Online Positive Emotion Skills Intervention for Symptoms of Depression

Depression Clinical Trial

— MARIGOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861755
• Other study ID #: STU00092507
• Secondary ID: R34MH101265-02
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affect
• Depression
• Depressive Disorder
• Psychological Stress
• Stress, Psychological

Intervention

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.
• 5-week Emotion Reporting

Locations

Country	Name	City	State
United States	Northwestern University, Feinberg School of Medicine, MSS Dept	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH), University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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).
Other	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).
Other	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).
Other	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)
Other	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)
Other	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).
Other	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).
Other	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
Other	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).
Other	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).
Primary	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.
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.
Secondary	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).
Secondary	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).