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Completed

NCT Number: NCT03560726

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coping Skills Cystic Fibrosis Depression Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mental Disorders Pancreatic Diseases Respiratory Tract Diseases Stress

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Stress Management

Behavioral

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 outcomes

  1. Feasibility (patient perspective)

    Time frame: 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).

  2. Feasibility (clinician perspective)

    Time frame: 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.

  3. Acceptability (patient perspective 1 of 2)

    Time frame: 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).

  4. Acceptability (patient perspective 2 of 2)

    Time frame: 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.

  5. Satisfaction (patient perspective 1 of 2)

    Time frame: 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.

  6. Satisfaction (patient perspective 2 of 2)

    Time frame: 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.

Secondary outcomes

  1. Anxiety symptom improvement

    Time frame: 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.

  2. Depression symptom improvement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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