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

Pilot study eHealth CF-CBT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23818
Enrollment
10
Registered
2021-03-18
Start date
2021-03-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Interventions

Behavioural intervention eHealth CF-CBT in Minddistrict: As described below, the 8 modules of the online CF-CBT program are delivered through blended care: face-to-face/videocall contact with the

Sponsors

Dutch Cystic Fibrosis Foundation (NCFS)
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Contacts

Public ContactMarieke Verkleij

Amsterdam UMC/location VUmc

m.verkleij@amsterdamumc.nl+31 20 4440861

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)