Rumination, Stress, Psychological
Conditions
Brief 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.
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.
Interventions
BEHAVIORALHappify Teens
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
Sponsors
Happify Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress [Perceived Stress Scale (PSS)] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Happify Teens Happify Teens is a digital well-being intervention that can be accessed via mobile application or web browser
Happify Teens: An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. | 178 |
| Waitlist Control Waitlist Control Condition | 175 |
| Total | 353 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did Not Complete Any Happify for Teens Activities | 22 | 0 |
| Overall Study | Did Not Create Happify for Teens Account | 22 | 0 |
| Overall Study | Duplicate Responses | 0 | 1 |
| Overall Study | Reported Unusual Birth Year | 2 | 3 |
Baseline characteristics
| Characteristic | Happify Teens | Waitlist Control | Total |
|---|---|---|---|
| Age, Customized 13 years | 19 Participants | 24 Participants | 43 Participants |
| Age, Customized 14 years | 44 Participants | 42 Participants | 86 Participants |
| Age, Customized 15 years | 30 Participants | 31 Participants | 61 Participants |
| Age, Customized 16 years | 36 Participants | 43 Participants | 79 Participants |
| Age, Customized 17 years | 47 Participants | 32 Participants | 79 Participants |
| Age, Customized Missing or Unusual Birth Year | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 22 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 153 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Perceived Stress Scale | 26.06 score on a scale STANDARD_DEVIATION 4.41 | 25.29 score on a scale STANDARD_DEVIATION 5.04 | 25.68 score on a scale STANDARD_DEVIATION 4.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 15 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) White | 140 Participants | 138 Participants | 278 Participants |
| Region of Enrollment United States | 178 participants | 175 participants | 353 participants |
| Ruminative Responses Scale - Brooding Subscale | 14.18 score on a scale STANDARD_DEVIATION 2.32 | 14.29 score on a scale STANDARD_DEVIATION 2.55 | 14.23 score on a scale STANDARD_DEVIATION 2.44 |
| Sex/Gender, Customized Female | 122 Participants | 110 Participants | 232 Participants |
| Sex/Gender, Customized Male | 42 Participants | 50 Participants | 92 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Non-Binary/Other | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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). 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Happify Teens | Change in Perceived Stress [Perceived Stress Scale (PSS)] | Baseline | 26.33 score on a scale | Standard Deviation 4.43 |
| Happify Teens | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 4 weeks | 22.01 score on a scale | Standard Deviation 6.1 |
| Happify Teens | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 8 weeks | 21.95 score on a scale | Standard Deviation 6.2 |
| Happify Teens | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 12 weeks | 20.96 score on a scale | Standard Deviation 6.57 |
| Waitlist Control | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 12 weeks | 24.44 score on a scale | Standard Deviation 6.27 |
| Waitlist Control | Change in Perceived Stress [Perceived Stress Scale (PSS)] | Baseline | 25.26 score on a scale | Standard Deviation 4.97 |
| Waitlist Control | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 8 weeks | 24.61 score on a scale | Standard Deviation 6.1 |
| Waitlist Control | Change in Perceived Stress [Perceived Stress Scale (PSS)] | 4 weeks | 24.67 score on a scale | Standard Deviation 5.36 |
p-value: <0.00195% CI: [-1.88, -0.95]Repeated-measures Multilevel Models
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Happify Teens | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | Baseline | 14.29 score on a scale | Standard Deviation 2.36 |
| Happify Teens | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 4 weeks | 12.53 score on a scale | Standard Deviation 3.24 |
| Happify Teens | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 8 weeks | 11.94 score on a scale | Standard Deviation 2.89 |
| Happify Teens | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 12 weeks | 11.68 score on a scale | Standard Deviation 3.18 |
| Waitlist Control | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 12 weeks | 13.46 score on a scale | Standard Deviation 3.03 |
| Waitlist Control | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | Baseline | 14.29 score on a scale | Standard Deviation 2.56 |
| Waitlist Control | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 8 weeks | 13.20 score on a scale | Standard Deviation 2.85 |
| Waitlist Control | Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale] | 4 weeks | 13.89 score on a scale | Standard Deviation 3.01 |
p-value: <0.00195% CI: [-0.78, -0.3]Repeated-measures Multilevel Models