Anxiety, Coping Skills, Cystic Fibrosis, Depression, Stress
Conditions
Brief summary
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
National Jewish Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction (patient perspective 2 of 2) | Week 8 | 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. |
| Acceptability (patient perspective 2 of 2) | Week 8 | 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. |
| Satisfaction (patient perspective 1 of 2) | Week 8 | 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. |
| Feasibility (patient perspective) | Week 0 (baseline) | 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). |
| Feasibility (clinician perspective) | Week 8 | 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. |
| Acceptability (patient perspective 1 of 2) | Week 8 | Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., telehealth sessions completed, dropouts). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptom improvement | Week 0, 2, 4, 6, 8, 20 | 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. |
| Anxiety symptom improvement | Week 0, 2, 4, 6, 8, 20 | 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. |
Countries
United States
Outcome results
None listed