Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
Primary Purpose
Depression, Psychological Stress, Affect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Affect Skills Training
Sponsored by
About this trial
This is an interventional supportive care trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Daily internet access
- Cell phone ownership
- Score of 10 or greater on the PHQ-8 depression scale
Exclusion Criteria:
-
Sites / Locations
- University of California, San Francisco - Osher Center for Integrative Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Positive affect skills intervention
Emotion reporting
Arm Description
Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.
Participants report emotions on the same regular basis as intervention participants, but receive no intervention.
Outcomes
Primary Outcome Measures
Retention / feasibility
Determine percentage of participants providing data at each stage of the study (intervention phase, post-intervention, 1 month followup, 3 month followup)
Depression symptoms (PHQ-9 questionnaire)
Depression symptoms (CES-D questionnaire)
Secondary Outcome Measures
Perceived Stress (PSS questionnaire)
Positive and Negative affect (DES questionnaire)
Depression symptoms at follow-up (CESD questionnaire)
Depression symptoms at follow-up (PHQ-9 questionnaire)
Full Information
NCT ID
NCT01964820
First Posted
October 10, 2013
Last Updated
December 29, 2017
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01964820
Brief Title
Online Positive Emotion Skills Intervention for Symptoms of Depression
Acronym
MARIGOLD
Official Title
Online Positive Emotion Skills Intervention for Symptoms of Depression - Pilot Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Psychological Stress, Affect
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive affect skills intervention
Arm Type
Experimental
Arm Description
Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.
Arm Title
Emotion reporting
Arm Type
No Intervention
Arm Description
Participants report emotions on the same regular basis as intervention participants, but receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Positive Affect Skills Training
Other Intervention Name(s)
DAHLIA, MARIGOLD
Intervention Description
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).
Primary Outcome Measure Information:
Title
Retention / feasibility
Description
Determine percentage of participants providing data at each stage of the study (intervention phase, post-intervention, 1 month followup, 3 month followup)
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)
Title
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)
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Daily internet access
Cell phone ownership
Score of 10 or greater on the PHQ-8 depression scale
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith T Moskowitz, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Cohn, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco - Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1726
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22021272
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.
Results Reference
background
PubMed Identifier
29871853
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.
Results Reference
derived
Learn more about this trial
Online Positive Emotion Skills Intervention for Symptoms of Depression
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