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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04861844
• Other study ID #: STU00214284
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 22, 2023

Study information

• Verified date: April 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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:

1. 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).

2. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.

2. English-speaking; and

3. Able to verbally consent

Exclusion Criteria:

patients with dementia or otherwise not meeting inclusion criteria

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Behavioral:
• mindfulness training
phone based mindfulness training on 4 consecutive days
• active listening
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)

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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