Clinical trial NCT01964820: Online Positive Emotion Skills Intervention for Symptoms of Depression
Official title: Online Positive Emotion Skills Intervention for Symptoms of Depression - Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Psychological Stress
Affect
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Retention / feasibility
timeFrame: 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)
measure: Depression symptoms (PHQ-9 questionnaire)
timeFrame: 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)
measure: Depression symptoms (CES-D questionnaire)
timeFrame: 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:
measure: Perceived Stress (PSS questionnaire)
timeFrame: 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)
measure: Positive and Negative affect (DES questionnaire)
timeFrame: 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)
measure: Depression symptoms at follow-up (CESD questionnaire)
timeFrame: 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)
measure: Depression symptoms at follow-up (PHQ-9 questionnaire)
timeFrame: 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)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco - Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith T Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Michael A Cohn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.