Online Positive Emotion Skills Intervention for Symptoms of Depression

NCT ID: NCT02861755

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

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) 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

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Conditions

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Depression Psychological Stress Affect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Positive Affect Skills Training

Intervention Type BEHAVIORAL

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

Arm 2

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

Group Type EXPERIMENTAL

5-week Emotion Reporting

Intervention Type BEHAVIORAL

Interventions

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Positive Affect Skills Training

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

Intervention Type BEHAVIORAL

5-week Emotion Reporting

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Judith Moskowitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith T Moskowitz, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University, Feinberg School of Medicine, MSS Dept

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22021272 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37070017 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34550076 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29871853 (View on PubMed)

Other Identifiers

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R34MH101265-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00092507

Identifier Type: -

Identifier Source: org_study_id

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