Online Positive Emotion Skills Intervention for Symptoms of Depression

NCT01964820 | Completed

• 1 other identifier: UCSF CHR 13-12256
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Psychological Stress; Affect

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Positive affect skills intervention

EXPERIMENTAL

Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.

Behavioral: Positive Affect Skills Training

Emotion reporting

NO INTERVENTION

Participants report emotions on the same regular basis as intervention participants, but receive no intervention.

Interventions

Positive Affect Skills Training BEHAVIORAL

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).

Also known as: DAHLIA, MARIGOLD

Positive affect skills intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco - Osher Center for Integrative Medicine

San Francisco, California, 94143-1726, United States

Location

Related Publications (2)

• 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.

  PMID: 22021272 BACKGROUND

• 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.

  PMID: 29871853 DERIVED

MeSH Terms

Conditions

Depression; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Judith T Moskowitz, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Michael A Cohn, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

US (1)