RuminationNCT04567888
Testing a Digital Intervention for Adolescents
A study testing Happify Teens in people with Rumination and Stress, Psychological, run by Happify Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Rumination, Stress, Psychological
- What is being tested?
- Happify Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Current or past user of any Happify platform
- Non-US Resident
- Perceived Stress Scale Score < 10
- Ruminative Responses Scale Score < 14
Trial locations and contacts
1 site in 1 country.
United States1 site
Happify (an online platform -- study is entirely online)
New York, New York, 10012
About this study
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.
- Conditions
- Rumination, Stress, Psychological
- Being tested
- Happify Teens
- Medical subject headings
- Rumination Syndrome, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happify TeensBehavioural
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Happify Teens | Active comparator | Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser Receives: Behavioral: Happify Teens |
| Waitlist Control | No intervention | Waitlist Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start3 Jun 2021
- Primary completion13 Mar 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happify Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliane Boucher, PhD, Principal investigator, Happify Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567888
- Sponsor's protocol ID
- HLS-20
- Status last verified
- Mar 2024
- First submitted
- 23 Sep 2020
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 38551617Boucher 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 at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Digital Intervention for Adolescents
- ClinicalTrials.gov ID
- NCT04567888
- Acronym / sponsor ID
- HLS-20
- Conditions
- Rumination, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Happify Teens | Active comparator | Behavioral: Happify TeensHappify Teens is a digital well-being intervention that can be accessed via mobile application or web browser |
| Waitlist Control | No intervention | –Waitlist Control Condition |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 13-17 years of age
- US resident
- Perceived Stress Scale Score ≥ 10
- Ruminative Responses Scale Score ≥ 14
- Ability and willingness to complete study activities
Key exclusion criteria (4 listed)
- Current or past user of any Happify platform
- Non-US Resident
- Perceived Stress Scale Score < 10
- Ruminative Responses Scale Score < 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happify TeensAn online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. | Behavioural | Happify Teens |
Primary outcome
Change in Perceived Stress [Perceived Stress Scale (PSS)]
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
1 secondary outcome
Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38551617Boucher 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.
- Derived from this study: PubMed 33871377Boucher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane Boucher, PhD principal investigator
Happify Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happify Teens in people with Rumination and Stress, Psychological, run by Happify Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress [Perceived Stress Scale (PSS)] (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04567888, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.