Acceptance and Commitment Therapy for Chronic Cough

(FAST-COUGH Trial)

Overseen By Carolyn K. Novaleski, Ph.D., CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Ace inhibitors

Disqualifiers: Current smoking, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a prospective, single-center, single-arm pilot trial. The primary research question is whether brief, breath control-focused Acceptance and Commitment Therapy (ACT) is feasible, acceptable, and safe in adults with chronic cough.

Who Is on the Research Team?

Carolyn Novaleski, Ph.D., CCC-SLP

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

Inclusion Criteria

Completed outpatient clinical encounter within the prior 12 months with a provider in pulmonary medicine, gastroenterology, otolaryngology, and/or allergy at UNC Health via medical chart review, with documentation that chronic cough (lasting 8 weeks or longer) was listed as one of the reasons for the visit, with terminology such as chronic, ongoing, recurrent, persistent, lingering, refractory, longstanding, constant, continual, continuous, prolonged, intermittent, frequent, repetitive, unresolved, non-resolving, habitual, troublesome, bothersome, unmanaged, unexplained, idiopathic, progressive, worsening, treatment-resistant, and/or intractable

I am between 18 and 80 years old.

Score ≤ 14 on the Patient Health Questionnaire-9 (PHQ-9), indicating no greater than moderate depressive symptom severity (maximum score: 27), via self-report using a screening questionnaire

Exclusion Criteria

Current smoking status via medical chart review

I am currently taking an ACE inhibitor medication.

Unable to read, understand, and speak English without an interpreter via medical chart review

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brief, breath control-focused Acceptance and Commitment Therapy (ACT)

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT)

How Is the Trial Designed?

Group I: Acceptance and Commitment Therapy (ACT) Experimental Treatment 1 Intervention

Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+