LonelinessNCT04164654
A Mobile App to Address Student Loneliness
A study testing Loneliness Intervention in people with Loneliness, run by University of Oregon at 1 site in United States.
Trial summary
The purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Loneliness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 6 May 2021
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Incoming college first years
- Live away from home without parents/guardians upon beginning college
- Read English
- Between 18 and 25 years of age
- Own a smartphone
Who cannot join
- Do not read English
- Under 18 years of age
- Over 25 years of age
- Do not own a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Mobile App to Address Student Loneliness Among College Students: A Randomized Controlled Trial
The purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline.
Read the detailed description
This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist" control strategy for the first 4 weeks of the study (considered to be the active study period).
Randomization will be to one of two conditions:
- Experimental group: Immediate access to the Nod app
- Waitlist control group: Participants will be granted access to the app four weeks after the experimental group
Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include measures of loneliness, and other mental health and institutional satisfaction measures listed in the secondary outcome measures section.
- Conditions
- Loneliness
- Being tested
- Loneliness Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loneliness InterventionBehavioural
Also called A mobile app called Nod
28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations)
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Immediate Access to the Nod app | Experimental | The experimental group will have immediate access to all content in the Nod app and will be free to engage with it as much or as little as they like for four weeks. They will retain access to the Nod app for an additional four weeks. Receives: Behavioral: Loneliness Intervention |
| Waitlist Control-Delayed Access to the Nod app | Other | The waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access. Receives: Behavioral: Loneliness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condition differences in self-reported loneliness
Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.
Measured: 2-weeks post baseline
Condition differences in self-reported loneliness
Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.
Measured: 4-weeks post baseline
Secondary outcomes (4)
Depressive symptoms
Total score on the Patient Health Questionnaire 9-item scale. Scores range from 0-27, higher scores indicate worse depression.
Measured: 2 and 4 weeks post baseline
Anxiety
Total score on the Generalized Anxiety Disorder 7-item scale. Scores range from 0-21, higher scores indicate worse anxiety.
Measured: 2 and 4 weeks post baseline
Social Anxiety
Total score on the Mini Social Phobia Inventory. Scores range from 0-12, higher scores indicate worse social anxiety.
Measured: 2 and 4 weeks post baseline
Self-reported intention to remain enrolled at the University of Oregon in the next academic year
Self-reported intention to remain enrolled at the University of Oregon in the next academic year
Measured: 2 and 4 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start9 Sep 2019
- Primary completion20 Oct 2020
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- HopeLab Foundation, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164654
- Sponsor's protocol ID
- 06072019.014
- Other IDs
- R34DA041637
- Status last verified
- Sep 2022
- First submitted
- 13 Nov 2019
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruehlman-Senecal E, Hook CJ, Pfeifer JH, FitzGerald C, Davis B, Delucchi KL, Haritatos J, Ramo DE. Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Oct 20;7(10):e21496. doi: 10.2196/21496.
PubMed 33079071
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Mobile App to Address Student Loneliness Among College Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04164654
- Acronym / sponsor ID
- 06072019.014
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- HopeLab Foundation, National Institute on Drug Abuse (NIDA)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 15 Nov 2019 (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 purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline.
Detailed description
This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist" control strategy for the first 4 weeks of the study (considered to be the active study period).
Randomization will be to one of two conditions:
- Experimental group: Immediate access to the Nod app
- Waitlist control group: Participants will be granted access to the app four weeks after the experimental group
Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include measures of loneliness, and other mental health and institutional satisfaction measures listed in the secondary outcome measures section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental-Immediate Access to the Nod app | Experimental | Behavioral: Loneliness InterventionThe experimental group will have immediate access to all content in the Nod app and will be free to engage with it as much or as little as they like for four weeks. They will retain access to the Nod app for an additional four weeks. |
| Waitlist Control-Delayed Access to the Nod app | Other | Behavioral: Loneliness InterventionThe waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Incoming college first years
- Live away from home without parents/guardians upon beginning college
- Read English
- Between 18 and 25 years of age
- Own a smartphone
Key exclusion criteria (4 listed)
- Do not read English
- Under 18 years of age
- Over 25 years of age
- Do not own a smartphone
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 |
|---|---|---|
| Loneliness InterventionAlso: A mobile app called Nod28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations) | Behavioural | Experimental-Immediate Access to the Nod app, Waitlist Control-Delayed Access to the Nod app |
Primary outcome
Condition differences in self-reported loneliness
Time frame: 2-weeks post baseline
Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.
Condition differences in self-reported loneliness
Time frame: 4-weeks post baseline
Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.
4 secondary outcomes
Depressive symptoms
Time frame: 2 and 4 weeks post baseline
Anxiety
Time frame: 2 and 4 weeks post baseline
Social Anxiety
Time frame: 2 and 4 weeks post baseline
Self-reported intention to remain enrolled at the University of Oregon in the next academic year
Time frame: 2 and 4 weeks post baseline
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 15 Sep 2022.
- Derived from this study: PubMed 33079071Bruehlman-Senecal E, Hook CJ, Pfeifer JH, FitzGerald C, Davis B, Delucchi KL, Haritatos J, Ramo DE. Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Oct 20;7(10):e21496. doi: 10.2196/21496.
- Individual participant dataSharing planned: No
Related trials for Loneliness
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loneliness Intervention in people with Loneliness, run by University of Oregon 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 5 inclusion and 4 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 15 Sep 2022. 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?
Condition differences in self-reported loneliness (time frame: 2-weeks post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164654, which also lists 1 linked publication.
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 15 Sep 2022.