Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Anxiety; Cystic Fibrosis; Coping Skills
• Intervention / Treatment: Behavioral: Cognitive Behavioral Stress Management

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth; 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.	Behavioral: Cognitive Behavioral Stress Management; Cognitive behavioral stress management is a well-established, practical intervention that combines elements of cognitive behavioral therapy with techniques designed to improve coping skills, social support, communication, and relaxation/mindfulness.
No Intervention: Treatment-As-Usual (TAU); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (patient perspective)	Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., number of people interested and consented into the study).	Week 0 (baseline)
Feasibility (clinician perspective)	Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the clinician perspective using the Structured Assessment of Feasibility (SAFE; 16 items). The first 8 items provide information about barriers to implementation and the second 8 items provide information about enablers to implementation. It is recommended that no overall summary score be used, as this scale is designed to highlight barriers and facilitators that future programs should consider if they decide to continue or begin implementing this intervention.	Week 8
Acceptability (patient perspective 1 of 2)	Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., telehealth sessions completed, dropouts).	Week 8
Acceptability (patient perspective 2 of 2)	Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using the Acceptability Scale (12 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study. A mean acceptability score will be computed from these 12 items.	Week 8
Satisfaction (patient perspective 1 of 2)	Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective. Satisfaction measured using the Satisfaction Scale (8 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study. A mean satisfaction score will be computed from the 8 items.	Week 8
Satisfaction (patient perspective 2 of 2)	Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using 4 open-ended questions designed specifically for this study. A qualitative summary will be provided based on responses to the open ended questions.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptom improvement	Assess changes in anxiety throughout study using the Generalized Anxiety Disorder 7-item Scale (GAD-7), which asks participants to rate how much they have been bothered by anxiety symptoms over the past 2 weeks (7 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day). A total score will be created by summing the scores of the 7 items.	Week 0, 2, 4, 6, 8, 20
Depression symptom improvement	Assess changes in depression throughout study using the Patient Health Questionnaire 9-item Scale (PHQ-9), which asks participants to rate how much they have been bothered by depression symptoms over the past 2 weeks (9 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day). A total score will be created by summing the scores of the 9 items.	Week 0, 2, 4, 6, 8, 20

Collaborators and Investigators

• Sponsor: National Jewish Health
• Investigators: Principal Investigator: CJ Bathgate, PhD, National Jewish Health

Publications and helpful links

General Publications

• Bathgate CJ, Kilbourn KM, Murphy NH, Wamboldt FS, Holm KE. Pilot RCT of a telehealth intervention to reduce symptoms of depression and anxiety in adults with cystic fibrosis. J Cyst Fibros. 2022 Mar;21(2):332-338. doi: 10.1016/j.jcf.2021.07.012. Epub 2021 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 3143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No