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

NCT ID: NCT04861844

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-03-22

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:

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness training

Group Type: EXPERIMENTAL

mindfulness training

Intervention Type: BEHAVIORAL

phone based mindfulness training on 4 consecutive days

Active listening

Group Type: ACTIVE_COMPARATOR

active listening

Intervention Type: BEHAVIORAL

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)

Interventions

mindfulness training

phone based mindfulness training on 4 consecutive days

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Sara Bradley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00214284

Identifier Type: -

Identifier Source: org_study_id