Psychological DistressNCT04112225
Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
A study testing Happify in people with Psychological Distress and Loneliness, run by Happify Inc. at 1 site in United States.
Trial summary
This study will use a longitudinal randomized experimental design. Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires at baseline and immediately post 8-week intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Distress, Loneliness
- What is being tested?
- Happify
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No prior experience on the Happify platform (new user registration)
- Located in the United States
- Self reported loneliness/desire to be more connected to others
Who cannot join
- Participants who are under the age of 18, reside outside of the United States, have previously registered for Happify, or did not self report loneliness/desire to be more connected with others
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
This study will use a longitudinal randomized experimental design. Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires at baseline and immediately post 8-week intervention.
Read the detailed description
Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group, with each intervention lasting 8-weeks. Participants in the positive affect skills intervention will have full access to the unchanged Happify platform.
The psychoeducation control group participants will use a version of the Happify platform that encourages thinking about well-being through quizzes and polls without providing any instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete questionnaires before and after the 8-week program, at which point study participation will end.
- Conditions
- Psychological Distress, Loneliness
- Being tested
- Happify
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HappifyBehavioural
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Positive affect condition | Active comparator | Participants use Happify as it is currently available to consumers on the main site, including all engagement elements. Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period. Receives: Behavioral: Happify |
| Psychoeducation condition | Sham comparator | Participants complete a series of quizzes and polls on Happify designed to engage them in thinking about well-being topics, but without giving any specific instructions for how to promote well-being. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period. Receives: Behavioral: Happify |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980)
A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Measured: From start of 8-week intervention (baseline) to immediately post-intervention
Secondary outcomes (4)
Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
A 9-item measure of depressive symptoms
Measured: From start of 8-week intervention (baseline) to immediately post-intervention
Generalized Anxiety Disorder Screener (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
A 7-item measure of anxiety symptoms
Measured: From start of 8-week intervention (baseline) to immediately post-intervention
Perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983)
10-item measure of perceived stress
Measured: From start of 8-week intervention (baseline) to immediately post-intervention
Resilience(composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985])
Composite score made of perceived stress, positive emotionality, and optimism. Perceived stress was measured using the Perceived Stress Scale (PSS; Cohen, Kamarck, \& Mermelstein, 1983), a 10-item questionnaire that asks users to rate on a scale of 0 (never) to 4 (very often) how frequently they experience various symptoms of feeling stress. Positive emotionality was measured using the emotion subscale of the Happify Scale (HS-E; Carpenter, Crutchley, Zilca, Schwartz, Smith, Cobb, \& Parks, 2016), which is a 4-item scale asking participants to rate the extent to which, over the past week, they have experienced positive and negative emotions that are activated or de-activated. Optimism was measured using the Life Orientation Scale, Revised (LOT-R; Scheier \& Carver, 1985), a 6-item scale on which participants rate the extent to which they identify with optimistic or pessimistic beliefs.
Measured: From start of 8-week intervention (baseline) to immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Aug 2019
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happify Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acacia Parks, PhD, Principal investigator, Happify Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112225
- Sponsor's protocol ID
- 16
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
- ClinicalTrials.gov ID
- NCT04112225
- Acronym / sponsor ID
- 16
- Conditions
- Psychological Distress, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a longitudinal randomized experimental design. Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires at baseline and immediately post 8-week intervention.
Detailed description
Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group, with each intervention lasting 8-weeks. Participants in the positive affect skills intervention will have full access to the unchanged Happify platform.
The psychoeducation control group participants will use a version of the Happify platform that encourages thinking about well-being through quizzes and polls without providing any instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete questionnaires before and after the 8-week program, at which point study participation will end.
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 |
|---|---|---|
| Positive affect condition | Active comparator | Behavioral: HappifyParticipants use Happify as it is currently available to consumers on the main site, including all engagement elements. Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period. |
| Psychoeducation condition | Sham comparator | Behavioral: HappifyParticipants complete a series of quizzes and polls on Happify designed to engage them in thinking about well-being topics, but without giving any specific instructions for how to promote well-being. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No prior experience on the Happify platform (new user registration)
- Located in the United States
- Self reported loneliness/desire to be more connected to others
Key exclusion criteria (1 listed)
- Participants who are under the age of 18, reside outside of the United States, have previously registered for Happify, or did not self report loneliness/desire to be more connected with others
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 |
|---|---|---|
| HappifyAn online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. | Behavioural | Positive affect condition, Psychoeducation condition |
Primary outcome
Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980)
Time frame: From start of 8-week intervention (baseline) to immediately post-intervention
A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
4 secondary outcomes
Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: From start of 8-week intervention (baseline) to immediately post-intervention
Generalized Anxiety Disorder Screener (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
Time frame: From start of 8-week intervention (baseline) to immediately post-intervention
Perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983)
Time frame: From start of 8-week intervention (baseline) to immediately post-intervention
Resilience(composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985])
Time frame: From start of 8-week intervention (baseline) to immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Acacia Parks, 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 in people with Psychological Distress and Loneliness, 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 3 inclusion and 1 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 2 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980) (time frame: From start of 8-week intervention (baseline) to immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.