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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04567888
Other study ID # HLS-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2021
Est. completion date April 11, 2022

Study information

Verified date April 2023
Source Happify Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Teen participants (ages 13-17) will be randomly assigned to either an experimental (the Happify Teens digital platform), or a waitlist control group. The study includes an 8-week intervention period and a 1-month follow up period.


Description:

Teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to Happify Teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness. Participants assigned to the waitlist (control) condition will not have access to the Happify Teens platform for the full study period (12 weeks total). Participants in the waitlist control will receive access to Happify Teens after the full study period is complete (12 weeks). Perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1 month post intervention.


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date April 11, 2022
Est. primary completion date March 13, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - 13-17 years of age - US resident - Perceived Stress Scale Score = 10 - Ruminative Responses Scale Score = 14 - Ability and willingness to complete study activities - Willingness and access to using a digital intervention via mobile application or web browser Exclusion Criteria: - Current or past user of any Happify platform - Non-US Resident - Perceived Stress Scale Score < 10 - Ruminative Responses Scale Score < 14

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Happify Teens
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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Perceived Stress [Perceived Stress Scale (PSS)] 10-item measure of perceived stress scoring how often the participant felt stressed by each statement in the following month from never (0) to very often (4), with higher scores indicating higher levels of perceived stress. Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] A 5-item measure of rumination (brooding) scoring how often participants engage with each of the 5 behaviors on a scale from almost never (1) to almost always (4), with higher scores indicating more brooding in the past month. Baseline, 4 weeks, 8 weeks, 12 weeks
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