Online Positive Emotion Skills Intervention for Symptoms of Depression
- Conditions
- AffectDepressionPsychological Stress
- Interventions
- Behavioral: Positive Affect Skills TrainingBehavioral: 5-week Emotion Reporting
- Registration Number
- NCT02861755
- Lead Sponsor
- Northwestern University
- 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) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 677
- Daily internet access
- Cell phone ownership
- Score of 5 or higher on PHQ-8 scale
- Lives in US or Canada
- Speaks and reads English, able to provide informed consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Positive Affect Skills Training The MARIGOLD positive emotions course plus a blend of enhancements to include: 5-minutes of weekly facilitator contact, online discussion board, or gamification through virtual flower badges. Arm 2 5-week Emotion Reporting Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course.
- Primary Outcome Measures
Name Time Method Change in Retention Over Time (average of 4.5 months through study completion) From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study. Determine the percentage of participants providing data at each stage of the study from baseline to study completion (average of 4.5 months). This includes capturing dropout rates and reasons for dropping out, where possible; Retention will also include analyzing any qualitative comments/feedback on the lessons and home practice exercises in order to gauge what participants like and don't like, and what is feasible for future iterations of this study to maximize retention.
Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 8-items; responses range from 0 "not at all" to 3 "almost every day"
Change in Depression symptoms (CES-D questionnaire) Over Time From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 20-items; responses range from 1 "rarely or none of the time (less than 1 day)" to 3 "occasionally or a moderate amount of the time (3-4 days)"
- Secondary Outcome Measures
Name Time Method Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 6-items of self-reported resilience; responses range from 1 "strongly disagree" to 5 "strongly agree"
Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week") From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 26-items; responses range from 1 "not at all" to 9 "all the time"; framed as "Over the PAST week, how much have you felt each of these emotions?"
Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 7-items; responses range from 1 "never or rarely true" to 5 "very often or always true"
Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 10-items; responses range from 1 "never" to 5 "very often"
Change in Meaning and Purpose Scale over time (4.5 months of participation in the study) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 8-item scale with 5 response options ranging from "strongly disagree" to "strongly agree"
Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 9-item scale measuring positive affect and well-being with 5 response options: "never" "rarely" "sometimes" "often" "always"
Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 10-items; responses range from 1 "definitely false" to 5 "definitely true"
Change in General Behavior Inventory (GBI) Scale From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 7-item instrument assessing for symptoms of mania with 7 response options: 0 "Never or hardly ever," 1 "Sometimes," 2 "Often," 3 "Very Often," 7 "Don't Know," 8 "Refuse to Answer," 9 "Not applicable." The 7 items include questions such as: "Have there been times lasting several days or more when you felt you must have lots of excitement, and you actually did a lot of new or different things?"
Change in Stress Management Self-Efficacy (SMSE) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 4-item instrument that measures the impact of stress on depressive symptoms. Response scale ranges from 1 "strongly agree" to 4 "strongly disagree." Items include: 1) I believe I have the ability to cope with the demands of my life 2) I know when I'm starting to experience too much stress 3) I know how to cope with stress when it comes and 4) I am usually able to successfully deal with my stress levels.
Expectancy Credibility Scale Administered once at the initial questionnaire prior to Week 1 of the intervention. 6-item instrument that measures how expectancy and credibility might influence participants' responses. Responses range from 1 "Not at all" to 9 "Very." Statements include: "At this point, how logical does this course seem to you?" or "At this point, how much do you really feel that the course will help you to improve your functioning?"
Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 6-items; responses range from 1 "disagree strongly" to 9 "agree strongly"
Change in Behavioral Activation for Depression Scale (BADS) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 9-item instrument that measures the impact of behavioral activation on depressive symptoms. Response items range from 0 to 6, from "Not at all" to "Completely." Statements include: "I was an active person and accomplished the goals I set out to do" and "I did things that were enjoyable."
Change in Self-Stigma Depression Scale (SSDS) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 16-item instrument that assesses levels of self-stigma surrounding depressive symptoms. This measure will be used to replace the DSSS from the pilot phase of the study.
Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study) From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 32-item scale to measure self stigma of depression; responses range from 1 "completely disagree" to 7 "completely agree"
Change in Self Compassion Scale (SCS) Short-Form From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). 12-item instrument assesses levels of self-compassion. Response items range from 1 "Almost never" to 5 "Almost always." Statements include: "I try to see my failings as part of the human condition" and "When something painful happens I try to take a balanced view of the situation."
Trial Locations
- Locations (1)
Northwestern University, Feinberg School of Medicine, MSS Dept
🇺🇸Chicago, Illinois, United States