Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

Sponsor
Happify Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04112225
Collaborator
(none)
890
1
2
7.8
114.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Happify
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
890 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.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)
Primary Purpose:
Other
Official Title:
Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Positive affect condition

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

Sham Comparator: Psychoeducation condition

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Happify (an online platform -- study is entirely online) New York New York United States 10012

Sponsors and Collaborators

  • Happify Inc.

Investigators

  • Principal Investigator: Acacia Parks, PhD, Happify Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Happify Inc.
ClinicalTrials.gov Identifier:
NCT04112225
Other Study ID Numbers:
  • 16
First Posted:
Oct 2, 2019
Last Update Posted:
Sep 2, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 2, 2020