NCT04602832

Brief Summary

This study is a randomized controlled trial of an online, evidenced-based intervention (the ENHANCE program) that was modified to address the health and well-being challenges of COVID-19. Eligible participants will be randomized into the ENHANCE or Wait-List Control group over a 12-week period. ENHANCE participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. Participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 23, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

Health and Well-BeingPositive Psychology InterventionOnline Bibliotherapy

Outcome Measures

Primary Outcomes (7)

  • Beck Depression Inventory - II (BDI-II)

    Change from baseline mood

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Satisfaction With Life Scale (SWLS)

    Change from baseline satisfaction with life

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Generalized Anxiety Disorder - 7 (GAD-7)

    Change from baseline anxiety

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Patient Health Questionnaire (PHQ-9)

    Change from baseline mood

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Perceived Stress Scale (PSS)

    Change from baseline stress

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Positive and Negative Affect Scale (PANAS)

    Change from baseline affect

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Health Anxiety Inventory Short-Form (HAI-SF)

    Change from baseline anxiety

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

Secondary Outcomes (9)

  • World Health Organization Quality of Life (WHOQOL - BREF)

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Meaning In Life Questionnaire (MLQ)

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Sleep Disorder Questionnaire (SDQ)

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • Measure of Attachment Qualities (MAQ)

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)

    Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)

  • +4 more secondary outcomes

Study Arms (2)

ENHANCE Treatment Group

EXPERIMENTAL

The ENHANCE program was tailored to address the current health and well-being challenges faced by individuals living in the COVID-19 pandemic. The contents of each week will focus on a new evidenced-based principle that has been shown in research to decrease negative thinking and emotions, as well as increase positive thinking, emotions, and overall physical and mental health and well-being. Each week participants will focus on the skills and methods of implementing happiness and well-being into their daily routine.

Other: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19

Wait-List Control Group

NO INTERVENTION

Over the course of the study, participants will be asked to refrain from accessing the ENHANCE program materials to ensure the integrity of the research design. At the end of the study duration, participants will receive the full ENHANCE program.

Interventions

ENHANCE is a 12-session program designed to help improve subjective well-being, especially through the challenges of a pandemic. The ENHANCE program introduces and teaches people about the evidence-based principles and skills that have been shown across decades of research to improve overall health and well-being.

ENHANCE Treatment Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are fluent in English and are 19 years or older.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lesley Lutes, R.Psych.

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 26, 2020

Study Start

October 14, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-10

Locations