Clinical trial NCT02861755: Online Positive Emotion Skills Intervention for Symptoms of Depression
Official title: Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Psychological Stress
Affect
Keywords: Depression
Depressive Disorder
Psychological Stress
Behavioral Symptoms
Mental Disorders
Mood Disorders
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute of Mental Health (NIMH)
First posted: 2016-08-10
Enrollment: 677
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Retention Over Time (average of 4.5 months through study completion)
timeFrame: 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.
measure: Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)
timeFrame: 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).
measure: Change in Depression symptoms (CES-D questionnaire) Over Time
timeFrame: 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 outcomes:
measure: Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time
timeFrame: 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).
measure: Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week")
timeFrame: 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).
measure: Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 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).
measure: Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale)
timeFrame: 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).
measure: Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months)
timeFrame: 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).
measure: Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study)
timeFrame: 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).
measure: Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study)
timeFrame: 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).
measure: Change in Meaning and Purpose Scale over time (4.5 months of participation in the study)
timeFrame: 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).
measure: Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank
timeFrame: 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).
measure: Change in General Behavior Inventory (GBI) Scale
timeFrame: 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).
measure: Change in Behavioral Activation for Depression Scale (BADS)
timeFrame: 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).
measure: Change in Stress Management Self-Efficacy (SMSE)
timeFrame: 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).
measure: Expectancy Credibility Scale
timeFrame: Administered once at the initial questionnaire prior to Week 1 of the intervention.
measure: Change in Self Compassion Scale (SCS) Short-Form
timeFrame: 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).
measure: Change in Self-Stigma Depression Scale (SSDS)
timeFrame: 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 outcomes:
measure: Change in Life Satisfaction Scale
timeFrame: 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).
measure: Change in Burnout Scale
timeFrame: 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).
measure: Change in Importance of Happiness (1-item measure)
timeFrame: 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).
measure: Change in Personality Scale
timeFrame: 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).
measure: Change in Daily Inventory of Stressful Events (DISE) Self-Assessment over 5 weeks (daily)
timeFrame: Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5)
measure: Change in Differential Emotions Scale (DES) over 5 weeks (daily)
timeFrame: Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5)
measure: Change in self-reported mental health status
timeFrame: 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).
measure: Change in Happiness Inducing Behavior (HIB) Scale
timeFrame: 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).
measure: Change in Situational Motivation Scale (SIMS)
timeFrame: Post-intervention (Week 6), 1 month followup (Week 10), and 3 month followup (Week 18) only
measure: Technology Survey
timeFrame: Administered only at baseline (Week 1) and post-intervention (Week 6).
measure: Change in Pain
timeFrame: 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).
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine, MSS Dept
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith T Moskowitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.