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Biofeedback for Asthma Comorbid With Anxiety or Depression (ASANX)

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ClinicalTrials.gov Identifier: NCT03030326
Recruitment Status : Not yet recruiting
First Posted : January 25, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Lehrer, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:
Twenty patients with a history of treatment, within the past year, of both asthma and either depression or an anxiety disorder will be recruited for this study. Patients will be recruited from their doctors and from advertisements. The investigators will randomly assign patients to two groups, using a crossover design. One group will first receive three months with four biweekly sessions of heart rate variability biofeedback treatment, and then will be followed for three months with a daily symptom diary. The other group will first be followed for three months, and then given the three months of treatment. In both treatment and following procedures, patients will receive psychophysiological testing sessions at the beginning and end of the three month period. The investigators will assess symptoms of asthma, anxiety, and depression as well as pulmonary function and will measure heart rate (from electrodes on the wrists), respiration (through a belt around the waist), end tidal carbon dioxide (through a cannula in the nose).

Condition or disease Intervention/treatment Phase
ASTHMA ANXIETY Behavioral: heart rate variability biofeedback Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biofeedback for Asthma Comorbid With Anxiety or Depression
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Asthma

Arm Intervention/treatment
Experimental: Heart rate variability biofeedback
This group will receive treatment in the first three months of the study and will be observed during the second three months
Behavioral: heart rate variability biofeedback
Patients learn to increase heart rate variability by breathing at the resonance frequency of the cardiovascular system, at approximately 6 breaths/min, varying among people.

No Intervention: Observation first
This group will be observed during the first three months and given biofeedback during the second three months



Primary Outcome Measures :
  1. change in asthma control test [ Time Frame: From pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    paper and pencil scale of asthma symptoms. This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.

  2. change in Beck Anxiety Inventory [ Time Frame: Pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    paper and pencil scale of anxiety symptoms. This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.

  3. change in Beck Depression Inventory [ Time Frame: Pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    paper and pencil scale of depression symptoms. This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.


Secondary Outcome Measures :
  1. change in forced oscillation pneumography (resistance to 5 - 35 Hz sound stimulation [ Time Frame: Pretest to approximately 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    Patients will be tested for three minutes on a forced oscillation pneumograph after a 5-min rest period and after a 5-min biofeedback period (or self-relaxation, for patient who have not been trained yet)

  2. Daily symptoms throughout participation in the study ( changes over 6 months) [ Time Frame: Daily from pretest to last session, approximately 6 months ]
    Paper and pencil scale of asthma symptoms

  3. Home peak flow readings taken twice daily between 1st and last sessions (changes over 6 months) each subject [ Time Frame: At pretest and daily for 6 months of participation in the study ]
    Patients blow into a peak flow meter as hard and fast as possible, three times for each measure, once just after arising in the morning and one just before retiring in the evening

  4. Spirometry, where we measure FEV1 (changes over 6 months the volume of air exhaled during the first second of a forced expiratory maneuver from maximal vital capacity) [ Time Frame: At pretest and at 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    Patient blows into a peak flow meter as hard and fast as possible from the deepest breath possible three times at each assessment. This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.

  5. Low frequency heart rate variability [ Time Frame: At pretest and 3 and 6 months (changes within session and over time) after the treatment or waiting list phase, respectively, repeated at crossover) ]
    Spectral amplitude of interbeat cardiac intervals between 0.05 - 0.15 Hz recorded from the R-spike of the electrocardiogram. This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.

  6. End tidal carbon dioxide (CO2) [ Time Frame: Changes within session and over time, taken at pretest and 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover) ]
    Taken on a capnometer through a nasal canula immediately after each 5 -min task (baseline or biofeedback). This study uses a crossover design. the first post-test is at 3 months. Then the conditions are switched, such that the experimental group gets the control condition and the control group gets the experimental condition. The measure will then be taken 3 months later, i.e. at the 6 month period.

  7. Marlowe Crowne Social Desirability Scale [ Time Frame: Given only at the pretest session ]
    This is a suppressor variable not an outcome variable. It is given only once and used as a covariate for other measures



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma: A diagnosis of asthma within the past year, and any of the following: history of a previous positive methacholine challenge test, or history of a positive response to albuterol and/or inhaled or oral steroid medication. We only will accept patients whose asthma is not under complete control, so an additional criterion will be an Asthma Control Test score of < 19.
  • Age: 18-75.
  • Anxiety: A Beck Anxiety Scale score ≥ 10 (mild anxiety) and a history of medical or psychological treatment of anxiety within the past year.

Exclusion Criteria:

  • Comorbid disease. A diagnosed lung disease other than asthma, a cardiac rhythm disturbance (e.g., frequent preventricular or preatrial contractions, mitral valve prolapse, active psychosis, taking antipsychotic medications, presence of other serious or life threatening disease (e.g., cancer, or serious renal, hepatic, cardiac, immunodeficiency, neurological, or other disease), epileptic seizure within the past year
  • Asthma Severity: Hospitalization for asthma within the past year.
  • Linguistic and intellectual competence. Inability to understand English, illiteracy, or mental incapacity, understand informed consent procedures, or complete questionnaires or follow procedures.
  • Smoking: Patients must be non-smokers for at least the past year and have less than a 15 pack-year smoking history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030326


Contacts
Contact: Paul Lehrer, PhD 732-235-4413 lehrer@rwjms.rutgers.edu

Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Study Director: Paul Lehrer, PhD Rutgers Health Sciences IRB - New Brunswick/ Piscataway campus

Responsible Party: Paul Lehrer, Ph.D., Professor of Psychiatry, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03030326     History of Changes
Other Study ID Numbers: 20160001007
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We hope to publish data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Asthma
Anxiety Disorders
Behavioral Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mental Disorders