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

Northwestern University

Status: Completed

Conditions: Psychological Stress; Affect; Depression

Treatments: Behavioral: 5-week Emotion Reporting; Behavioral: Positive Affect Skills Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02861755

R34MH101265-02 (U.S. NIH Grant/Contract)

STU00092507

Details and patient eligibility

About

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

Enrollment: 677 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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677 participants in 2 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Affect Skills Training

Arm 2

Experimental group

Description:

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

Treatment:

Behavioral: 5-week Emotion Reporting