Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Conditions
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Psychological Distress, Loneliness

Intervention / Treatment
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* Behavioral: Happify


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive affect condition<br>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. | Behavioral: Happify<br>* An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.<br>|
| Sham Comparator: Psychoeducation condition<br>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. | Behavioral: Happify<br>* An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From start of 8-week intervention (baseline) to immediately post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) | A 9-item measure of depressive symptoms | 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 | 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 | 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. | From start of 8-week intervention (baseline) to immediately post-intervention |