Affect, Depression, Psychological Stress
Conditions
Keywords
Depression, Depressive Disorder, Psychological Stress, Behavioral Symptoms, Mental Disorders, Mood Disorders
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
Interventions
BEHAVIORALPositive Affect Skills Training
Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.
BEHAVIORAL5-week Emotion Reporting
Sponsors
University of California, San Francisco
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 |
| 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 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 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 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. |
| 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 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Inventory of Stressful Events (DISE) Self-Assessment over 5 weeks (daily) | Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5) | 7-items measuring stressful events with 5 response items ranging from 0 didn't happen to 4 very stressful |
| Change in Differential Emotions Scale (DES) over 5 weeks (daily) | Starts at the onset of the 5-week intervention (Week 1) and continues throughout the 5 weeks on a daily basis (through Week 5) | 26-items; responses range from 1 not at all to 9 all the time; framed as Over the PAST day, how much have you felt each of these emotions? |
| Change in self-reported mental health status | 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 self-report questions asking about depression diagnosis, medication, therapies, treatment. For example, Have you ever taken medication for anxiety, worry, or stress? with options such as I'm currently taking medication In the past, but not now and No. |
| Change in Happiness Inducing Behavior (HIB) 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). | 38-items assessing how often repondents have completed happiness inducing behaviors. Adapted scale and 7 response options range from Not at all to Multiple Times a Day |
| Change in Situational Motivation Scale (SIMS) | Post-intervention (Week 6), 1 month followup (Week 10), and 3 month followup (Week 18) only | 16-items assessing what motivates a respondent to use the MARIGOLD skills with 7 response options ranging from 1 Not at all to 7 Exactly |
| Technology Survey | Administered only at baseline (Week 1) and post-intervention (Week 6). | 6-items administered at baseline to assess level of technology use, modes of use, and frequency of use. 1-item technology question at post-intervention asking which device participants used the most for MARIGOLD. |
| Change in Pain | 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). | Single-Item pain measure assessed at each timepoint to measure change in pain level. Asks about the average level of pain over the past week on a scale of 0 to 10, with 0 being No pain and 10 being Pain as bad as you can imagine. |
| Change in Importance of Happiness (1-item measure) | 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). | 1 item measure on a 9-point scale ranging from 1 not very important to 9 very important |
| Change in Burnout 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). | rating health and sleep quality on a 9-point scale from 1 poor to 9 excellent |
| Change in Personality 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). | self-rated personality for dependability/discipline and disorganization/carelessness on a 9-point scale from 1 strongly disagree to 9 strongly agree. |
| Change in Life Satisfaction 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). | ratings of life, job, relationship on a 9-point scale, from 1 not satisfied to 9 satisfied |
Countries
United States
Outcome results
None listed