Pilot of a therapist-guided internet-delivered cognitive behavioral therapy intervention for anxiety and depression (eHealth CF-CBT) in Dutch adults with Cystic Fibrosis

Recruiting

• Conditions: Cystic Fibrosis

• Registration Number: NL-OMON23818
• Lead Sponsor: Dutch Cystic Fibrosis Foundation (NCFS)

Brief Summary

n.a.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Diagnosis of CF, under medical care at Amsterdam UMC-AMC-site. Age: = 18 yrs.; willing/able to give informed consent. Scores on the Generalized Anxiety Disorder Scale (GAD-7) for anxiety and/or Patient Health Questionnaire (PHQ-9) for depression in the mild or moderate range (scores 5-14), without either score above moderate range (>15).

Subjects will not be excluded for the following reasons: CF severity or transplant status, if otherwise able to participate. If subjects are medically hospitalized, they may continue to participate.
-A history of more severe depression or anxiety currently at mild to moderate levels with or without treatment. This is important to best replicate real-world conditions during depression/anxiety screening in CF Centers to ensure broader generalizability of the intervention.
-Participation in concomitant psychosocial treatments (with the exception of formal CBT) or psychopharmacologic treatments at baseline, although these will be tracked and considered in analysis.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
Inability to read, write, and/or follow instructions in Dutch; or no internet access.
Severe psychiatric dysfunction, including acute safety risk to self or others. Subjects reporting suicidality on question 9 on the PHQ-9 will be further assessed. Those reporting suicidal intent will be excluded and referred for urgent/emergent care as indicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will calculate frequency and percentages of feasibility and acceptability scores and summarize the themes of our qualitative data. The differences between baseline and post-intervention will be analyzed.