Back to resultsTracking Mood and Language Change Across a Phone-based Mindfulness Intervention
Primary Purpose
Depression, Anxiety
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness training
active listening
Sponsored by
About this trial
This is an interventional supportive care trial for Depression, Anxiety
Eligibility Criteria
Inclusion Criteria:
- Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
- English-speaking; and
- Able to verbally consent
Exclusion Criteria:
patients with dementia or otherwise not meeting inclusion criteria
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness training
Active listening
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04861844
Brief Title
Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
Official Title
Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
difficulty recruiting patients, staffing
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 22, 2023 (Actual)
Study Completion Date
March 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness training
Arm Type
Experimental
Arm Title
Active listening
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
mindfulness training
Intervention Description
phone based mindfulness training on 4 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
active listening
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in mood assessed using the Profile of Mood States (POMS)
Description
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.
Time Frame
3 days
Title
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
Description
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.
Time Frame
3 days
Title
Change in mood assessed using the Profile of Mood States (POMS)
Description
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.
Time Frame
1 month
Title
Change in anxiety assessed using the State-Trait Anxiety Inventory (STAI).
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
English-speaking; and
Able to verbally consent
Exclusion Criteria:
patients with dementia or otherwise not meeting inclusion criteria
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention
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