Online Positive Emotion Skills Intervention for Symptoms of Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Psychological Stress, Affect

Intervention / Treatment
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* Behavioral: Positive Affect Skills Training


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive affect skills intervention<br>Participants receive a 5-week intervention providing training in 8 skills for generating positive affect. | Behavioral: Positive Affect Skills Training<br>* 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).<br>* Other names: MARIGOLD;|
| No Intervention: Emotion reporting<br>Participants report emotions on the same regular basis as intervention participants, but receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |