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

Rationale: Adults with Cystic Fibrosis (CF) are at increased risk to develop depression and anxiety, with devastating consequences for health outcomes. Given international guidelines recommending routine screening, this project addresses an urgent need for new approaches to prevent and treat depression and anxiety in adults with CF. Drs. Verkleij, Friedman and Georgiopoulos have recently developed “eHealth CF-CBT”, a blended care program for adults with CF based on cognitive behavioural therapy that integrates therapist-guided online self-management modules with in-person sessions. The program is being developed in English and Dutch, with input from Dutch adults with CF and CF healthcare providers, and the Dutch Cystic Fibrosis Foundation.
Objective: The proposed pilot study will test the feasibility and acceptability of the Dutch eHealth CF-CBT program for adults with CF.
Study design: In this uncontrolled single-center pilot study, feasibility and acceptability, will be assessed, measuring pre-post changes in anxiety, depression, perceived stress, and health-related quality of life (HRQoL).
Study population: The intervention is targeted for adults with CF screening in the mild to moderate range on anxiety and/or depression measures. Participants will be recruited from a pool of 124 adult CF patients at AMC. We aim to enroll 10 patients in this study.
Intervention: The 8 modules of the online CF-CBT program are delivered through blended care: face-to-face/videocall contact with the psychologist in combination with online modules. At the intake, after four sessions and at the end, there will be a face-to-face/videocall session.
eHealth CF-CBT provides an opportunity to build skills to face current and future challenges in living with CF and increase quality of life. Individual barriers to CF self-management (e.g., negative medication beliefs) are addressed in multiple ways. Each module includes teaching on the session topic, a skill-building exercise, and a homework assignment to apply each skill in-between sessions. Experiential out-of-session exercises (e.g., relaxation practice) are a key component of CBT treatment programs with the goal of consolidating learning. The intervention is built into the online platform Minddistrict, which is an internet-based application enabling individuals to flexibly engage in mental health intervention. Minddistrict is approved as a secure information technology vendor for international use.
Main study parameters/endpoints: 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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with the investigational treatment. CBT is already a psychological evidence-based intervention. This study aims to improve emotional well-being and HRQoL with potential longitudinal impact on pulmonary exacerbations, hospitalizations, core health outcomes, and mortality.

Study Hypotheses:
We hypothesize that there will be:
1) High ratings of treatment acceptability (treatment satisfaction ratings) from participants
2) A reduction in depression (PHQ-9) and anxiety (GAD-7) symptoms, and perceived stress (PSS) scores from immediate pre- to post-eHealth CF-CBT measurement
3) An improvement in CF-specific HRQoL (CFQ-R) from immediate pre- to post-eHealth CF-CBT measurement.

Endpoint will be: finishing the 8 sessions of the eHealth CF-CBT program and completing the questionnaires.

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 psychologist in combination with online modules. At the intake, after four sessions and at the end, there will be a face-to-face/videocall session.
CF-CBT provides an opportunity to build skills to face current and future challenges in living with CF and increase quality of life. Individual barriers to CF self-management (e.g., negative medication beliefs) are addressed in multiple ways. Each module includes teaching on the session topic, a skill-building exercise, and a homework assignment to apply each skill in-between sessions. Experiential out-of-session exercises (e.g., relaxation practice) are a key component of CBT treatment programs with the goal of consolidating learning.
Content of sessions is as follows:
1) Overview and Introduction to CBT
2) Relaxation Skills
3) Depression in CF: What Helps?
4) Adaptive Thinking Skills, part 1
5) Adaptive Thinking Skills, part 2
6) Taking Charge of My Health
7) Anxiety in CF: What Helps?
8) Maintaining Positive Changes

Minddistrict (https://www.minddistrict.com/) is an internet-based application enabling individuals to flexibly engage in mental health intervention. Minddistrict is widely used in the Netherlands, including at Amsterdam UMC location VUmc and AMC, and will be inexpensive to embed in the CF care system. The Minddistrict eHealth format incorporates simple text, interactive text, audio and videos, easily integrating questionnaires, diaries, and clinician monitoring and feedback. Minddistrict is approved as a secure information technology vendor for international use. Participants receive online access for at least half a year after finishing the intervention, and can view and print their work. Interventionists have access to an administrator page allowing them to view patients’ progress and give feedback. Following completion, the CF psychologist can enter outcomes and follow up plans into the medical file to ensure continuity of care.