Back to resultsTelehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Primary Purpose
Anxiety, Depression, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Stress Management
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
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)
Sites / Locations
- National Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telehealth
Treatment-As-Usual (TAU)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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).
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03560726
Brief Title
Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Official Title
Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Jewish Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Stress, Coping Skills, Cystic Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehealth
Arm Type
Experimental
Arm 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.
Arm Title
Treatment-As-Usual (TAU)
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Stress Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (patient perspective)
Description
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)
Title
Feasibility (clinician perspective)
Description
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
Title
Acceptability (patient perspective 1 of 2)
Description
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
Title
Acceptability (patient perspective 2 of 2)
Description
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
Title
Satisfaction (patient perspective 1 of 2)
Description
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.
Time Frame
Week 8
Title
Satisfaction (patient perspective 2 of 2)
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Anxiety symptom improvement
Description
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
Title
Depression symptom improvement
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CJ Bathgate, PhD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34366282
Citation
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.
Results Reference
derived
Learn more about this trial
Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
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