed using PROMIS Positive Affect (CAT)
Time Frame
Baseline, 6 weeks, 6 months
Title
Change in sense of meaning and purpose
Description
Assessed using PROMIS Meaning and Purpose (CAT)
Time Frame
Baseline, 6 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Moskowitz, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31757566
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.
Results Reference
background
PubMed Identifier
31302525
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.
Results Reference
background
PubMed Identifier
31045422
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.
Results Reference
background
PubMed Identifier
30701389
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.
Results Reference
background
PubMed Identifier
30260746
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.
Results Reference
background
PubMed Identifier
29871853
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.
Results Reference
background
PubMed Identifier
25214877
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.
Results Reference
background
PubMed Identifier
24113564
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.
Results Reference
background
PubMed Identifier
14744233
Citation
Folkman S, Moskowitz JT. Coping: pitfalls and promise. Annu Rev Psychol. 2004;55:745-74. doi: 10.1146/annurev.psych.55.090902.141456.
Results Reference
background
PubMed Identifier
36211530
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.
Results Reference
derived

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Positive Affect Regulation sKills at Northwestern University

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