Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)

Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)

Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. In this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. The study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. The aims are: 1) Retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale

Study Overview

• Status: Completed
• Conditions: Depression; Psychological Stress; Affect
• Intervention / Treatment: Behavioral: Positive Affect Skills Training; Behavioral: 5-week Emotion Reporting

• Study Type: Interventional
• Enrollment (Actual): 677
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Feinberg School of Medicine, MSS Dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Daily internet access
• Cell phone ownership
• Score of 5 or higher on PHQ-8 scale
• Lives in US or Canada
• Speaks and reads English, able to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; The MARIGOLD positive emotions course plus a blend of enhancements to include: 5-minutes of weekly facilitator contact, online discussion board, or gamification through virtual flower badges.	Behavioral: Positive Affect Skills Training; Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.
Experimental: Arm 2; Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course.	Behavioral: 5-week Emotion Reporting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Retention Over Time (average of 4.5 months through study completion)	Determine the percentage of participants providing data at each stage of the study from baseline to study completion (average of 4.5 months). This includes capturing dropout rates and reasons for dropping out, where possible; Retention will also include analyzing any qualitative comments/feedback on the lessons and home practice exercises in order to gauge what participants like and don't like, and what is feasible for future iterations of this study to maximize retention.	From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study.
Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)	8-items; responses range from 0 "not at all" to 3 "almost every day"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Depression symptoms (CES-D questionnaire) Over Time	20-items; responses range from 1 "rarely or none of the time (less than 1 day)" to 3 "occasionally or a moderate amount of the time (3-4 days)"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time	10-items; responses range from 1 "never" to 5 "very often"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week")	26-items; responses range from 1 "not at all" to 9 "all the time"; framed as "Over the PAST week, how much have you felt each of these emotions?"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ)	7-items; responses range from 1 "never or rarely true" to 5 "very often or always true"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale)	6-items; responses range from 1 "disagree strongly" to 9 "agree strongly"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months)	10-items; responses range from 1 "definitely false" to 5 "definitely true"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study)	6-items of self-reported resilience; responses range from 1 "strongly disagree" to 5 "strongly agree"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study)	32-item scale to measure self stigma of depression; responses range from 1 "completely disagree" to 7 "completely agree"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Meaning and Purpose Scale over time (4.5 months of participation in the study)	8-item scale with 5 response options ranging from "strongly disagree" to "strongly agree"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank	9-item scale measuring positive affect and well-being with 5 response options: "never" "rarely" "sometimes" "often" "always"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in General Behavior Inventory (GBI) Scale	7-item instrument assessing for symptoms of mania with 7 response options: 0 "Never or hardly ever," 1 "Sometimes," 2 "Often," 3 "Very Often," 7 "Don't Know," 8 "Refuse to Answer," 9 "Not applicable." The 7 items include questions such as: "Have there been times lasting several days or more when you felt you must have lots of excitement, and you actually did a lot of new or different things?"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Behavioral Activation for Depression Scale (BADS)	9-item instrument that measures the impact of behavioral activation on depressive symptoms. Response items range from 0 to 6, from "Not at all" to "Completely." Statements include: "I was an active person and accomplished the goals I set out to do" and "I did things that were enjoyable."	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Stress Management Self-Efficacy (SMSE)	4-item instrument that measures the impact of stress on depressive symptoms. Response scale ranges from 1 "strongly agree" to 4 "strongly disagree." Items include: 1) I believe I have the ability to cope with the demands of my life 2) I know when I'm starting to experience too much stress 3) I know how to cope with stress when it comes and 4) I am usually able to successfully deal with my stress levels.	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Expectancy Credibility Scale	6-item instrument that measures how expectancy and credibility might influence participants' responses. Responses range from 1 "Not at all" to 9 "Very." Statements include: "At this point, how logical does this course seem to you?" or "At this point, how much do you really feel that the course will help you to improve your functioning?"	Administered once at the initial questionnaire prior to Week 1 of the intervention.
Change in Self Compassion Scale (SCS) Short-Form	12-item instrument assesses levels of self-compassion. Response items range from 1 "Almost never" to 5 "Almost always." Statements include: "I try to see my failings as part of the human condition" and "When something painful happens I try to take a balanced view of the situation."	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Self-Stigma Depression Scale (SSDS)	16-item instrument that assesses levels of self-stigma surrounding depressive symptoms. This measure will be used to replace the DSSS from the pilot phase of the study.	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Life Satisfaction Scale	ratings of life, job, relationship on a 9-point scale, from 1 "not satisfied" to 9 "satisfied"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Burnout Scale	rating health and sleep quality on a 9-point scale from 1 "poor" to 9 "excellent"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Importance of Happiness (1-item measure)	1 item measure on a 9-point scale ranging from 1 "not very important" to 9 "very important"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Personality Scale	self-rated personality for dependability/discipline and disorganization/carelessness on a 9-point scale from 1 "strongly disagree" to 9 "strongly agree."	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Daily Inventory of Stressful Events (DISE) Self-Assessment over 5 weeks (daily)	7-items measuring stressful events with 5 response items ranging from 0 "didn't happen" to 4 "very stressful"	Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5)
Change in Differential Emotions Scale (DES) over 5 weeks (daily)	26-items; responses range from 1 "not at all" to 9 "all the time"; framed as "Over the PAST day, how much have you felt each of these emotions?"	Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5)
Change in self-reported mental health status	6 self-report questions asking about depression diagnosis, medication, therapies, treatment. For example, "Have you ever taken medication for anxiety, worry, or stress?" with options such as "I'm currently taking medication" "In the past, but not now" and "No."	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Happiness Inducing Behavior (HIB) Scale	38-items assessing how often repondents have completed happiness inducing behaviors. Adapted scale and 7 response options range from "Not at all" to "Multiple Times a Day"	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Situational Motivation Scale (SIMS)	16-items assessing what motivates a respondent to use the MARIGOLD skills with 7 response options ranging from 1 "Not at all" to 7 "Exactly"	Post-intervention (Week 6), 1 month followup (Week 10), and 3 month followup (Week 18) only
Technology Survey	6-items administered at baseline to assess level of technology use, modes of use, and frequency of use. 1-item technology question at post-intervention asking which device participants used the most for MARIGOLD.	Administered only at baseline (Week 1) and post-intervention (Week 6).
Change in Pain	Single-Item pain measure assessed at each timepoint to measure change in pain level. Asks about the average level of pain over the past week on a scale of 0 to 10, with 0 being "No pain" and 10 being "Pain as bad as you can imagine."	From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Francisco
• Investigators: Principal Investigator: Judith T Moskowitz, PhD, MPH, Northwestern University

Publications and helpful links

General Publications

• Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.
• 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.
• Moskowitz JT, Addington EL, Shiu E, Bassett SM, Schuette S, Kwok I, Freedman ME, Leykin Y, Saslow LR, Cohn MA, Cheung EO. Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e25922. doi: 10.2196/25922.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimated): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Mood Disorders; Depressive Disorder; Mental Disorders; Behavioral Symptoms; Psychological Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Stress, Psychological
• Other Study ID Numbers: STU00092507; R34MH101265-02 (U.S. NIH Grant/Contract)