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Completed

NCT Number: NCT01964820

Online Positive Emotion Skills Intervention for Symptoms of Depression

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) Measure heart rate variability and emotions using existing smartphone software; and 3) Perform a randomized pilot trial of the mobile intervention on individuals with clinical depression recruited online.

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Key information

Conditions

Depression Affect Behavior Behavioral Symptoms Psychological Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco - Osher Center for Integrative Medicine

San Francisco, California, 94143-1726, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Daily internet access
  • Cell phone ownership
  • Score of 10 or greater on the PHQ-8 depression scale

Exclusion criteria

-

Treatment and study plan

Positive Affect Skills Training

Behavioral

Our intervention teaches 8 skills that research suggests lead to increased positive emotions, beginning with basic skills (recognizing and savoring positive events), and progressing to more complex ones such as goal- setting and acts of kindness. Established skills such as reappraising negative thoughts are also taught, in the context of cultivating positive emotions and coping with stress.

The skills are taught over 5 weeks, with one or more new skills introduced each week. A week consists of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting.

For a full description, see "A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test" (Moskowitz et al., 2012).

Other names: DAHLIA, MARIGOLD

Primary outcomes

  1. Retention / feasibility

    Time frame: 3 months after completion of intervention (5 months post-enrollment, may be slightly more or less for intervention participants depending on time taken to complete the course)

    Determine percentage of participants providing data at each stage of the study (intervention phase, post-intervention, 1 month followup, 3 month followup)

  2. Depression symptoms (PHQ-9 questionnaire)

    Time frame: 60 days after enrollment (administered immediately post-intervention, may be slightly more or less than 60 days for intervention participants depending on time taken to complete the course)

  3. Depression symptoms (CES-D questionnaire)

    Time frame: 60 days after enrollment (administered immediately post-intervention, may be slightly more or less than 60 days for intervention participants depending on time taken to complete the course)

Secondary outcomes

  1. Perceived Stress (PSS questionnaire)

    Time frame: 60 days after enrollment (administered immediately post-intervention, may be slightly more or less than 60 days for intervention participants depending on time taken to complete the course)

  2. Positive and Negative affect (DES questionnaire)

    Time frame: 60 days after enrollment (administered immediately post-intervention, may be slightly more or less than 60 days for intervention participants depending on time taken to complete the course)

  3. Depression symptoms at follow-up (CESD questionnaire)

    Time frame: 3 months after completion of intervention (5 months post-enrollment, may be slightly more or less for intervention participants depending on time taken to complete the course)

  4. Depression symptoms at follow-up (PHQ-9 questionnaire)

    Time frame: 3 months after completion of intervention (5 months post-enrollment, may be slightly more or less for intervention participants depending on time taken to complete the course)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Online Positive Emotion Skills Intervention for Symptoms of Depression - Pilot Feasibility Trial

Acronym: MARIGOLD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2013
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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