NCT04629755

Brief Summary

The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,765

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 9, 2020

Last Update Submit

November 17, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in depressed mood

    Depressed mood was measured using the first two symptom items of the Patient Health Questionnaire-2, "I felt down, depressed, or hopeless today" and "I had little interest or pleasure in doing things today"; both were rated with a slider from 0 (None of the time) to 10 (All of the time) with anchors "Some of the time" and "Most of the time" spaced evenly between.

    Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate

  • Change in loneliness

    Loneliness was measured using two items adapted from the UCLA Loneliness Scale, "I felt lonely today" and "I felt left out today" using a slider from 0 (Not at all) to 10 (Extremely).

    Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate

  • Change in relationship quality

    Relationship quality was measured using two items, "I felt closer and more connected to important people in my life today" with a slider including 0 (Not at all), 5 (A moderate amount) and 10 (Very much so) and "I felt satisfied with my relationships today" with a slider from 0 (Not at all) to 10 (Extremely).

    Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention was delivered via a series of daily text messages to mobile phones. Participants first were delivered an introductory text message at 6:00 pm on Day 7 of the study. This message alerted the participants to expect their first suggestion via text message at 8:00 am the following morning. For the next 14 days (Days 8 - 22), participants received one of 14 suggestions in random order. The specific daily suggestions varied in length and complexity: The simplest ones included text messages and a brief audiofile delivered via text; the more complex suggestions included text messages and a link to a web-page, which included text or embedded audiofiles describing why a suggestion was being made, how to engage in the suggested practice, and audiotaped exchanges between members of the production team describing what it was like to try the practices themselves. Some suggestions were supplemented with additional reminder and check-in text messages at noon and 4:00 pm.

Behavioral: Intervention

Control

NO INTERVENTION

Assessment only.

Interventions

InterventionBEHAVIORAL

The intervention was delivered via daily text messages to mobile phones during two weeks in the midst of the Covid-19 pandemic. Each message provided a link to a brief suggestion for an action or actions to take each day to improve relational closeness and well-being. Critical to the rationale for this intervention was the position that relationship science has developed key insights into what works and does not work to build and maintain closeness. These insights could be translated into brief and effective suggestions that individuals could implement daily, thereby quickly improving relational well-being and decreasing depression and loneliness at a critical time.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+
  • Resides in United States
  • Possesses smartphone
  • Willing to share phone number and email to researchers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

DepressionCOVID-19

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jonathan W Kanter, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

April 4, 2020

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations