Depression, AnxietyNCT04861844
Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
A study testing mindfulness training and active listening in people with Depression, Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to administer a brief, phone(voice)-based training program in mindfulness (or control task of active listening to narrated articles) to older adults who receive primary care services at NM. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- mindfulness training and active listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 22 Mar 2023
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
- English-speaking; and
- Able to verbally consent
Who cannot join
- patients with dementia or otherwise not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
The objective of this study is to administer a brief, phone(voice)-based training program in mindfulness (or control task of active listening to narrated articles) to older adults who receive primary care services at NM. Older adults represent a population that is at risk for depression and anxiety, especially during the current COVID-19 pandemic and the social isolation it entails. Many older adults also possess relatively low access to application-based mindfulness training opportunities. The monitoring aims are:
- To determine whether the experimental intervention (mindfulness training) performs better than a control task (active listening) in improving mood assessed using the Profile of Mood States (POMS) and/or anxiety assessed using the State-Trait Anxiety Inventory (STAI).
- To determine whether the experimental and/or control intervention is associated with quantified changes in language use (e.g., frequency of negative word use), which may or may not also be associated with changes in mood and anxiety.
- Conditions
- Depression, Anxiety
- Being tested
- mindfulness training, active listening
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness trainingBehavioural
phone based mindfulness training on 4 consecutive days
active listeningBehavioural
The active listening intervention script asks the participant to attend by relaxing their body and visualizing themself in various exotic locations and narratives described in the script; it also asks the participant to rate their attention level of various points. The active listening scripts were compiled from National Geographic article excerpts (taken from the public domain)
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | Not described Receives: Behavioral: mindfulness training |
| Active listening | Active comparator | Not described Receives: Behavioral: active listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mood assessed using the Profile of Mood States (POMS)
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 65-item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "very strong". Higher score indicates worse mood.
Measured: 3 days
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
The State-Trait Anxiety Inventory (STAI) is psychological inventory consisting of 40 questions rated on a 4-point Likert scale. Higher score correlates with higher levels of anxiety.
Measured: 3 days
Change in mood assessed using the Profile of Mood States (POMS)
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 65-item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "very strong". Higher score indicates worse mood.
Measured: 1 month
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
The State-Trait Anxiety Inventory (STAI) is psychological inventory consisting of 40 questions rated on a 4-point Likert scale. Higher score correlates with higher levels of anxiety.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Apr 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Why it stopped: difficulty recruiting patients, staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Bradley, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861844
- Sponsor's protocol ID
- STU00214284
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2021
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
- ClinicalTrials.gov ID
- NCT04861844
- Acronym / sponsor ID
- STU00214284
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty recruiting patients, staffing
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 27 Apr 2021 (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 objective of this study is to administer a brief, phone(voice)-based training program in mindfulness (or control task of active listening to narrated articles) to older adults who receive primary care services at NM. Older adults represent a population that is at risk for depression and anxiety, especially during the current COVID-19 pandemic and the social isolation it entails. Many older adults also possess relatively low access to application-based mindfulness training opportunities. The monitoring aims are:
- To determine whether the experimental intervention (mindfulness training) performs better than a control task (active listening) in improving mood assessed using the Profile of Mood States (POMS) and/or anxiety assessed using the State-Trait Anxiety Inventory (STAI).
- To determine whether the experimental and/or control intervention is associated with quantified changes in language use (e.g., frequency of negative word use), which may or may not also be associated with changes in mood and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: mindfulness training |
| Active listening | Active comparator | Behavioral: active listening |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
- English-speaking; and
- Able to verbally consent
Key exclusion criteria (1 listed)
- patients with dementia or otherwise not meeting inclusion criteria
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 |
|---|---|---|
| mindfulness trainingphone based mindfulness training on 4 consecutive days | Behavioural | Mindfulness training |
| active listeningThe active listening intervention script asks the participant to attend by relaxing their body and visualizing themself in various exotic locations and narratives described in the script; it also asks the participant to rate their attention level of various points. The active listening scripts were compiled from National Geographic article excerpts (taken from the public domain) | Behavioural | Active listening |
Primary outcome
Change in mood assessed using the Profile of Mood States (POMS)
Time frame: 3 days
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 65-item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "very strong". Higher score indicates worse mood.
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
Time frame: 3 days
The State-Trait Anxiety Inventory (STAI) is psychological inventory consisting of 40 questions rated on a 4-point Likert scale. Higher score correlates with higher levels of anxiety.
Change in mood assessed using the Profile of Mood States (POMS)
Time frame: 1 month
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 65-item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "very strong". Higher score indicates worse mood.
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
Time frame: 1 month
The State-Trait Anxiety Inventory (STAI) is psychological inventory consisting of 40 questions rated on a 4-point Likert scale. Higher score correlates with higher levels of anxiety.
Results and safety
The study was stopped early (reason given: difficulty recruiting patients, staffing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 mindfulness training and active listening in people with Depression, Anxiety, run by Northwestern University 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 3 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: stopped early, as of the sponsor's last update on 12 Apr 2023. 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 was stopped early (reason given: difficulty recruiting patients, staffing). Results are not available in the source record.
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 mood assessed using the Profile of Mood States (POMS) (time frame: 3 days). The study lists 4 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 12 Apr 2023.