Online Positive Emotion Skills Intervention for Symptoms of Depression

Study Overview
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Brief Summary
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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

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

Conditions
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Depression, Psychological Stress, Affect

Intervention / Treatment
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* Behavioral: Positive Affect Skills Training
* Behavioral: 5-week Emotion Reporting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.<br>|
| Experimental: Arm 2<br>Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course. | Behavioral: 5-week Emotion Reporting<br> <br> |

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Depressive Disorder, Psychological Stress, Behavioral Symptoms, Mental Disorders, Mood Disorders