DepressionNCT04629755
A Smartphone Intervention for Relational and Mental Well Being
A study testing Intervention in people with Depression and Loneliness, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Loneliness, Relation, Interpersonal
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,765 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2020to 3 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Resides in United States
- Possesses smartphone
- Willing to share phone number and email to researchers
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
We conducted a randomized intervention trial of a mobile-based intervention that offered participants daily suggestions for 14 days on how to improve relational and mental well-being during the COVID-19 pandemic. A sample of 1765 adults residing in the United States participated in the study and were assigned to control or intervention conditions. To measure outcomes, all participants received a daily text message to their smartphones every evening for 28 days linking to a survey on relational and mental well-being. Participants also received a survey link on Days 56 and 72. Intervention participants received additional text messages in the mornings of Days 7 - 22 presenting the intervention suggestions.
- Conditions
- Depression, Loneliness, Relation, Interpersonal, Covid19
- Being tested
- Intervention
- Medical subject headings
- Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
| Control | No intervention | Assessment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start4 Apr 2020
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Kanter, University of Washington
- Investigators
- Jonathan W Kanter, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629755
- Sponsor's protocol ID
- STUDY00009897
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Intervention for Relational and Mental Well Being
- ClinicalTrials.gov ID
- NCT04629755
- Acronym / sponsor ID
- STUDY00009897
- Conditions
- Depression, Loneliness, Relation, Interpersonal, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,765 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We conducted a randomized intervention trial of a mobile-based intervention that offered participants daily suggestions for 14 days on how to improve relational and mental well-being during the COVID-19 pandemic. A sample of 1765 adults residing in the United States participated in the study and were assigned to control or intervention conditions. To measure outcomes, all participants received a daily text message to their smartphones every evening for 28 days linking to a survey on relational and mental well-being. Participants also received a survey link on Days 56 and 72. Intervention participants received additional text messages in the mornings of Days 7 - 22 presenting the intervention suggestions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| Control | No intervention | –Assessment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Resides in United States
- Possesses smartphone
- Willing to share phone number and email to researchers
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Behavioural | Intervention |
Primary outcome
Change in depressed mood
Time frame: 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
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.
Change in loneliness
Time frame: 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
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).
Change in relationship quality
Time frame: 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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Kanter, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Depression and Loneliness, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressed mood (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.