Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Tracking Mood and Language Change Across a Phone-based Mindfulness Intervention

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: mindfulness training
* Behavioral: active listening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training<br> | Behavioral: mindfulness training<br>* phone based mindfulness training on 4 consecutive days<br>|
| Active Comparator: Active listening<br> | Behavioral: active listening<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 1 month |