NCT05248711

Brief Summary

The purpose of this study is to test the feasibility (acceptability and demand) of the Daily Move in a diverse sample of US adults. Acceptability benchmarks: 214 participants recruited within three months (60% will identify as a racial/ethnic minority; 30% African American, 30% Hispanic); At least 70% of participants rate the intervention as satisfactory. Demand benchmarks: At least 70% of participants complete 75% of prescribed Daily Move sessions per week across the 8-weeks; Dropouts not to exceed \>30% of participants. Aim 2 - explore the pre-post trends in change of: Stress - Perceived Stress Scale (PSS), Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS), Mindfulness- Mindful Attention Awareness Scale (MAAS), and Mood- Profile of Mood States (POMS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

January 19, 2022

Last Update Submit

August 19, 2022

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Stress

    Stress will be measured using the Perceived Stress Scale (PSS).

    Changes in stress will be measured at baseline, week 2, week 4, week 6, and week 8 (post-intervention). The PSS includes 10 items with total scores ranging from 0-40.

Secondary Outcomes (4)

  • Anxiety

    Changes in anxiety will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing anxiety symptoms with a total score range of 0-21.

  • Depression

    Changes in depression will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing depressive symptoms with a total score range of 0-21.

  • Mindfulness

    Changes in mindfulness will be measured at baseline, week 4, and week 8 (post-intervention). The MAAS is a 15-item scale with total possible scores ranging from 15-90, with higher scores indicating greater mindfulness.

  • Mood

    Changes in mood will be measured at baseline, week 4, and week 8 (post-intervention). The POMS is a 65-item scale with six sub scales. Each item is scored on a 0-4 scale, yielding a total possible score range of -24 to 177.

Other Outcomes (1)

  • Study Satisfaction

    Study satisfaction will be measured at week 8 (post-intervention).

Study Arms (2)

Daily Move

EXPERIMENTAL

Participants (n=107) will be provided free access to and asked to register for the consumer-based mobile meditation app, Calm, on their phone. Participants will then receive an email containing one year of free access to Calm. Participants will be asked to use the Daily Move component on the Calm app for \~10 minutes per day for 8 weeks.

Behavioral: Calm Daily Move

Usual Care

NO INTERVENTION

Participants (n=107) will be asked to continue with usual care/routine and complete survey measures at each time point. Participants will be provided with access to the intervention after their study participation.

Interventions

Calm Daily MoveBEHAVIORAL

The Daily Move is a series of short, 5-min videos outlining mindful movement exercises. The Daily Move is part of the Calm app's library of content.

Daily Move

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Score of 6 or greater on the Perceived Stress Scale-4

You may not qualify if:

  • Subscribe to Calm or use Calm
  • Live outside of the United States of America
  • Unable to read or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calm, Inc.

San Francisco, California, 94105, United States

Location

Study Officials

  • Calm

    Calm.com, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 21, 2022

Study Start

January 6, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)