Overview

This trial is active, not recruiting.

Conditions depression, psychological stress, affect
Treatment positive affect skills training
Sponsor University of California, San Francisco
Start date July 2014
End date June 2016
Trial size 200 participants
Trial identifier NCT01964820, UCSF CHR 13-12256

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Participants receive a 5-week intervention providing training in 8 skills for generating positive affect.
positive affect skills training DAHLIA
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).
(No Intervention)
Participants report emotions on the same regular basis as intervention participants, but receive no intervention.

Primary Outcomes

Measure
Retention / feasibility
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)
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)
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 Outcomes

Measure
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)
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)
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)
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)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Daily internet access - Cell phone ownership - Score of 10 or greater on the PHQ-8 depression scale Exclusion Criteria:

Additional Information

Official title Online Positive Emotion Skills Intervention for Symptoms of Depression - Pilot Feasibility Trial
Principal investigator Judith T Moskowitz, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.