Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Not Applicable

Completed

• Conditions: Loneliness; Psychological Distress

• Registration Number: NCT04112225
• Lead Sponsor: Happify Inc.

Brief 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.

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 Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980)	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.

Secondary Outcome Measures

Name	Time	Method
Resilience(composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985])	From start of 8-week intervention (baseline) to immediately post-intervention	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.
Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	From start of 8-week intervention (baseline) to immediately post-intervention	A 9-item measure of depressive symptoms
Generalized Anxiety Disorder Screener (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)	From start of 8-week intervention (baseline) to immediately post-intervention	A 7-item measure of anxiety symptoms
Perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983)	From start of 8-week intervention (baseline) to immediately post-intervention	10-item measure of perceived stress

Trial Locations

Locations (1)

Happify (an online platform -- study is entirely online); 🇺🇸 New York, New York, United States