NCT06278649

Brief Summary

The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2024

Status
not yet 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

February 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 12, 2024

Last Update Submit

February 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Asthma

    Lung functioning as measured through spirometry data (Forced Vital Capacity)

    Taken during weekly meeting occuring for 3-5 weeks during pre-intervention period, 3-5 weeks during intervention period, 1 week during the post-intervention period

  • Asthma

    Lung functioning as measured through spirometry data (Forced Expiratory Volume 1)

    Taken during weekly meeting occuring for 3-5 weeks during pre-intervention period, 3-5 weeks during intervention period, 1 week during the post-intervention period

  • Anxiety

    Anxiety as measured by the State-Trait Anxiety Inventory; measures general levels of anxiety (trait) and current levels of anxiety (state) on a scale from 20 (minimum) to 80 (maximum) with higher scores corresponding to higher levels of anxiety (lower score = better outcome)

    Taken during weekly meeting occuring for 3-5 weeks during pre-intervention period, 3-5 weeks during intervention period, 1 week during the post-intervention period

Secondary Outcomes (1)

  • Quality of Life

    Taken during one pre-intervention meeting and one post-intervention

Study Arms (1)

Relaxation and Guided Imagery Intervention

EXPERIMENTAL

During the RGI sessions, the participant will be told to lie down on an exercise mat while a 15 minute relaxation and guided imagery audio recording is played. During the relaxation portion of the script, the participant will be instructed to let go of tension they might feel in individual parts of their body (starting with their feet and working their way up). The second portion is the guided imagery portion, which includes asking each participant to imagine themselves in a peaceful place. The participant will then be guided to imagine healing in the specific bronchial tubes and lungs, asking them to imagine themselves doing a favorite activity in which they have no trouble with their asthma, and asking them to visualize breathing in a colored air that would clear the airways and lungs.

Behavioral: Relaxation and Guided Imagery

Interventions

Listening to a 15 minute relaxing pre-recorded script while laying down on an exercise mat

Relaxation and Guided Imagery Intervention

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 8 years of age and no older than 80 years of age
  • Have clinical levels of anxiety
  • Report having asthma
  • Have asthma symptoms become triggered or exacerbated by anxiety

You may not qualify if:

  • Under 8 years old or older than 80 years old
  • No clinical levels of anxiety
  • No asthma symptoms triggered or exacerbated by anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaAnxiety Disorders

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Johanna M deLeyer-Tiarks, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 26, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share