Biofeedback for Asthma Comorbid With Anxiety or Depression

NCT03030326 | Withdrawn

• 1 other identifier: 20160001007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

ASTHMA; ANXIETY

Outcome Measures

Primary Outcomes (3)

• change in asthma control test

  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.

  From pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover)

• change in Beck Anxiety Inventory

  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.

  Pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover)

• change in Beck Depression Inventory

  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.

  Pretest to 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover)

Secondary Outcomes (7)

• change in forced oscillation pneumography (resistance to 5 - 35 Hz sound stimulation

  Pretest to approximately 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover)

• Daily symptoms throughout participation in the study ( changes over 6 months)

  Daily from pretest to last session, approximately 6 months

• Home peak flow readings taken twice daily between 1st and last sessions (changes over 6 months) each subject

  At pretest and daily for 6 months of participation in the study

• 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)

  At pretest and at 3 and 6 months (after the treatment or waiting list phase, respectively, repeated at crossover)

• Low frequency heart rate variability

  At pretest and 3 and 6 months (changes within session and over time) after the treatment or waiting list phase, respectively, repeated at crossover)

Study Arms (2)

Heart rate variability biofeedback

EXPERIMENTAL

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

Observation first

NO INTERVENTION

This group will be observed during the first three months and given biofeedback during the second three months

Interventions

heart rate variability biofeedback BEHAVIORAL

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.

Heart rate variability biofeedback

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Asthma; Anxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Study Officials

• Paul Lehrer, PhD

  Rutgers Health Sciences IRB - New Brunswick/ Piscataway campus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: January 25, 2017
• Study Start: December 10, 2018
• Primary Completion: April 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 12, 2018

Record last verified: 2018-12