NCT04861844

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. 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 8, 2021

Last Update Submit

April 10, 2023

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Mindfulness training

EXPERIMENTAL
Behavioral: mindfulness training

Active listening

ACTIVE COMPARATOR
Behavioral: active listening

Interventions

mindfulness trainingBEHAVIORAL

phone based mindfulness training on 4 consecutive days

Mindfulness training
active listeningBEHAVIORAL

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)

Active listening

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients part of the Northwestern Medicine Geriatrics Practice, or Northwestern Feinberg School of Medicine ECMH program.
  • English-speaking; and
  • Able to verbally consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 27, 2021

Study Start

April 1, 2021

Primary Completion

March 22, 2023

Study Completion

March 22, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)