Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2020-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Anxiety Depression Stress Coping Skills Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telehealth

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Stress Management

Intervention Type 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.

Treatment-As-Usual (TAU)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No