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NCT03233022 Clinical Trial

An Online Trial of Five Well-being Programs

Well-being Clinical Trial

Official title:
A Randomized Trial Examining the Impact of Five 8-week Online Well-being Programs on Mood and Well-being

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03233022
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date March 2018

Study information
Verified date August 2017
Source Happify Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Participants will be randomly assigned between five different well-being programs, each 8-weeks long and taking place on a simplified research version of the Happify platform. They will be asked to complete questionnaires before and after the 8-week program, as well as 1-month, 3-month, and 6-month follow-up questionnaires after the program is complete, at which point study participation will end.

Recruitment information / eligibility
Status Completed
Enrollment 14000
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Happify (an online platform -- study is entirely online) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Happify Inc.

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: J Med Internet Res. 2017 Dec 19;19(12 ):e347. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Resilience composite Composite score made of perceived stress, positive emotionality, and optimism Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
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