Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

National Jewish Health31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety Depression Stress Coping Skills Cystic Fibrosis

Interventions

Cognitive Behavioral Stress ManagementBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

National Jewish Health

Denver, Colorado, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Week 0, 2, 4, 6, 8, 20