Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

Depression Clinical Trial

Official title:

Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560726
• Other study ID #: 3143
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: September 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Coping Skills
• Cystic Fibrosis
• Depression
• Fibrosis
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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