ClinicalTrials.gg
CompletedNCT04567888Updated Aug 15, 2024Results posted

Testing a Digital Intervention for Adolescents

An interventional study of Happify Teens in Rumination and Stress, Psychological, sponsored by Happify Inc.. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Happify Inc. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
353
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Rumination
  • Stress, Psychological
03

In context

Rumination Syndrome

80 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.

This study's enrollment of 353 is above the median of 64 across 70 interventional studies indexed under Rumination Syndrome.

Browse Rumination Syndrome studies →

Lead sponsor

Happify Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Current or past user of any Happify platform
  • Non-US Resident
  • Perceived Stress Scale Score \< 10
  • Ruminative Responses Scale Score \< 14
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
353 participants (actual)

Study arms

  • Active comparator
    Happify Teens

    Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser

    Behavioral: Happify Teens

  • No intervention
    Waitlist Control

    Waitlist Control Condition

Interventions

  • BehavioralHappify Teens

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

06

What researchers measure

Primary outcomes

  1. 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). Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes

  1. Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]

    A 5-item measure of rumination (brooding) assessing how often participants engage with each of the 5 behaviors on a scale from almost never (1) to almost always (4). Ratings are summed so that total scores can range from 5 to 20, with higher scores indicating more brooding in the past month.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

07

Results

Posted Aug 15, 2024

Participant flow

Participant flow — Overall Study
MilestoneHappify TeensWaitlist Control
Started178175
Completed132171
Not completed464
Withdrew: Did not create happify for teens account220
Withdrew: Did not complete any happify for teens activities220
Withdrew: Reported unusual birth year23
Withdrew: Duplicate responses01

Outcome measures

PrimaryChange 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). Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.

Time frame:
Baseline, 4 weeks, 8 weeks, 12 weeks
Reported as:
Mean · score on a scale
Change in Perceived Stress [Perceived Stress Scale (PSS)]
score on a scaleHappify TeensWaitlist Control
Baseline26.33 ± 4.4325.26 ± 4.97
4 weeks22.01 ± 6.1024.67 ± 5.36
8 weeks21.95 ± 6.2024.61 ± 6.10
12 weeks20.96 ± 6.5724.44 ± 6.27
Statistical analysis
  • Happify Teens vs Waitlist Control · Repeated-measures Multilevel Models · p = <.001 (Threshold for statistical significance set to .050.) · Slope: -1.41 · 95% CI -1.88 to -0.95
SecondaryChange in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]

A 5-item measure of rumination (brooding) assessing how often participants engage with each of the 5 behaviors on a scale from almost never (1) to almost always (4). Ratings are summed so that total scores can range from 5 to 20, with higher scores indicating more brooding in the past month.

Time frame:
Baseline, 4 weeks, 8 weeks, 12 weeks
Reported as:
Mean · score on a scale
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
score on a scaleHappify TeensWaitlist Control
Baseline14.29 ± 2.3614.29 ± 2.56
4 weeks12.53 ± 3.2413.89 ± 3.01
8 weeks11.94 ± 2.8913.20 ± 2.85
12 weeks11.68 ± 3.1813.46 ± 3.03
Statistical analysis
  • Happify Teens vs Waitlist Control · Repeated-measures Multilevel Models · p = < .001 (Threshold for statistical significance was set to .050.) · Slope: -0.54 · 95% CI -0.78 to -0.30

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Happify Teens———
Waitlist Control———

Baseline characteristics

Age, Customized
Age, Customized(Participants)Happify TeensWaitlist ControlTotal
13 years192443
14 years444286
15 years303161
16 years364379
17 years473279
Missing or Unusual Birth Year235
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Happify TeensWaitlist ControlTotal
Female122110232
Male425092
Non-Binary/Other141428
Missing011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Happify TeensWaitlist ControlTotal
Hispanic or Latino192241
Not Hispanic or Latino159153312
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Happify TeensWaitlist ControlTotal
American Indian or Alaska Native314
Asian325
Native Hawaiian or Other Pacific Islander000
Black or African American91120
White140138278
More than one race171532
Unknown or Not Reported6814
Region of Enrollment
Region of Enrollment(participants)Happify TeensWaitlist ControlTotal
United States178175353
Perceived Stress Scale
Perceived Stress Scale(score on a scale)Happify TeensWaitlist ControlTotal
Mean26.06 ± 4.4125.29 ± 5.0425.68 ± 4.74
Ruminative Responses Scale - Brooding Subscale
Ruminative Responses Scale - Brooding Subscale(score on a scale)Happify TeensWaitlist ControlTotal
Mean14.18 ± 2.3214.29 ± 2.5514.23 ± 2.44
08

Study locations

1 site
  • Happify (an online platform -- study is entirely online)
    New York, New York 10012, United States
09

References and documents

Publications

  • Boucher EM, Ward H, Miles CJ, Henry RD, Stoeckl SE. Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 29;26:e54282. doi: 10.2196/54282. PubMed 38551617 ↗
  • Boucher EM, Ward HE, Stafford JL, Parks AC. Effects of a Digital Mental Health Program on Perceived Stress in Adolescents Aged 13-17 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 19;10(4):e25545. doi: 10.2196/25545. PubMed 33871377 ↗

Study documents

  • Study protocol · Nov 19, 2021
  • Statistical analysis plan · Sep 14, 2022

Documents are hosted by the registry — open the source record to download them.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Mar 2022, 9 months.

Results were first posted in Aug 2024, 2 years 5 months after primary completion.

Of 52 interventional studies with no phase under Rumination Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2020
First posted
Sep 29, 2020
StartActual
Jun 3, 2021
Primary completionActual
Mar 13, 2022
CompletionActual
Apr 11, 2022
Results first posted
Aug 15, 2024
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04567888
Lead sponsor
Happify Inc.
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Jun 3, 2021
Primary completion
Mar 13, 2022
Completion
Apr 11, 2022
Results posted
Aug 15, 2024
Last update
Aug 15, 2024

Study contacts

Eliane Boucher, PhD
principal investigator · Happify Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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