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Trial record 71 of 2657 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)

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ClinicalTrials.gov Identifier: NCT02861755
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : December 14, 2017
Sponsor:
Collaborators:
University of California, San Francisco
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Depression Psychological Stress Affect Behavioral: Positive Affect Skills Training Behavioral: 5-week Emotion Reporting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 677 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
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.
Behavioral: Positive Affect Skills Training
Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.

Experimental: Arm 2
Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course.
Behavioral: 5-week Emotion Reporting



Primary Outcome Measures :
  1. Change in Retention Over Time (average of 4.5 months through study completion) [ Time Frame: 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.

  2. Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion) [ Time Frame: 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"

  3. Change in Depression symptoms (CES-D questionnaire) Over Time [ Time Frame: 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 :
  1. Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time [ Time Frame: 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"

  2. Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week") [ Time Frame: 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?"

  3. Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 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"

  4. Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale) [ Time Frame: 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"

  5. Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months) [ Time Frame: 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"

  6. Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study) [ Time Frame: 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"

  7. Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study) [ Time Frame: 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"

  8. Change in Meaning and Purpose Scale over time (4.5 months of participation in the study) [ Time Frame: 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"

  9. Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank [ Time Frame: 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"

  10. Change in General Behavior Inventory (GBI) Scale [ Time Frame: 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?"

  11. Change in Behavioral Activation for Depression Scale (BADS) [ Time Frame: 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."

  12. Change in Stress Management Self-Efficacy (SMSE) [ Time Frame: 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.

  13. Expectancy Credibility Scale [ Time Frame: 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?"

  14. Change in Self Compassion Scale (SCS) Short-Form [ Time Frame: 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."

  15. Change in Self-Stigma Depression Scale (SSDS) [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Life Satisfaction Scale [ Time Frame: 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"

  2. Change in Burnout Scale [ Time Frame: 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"

  3. Change in Importance of Happiness (1-item measure) [ Time Frame: 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"

  4. Change in Personality Scale [ Time Frame: 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."

  5. Change in Daily Inventory of Stressful Events (DISE) Self-Assessment over 5 weeks (daily) [ Time Frame: 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"

  6. Change in Differential Emotions Scale (DES) over 5 weeks (daily) [ Time Frame: 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?"

  7. Change in self-reported mental health status [ Time Frame: 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."

  8. Change in Happiness Inducing Behavior (HIB) Scale [ Time Frame: 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"

  9. Change in Situational Motivation Scale (SIMS) [ Time Frame: 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"

  10. Technology Survey [ Time Frame: 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.

  11. Change in Pain [ Time Frame: 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."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861755


Locations
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United States, Illinois
Northwestern University, Feinberg School of Medicine, MSS Dept
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of California, San Francisco
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Judith T Moskowitz, PhD, MPH Northwestern University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT02861755     History of Changes
Other Study ID Numbers: STU00092507
R34MH101265-02 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Northwestern University:
Depression
Depressive Disorder
Psychological Stress
Behavioral Symptoms
Mental Disorders
Mood Disorders

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Stress, Psychological
Behavioral Symptoms
Mood Disorders
Mental Disorders