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

Depression, Depressive Disorder, Psychological Stress, Behavioral Symptoms, Mental Disorders, Mood Disorders

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.

Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course.

Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.

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.

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).

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).

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).

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).

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).

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)

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).

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).

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).

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).

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).

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).

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).

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).

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?"

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).

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).

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).

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).

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).

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).

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)

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)

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).

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).

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"

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.

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).

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

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.

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.

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.