Clinical trial NCT04112225: Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
Official title: Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Loneliness
Lead sponsor: Happify Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 890
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980)
timeFrame: From start of 8-week intervention (baseline) to immediately post-intervention
Secondary outcomes:
measure: Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
timeFrame: From start of 8-week intervention (baseline) to immediately post-intervention
measure: Generalized Anxiety Disorder Screener (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
timeFrame: From start of 8-week intervention (baseline) to immediately post-intervention
measure: Perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983)
timeFrame: From start of 8-week intervention (baseline) to immediately post-intervention
measure: Resilience(composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985])
timeFrame: From start of 8-week intervention (baseline) to immediately post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Happify (an online platform -- study is entirely online)
state: New York
Study officials:
affiliation: Happify Inc.
name: Acacia Parks, PhD
role: PRINCIPAL_INVESTIGATOR
References: