NCT03560726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

May 3, 2018

Last Update Submit

September 8, 2020

Conditions

AnxietyDepressionStressCoping SkillsCystic Fibrosis

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Anxiety symptom improvement

    Week 0, 2, 4, 6, 8, 20

  • Depression symptom improvement

    Week 0, 2, 4, 6, 8, 20

Study Arms (2)

Telehealth

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Stress Management

Treatment-As-Usual (TAU)

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Stress ManagementBEHAVIORAL

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.

Telehealth

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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))

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

  • 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.

    PMID: 34366282DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionCystic Fibrosis

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • CJ Bathgate, PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licensed Clinical Psychologist

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 18, 2018

Study Start

June 4, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)