An Online Trial of Five Well-being Programs

NCT03233022 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief Summary

Participants complete an 8-week program and complete assessment measures to track their outcomes over time.

Conditions

Well-being

Outcome Measures

Primary Outcomes (2)

• Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9)

  9-item measure of depressive symptoms

  Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up

• Anxiety Symptoms (Generalized Anxiety Disorder 7-item; GAD-7)

  7-item measure of anxiety symptoms

  Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up

Secondary Outcomes (1)

• Resilience composite

  Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up

Study Arms (5)

Unchanged Happify

ACTIVE COMPARATOR

Participants use Happify as it is currently available to consumers on the main site, including all engagement elements. Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period.

Behavioral: Happify

Negatively-focused tracks

ACTIVE COMPARATOR

Participants use two pre-selected Happify tracks that focus on remediating negatives (e.g. "conquering negative thoughts" and "managing stress"). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Positively-focused tracks

ACTIVE COMPARATOR

Participants use two pre-selected Happify tracks that focus on improving positives (e.g. building well-being, using one's strengths). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Placebo condition

PLACEBO COMPARATOR

Participants complete a Happify program that is designed to engage with specific activities, but that does not aim to promote positive emotion or reduce negative emotion. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Distraction condition

SHAM COMPARATOR

Participants complete a series of quizzes and polls on Happify designed to engage them in thinking about well-being topics, but without giving any specific instructions for how to promote well-being. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Interventions

Happify BEHAVIORAL

An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Distraction condition; Negatively-focused tracks; Placebo condition; Positively-focused tracks; Unchanged Happify

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No prior experience on the Happify platform (new user registration)

You may not qualify if:

• None

Sponsors & Collaborators

• Happify Inc.: lead

Study Sites (1)

Happify (an online platform -- study is entirely online)

New York, New York, 10012, United States

Location

Related Publications (1)

• Carpenter J, Crutchley P, Zilca RD, Schwartz HA, Smith LK, Cobb AM, Parks AC. Seeing the "Big" Picture: Big Data Methods for Exploring Relationships Between Usage, Language, and Outcome in Internet Intervention Data. J Med Internet Res. 2016 Aug 31;18(8):e241. doi: 10.2196/jmir.5725.

  PMID: 27580524 BACKGROUND

Related Links

• Site where study is taking place.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2017-08

Locations

US (1)