Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

National Jewish Health

Status: Completed

Conditions: Coping Skills; Cystic Fibrosis; Depression; Anxiety; Stress

Treatments: Behavioral: Cognitive Behavioral Stress Management

Study type: Interventional

Funder types: Other

Identifiers

NCT03560726

3143

Details and patient eligibility

About

The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old
• Fluent in English
• Diagnosed with Cystic Fibrosis
• Colorado resident
• Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
• Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
• Access to private email to complete surveys
• Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))

Exclusion criteria

• Currently receiving therapy or counseling with an outside provider for a mental health condition
• Currently in treatment for alcohol or substance abuse
• Unstable medical condition (not including cystic fibrosis)
• Neurological disease
• Pregnant women
• Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Telehealth

Experimental group

Description:

Participants randomized into the telehealth arm will receive up to 7 one-hour telehealth visits with the study psychologist. The first six sessions will focus on cognitive behavioral stress management topics and the seventh session is optional, focusing on lung transplant readiness. Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20). Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20.

Treatment:

Behavioral: Cognitive Behavioral Stress Management

Treatment-As-Usual (TAU)

No Intervention group

Description:

Participants randomized into the TAU arm will not receive any telehealth visits during the 8-week intervention phase. Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20). Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20.