Online Positive Emotion Skills Intervention for Symptoms of Depression

Depression Clinical Trial

— MARIGOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964820
• Other study ID #: UCSF CHR 13-12256
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: December 29, 2017
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Daily internet access

• Cell phone ownership

• Score of 10 or greater on the PHQ-8 depression scale

Exclusion Criteria:

Related Conditions & MeSH terms

• Affect
• Depression
• Depressive Disorder
• Psychological Stress
• Stress, Psychological

Intervention

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).

Locations

Country	Name	City	State
United States	University of California, San Francisco - Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention / feasibility	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)
Primary	Depression symptoms (PHQ-9 questionnaire)		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)
Primary	Depression symptoms (CES-D questionnaire)		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	Perceived Stress (PSS questionnaire)		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	Positive and Negative affect (DES questionnaire)		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	Depression symptoms at follow-up (CESD questionnaire)		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)
Secondary	Depression symptoms at follow-up (PHQ-9 questionnaire)		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)