Online Positive Emotion Skills Intervention for Symptoms of Depression

Not Applicable

Completed

• Conditions: Depression; Psychological Stress; Affect
• Interventions: Behavioral: Positive Affect Skills Training

• Registration Number: NCT01964820
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Study Start: 2014-07
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive affect skills intervention	Positive Affect Skills Training	Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.

Primary Outcome Measures

Name	Time	Method
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)
Retention / feasibility	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)
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)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

University of California, San Francisco - Osher Center for Integrative Medicine; 🇺🇸 San Francisco, California, United States