NCT02861755

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

June 13, 2016

Last Update Submit

October 26, 2023

Conditions

DepressionPsychological StressAffect

Keywords

DepressionDepressive DisorderPsychological StressBehavioral SymptomsMental DisordersMood Disorders

Outcome Measures

Primary Outcomes (3)

  • Change in Retention Over Time (average of 4.5 months through study completion)

    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.

    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.

  • Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)

    8-items; responses range from 0 "not at all" to 3 "almost every day"

    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).

  • Change in Depression symptoms (CES-D questionnaire) Over Time

    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)"

    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).

Secondary Outcomes (15)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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 more secondary outcomes

Other Outcomes (11)

  • 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).

  • 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).

  • 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).

  • +8 more other outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course.

Behavioral: 5-week Emotion Reporting

Interventions

Positive Affect Skills TrainingBEHAVIORAL

Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.

Arm 1
5-week Emotion ReportingBEHAVIORAL
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, Feinberg School of Medicine, MSS Dept

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.

    PMID: 22021272BACKGROUND

  • Moskowitz JT, Jackson K, Freedman ME, Grote VE, Kwok I, Schuette SA, Cheung EO, Addington EL. Positive Psychological Intervention Effects on Depression: Positive Emotion Does Not Mediate Intervention Impact in a Sample with Elevated Depressive Symptoms. Affect Sci. 2022 Oct 6;4(1):163-173. doi: 10.1007/s42761-022-00140-7. eCollection 2023 Mar.

    PMID: 37070017DERIVED

  • Moskowitz JT, Addington EL, Shiu E, Bassett SM, Schuette S, Kwok I, Freedman ME, Leykin Y, Saslow LR, Cohn MA, Cheung EO. Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e25922. doi: 10.2196/25922.

    PMID: 34550076DERIVED

  • Cheung EO, Addington EL, Bassett SM, Schuette SA, Shiu EW, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD. JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.

    PMID: 29871853DERIVED

MeSH Terms

Conditions

DepressionStress, PsychologicalDepressive DisorderBehavioral SymptomsMental DisordersMood Disorders

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Judith T Moskowitz, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2016

First Posted

August 10, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

US(1)