Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964820
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) 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.

Condition or disease Intervention/treatment Phase
Depression Psychological Stress Affect Behavioral: Positive Affect Skills Training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Online Positive Emotion Skills Intervention for Symptoms of Depression - Pilot Feasibility Trial
Study Start Date : July 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964820


Locations
Layout table for location information
United States, California
University of California, San Francisco - Osher Center for Integrative Medicine
San Francisco, California, United States, 94143-1726
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Judith T Moskowitz, PhD University of California, San Francisco
Principal Investigator: Michael A Cohn, PhD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01964820    
Other Study ID Numbers: UCSF CHR 13-12256
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Stress, Psychological
 Behavioral Symptoms
Mood Disorders
Mental Disorders