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Completed

NCT Number: NCT04112225

Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

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.

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Key information

Conditions

Psychological Distress Loneliness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10012, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Happify

Behavioral

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

Primary outcomes

  1. Loneliness (Revised UCLA Loneliness Scale; Russell, Peplau, & Cutrona, 1980)

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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])

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Happify Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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