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

December 29, 2017 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-1726
        • University of California, San Francisco - Osher Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive affect skills intervention
Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.
Behavioral: Positive Affect Skills Training

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
No Intervention: Emotion reporting
Participants report emotions on the same regular basis as intervention participants, but receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Judith T Moskowitz, PhD, University of California, San Francisco
  • Principal Investigator: Michael A Cohn, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSF CHR 13-12256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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