Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

NCT04112225 | Completed

• 1 other identifier: 16
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Loneliness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Depression Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

  From start of 8-week intervention (baseline) to immediately post-intervention

• Generalized Anxiety Disorder Screener (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

  From start of 8-week intervention (baseline) to immediately post-intervention

• Perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983)

  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])

  From start of 8-week intervention (baseline) to immediately post-intervention

Study Arms (2)

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.

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.

Behavioral: Happify

Interventions

Happify BEHAVIORAL

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

Positive affect condition; Psychoeducation condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Happify Inc.: lead

Study Sites (1)

Happify (an online platform -- study is entirely online)

New York, New York, 10012, United States

Location

Study Officials

• Acacia Parks, PhD

  Happify Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: August 1, 2019
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)