NCT05433636

Brief Summary

This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare. A secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
305

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

June 21, 2022

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    75% of patients that begin an audio recording will listen to the full, 5-minute recording

    A single 5-minute period

Secondary Outcomes (3)

  • Change in Pain

    Immediately before to after 5-minute audio recording

  • Change in Anxiety

    Immediately before to after 5-minute audio recording

  • Change in Depression

    Immediately before to after 5-minute audio recording

Study Arms (5)

Body Scan Practice

EXPERIMENTAL
Behavioral: Body Scan

Mindful Breathing Practice

EXPERIMENTAL
Behavioral: Mindful Breathing

Mindfulness of Discomfort Practice

EXPERIMENTAL
Behavioral: Mindfulness of Discomfort

Mindful Savoring Practice

EXPERIMENTAL
Behavioral: Mindful Savoring

Integrative Health Recording

ACTIVE COMPARATOR
Behavioral: Integrative Health Recording

Interventions

Body ScanBEHAVIORAL

Patients will listen to a 5-minute, audio-recorded body scan practice.

Body Scan Practice

Patients will listen to a 5-minute, audio-recorded mindful breathing practice.

Mindful Breathing Practice

Patients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice.

Mindfulness of Discomfort Practice

Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

Mindful Savoring Practice

Patients will listen to a 5-minute, audio-recorded description of integrative health.

Integrative Health Recording

Eligibility Criteria

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

You may qualify if:

  • Seeking treatment at the Huntsman Cancer Institute's Wellness Center
  • Adults 18+
  • Facility with the English language that is adequate to complete study procedures

You may not qualify if:

  • Cognitive impairment preventing completion of study procedures
  • An unstable illness judged by medical staff to interfere with study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionPainNauseaFatigueNeoplasms

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

September 14, 2022

Primary Completion

September 14, 2024

Study Completion

December 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations