Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Psychological Distress Clinical Trial

Official title:

Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112225
• Other study ID #: 16
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: August 2020
• Source: Happify Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Loneliness
• Psychological Distress

Intervention

Behavioral:
• Happify
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Locations

Country	Name	City	State
United States	Happify (an online platform -- study is entirely online)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Happify Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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