Internet-Based Mental Health Program for Cystic Fibrosis

(iCF-PWR Trial)

Not yet recruiting at 1 trial location

Overseen By Dainelle M Caissie, M.Sc.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe cognitive impairment, major comorbid illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an internet-based mental health program for children with cystic fibrosis (CF) and their healthy siblings. The goal is to determine if the program can improve mental health, quality of life, and self-efficacy, which is the belief in one's ability to achieve goals. Participants will complete online surveys and the mental health program, called the Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program. Researchers will compare their progress to those on a waitlist receiving usual CF care. This trial suits children aged 8-12 who have CF or are siblings of someone with CF and can read and speak English. As an unphased trial, this study offers a unique opportunity to contribute to developing innovative mental health resources for children with CF and their families.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on an online mental health program, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that this Internet-based mental health program is safe for children and adolescents with cystic fibrosis?

Research has shown that online mental health programs like the iCF-PWR are generally safe and easy to use. These programs are designed to be simple and do not involve any physical procedures. Being online, participants can engage from home, often resulting in fewer reported issues.

Previous studies on similar online mental health programs have indicated a low risk of negative side effects. These programs focus on improving mental well-being, offering supportive and educational content rather than stressful material. This makes them a safe option for children and teens, including those with cystic fibrosis and their siblings.

Overall, the iCF-PWR program aims to enhance mental health without causing harm, making it a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iCF-PWR program is unique because it offers a convenient, internet-based approach to supporting the mental health of children with cystic fibrosis (CF) and their families. Unlike traditional mental health support, which typically involves in-person therapy sessions, this program allows users to access resources and complete modules at their own pace from the comfort of their home. Researchers are excited about this program because it can be tailored to individual needs, aiming to prevent mental health issues before they become more serious, and it integrates seamlessly with standard CF care. This accessibility and flexibility could make mental health support more manageable for families already dealing with the complexities of CF.

What evidence suggests that the iCF-PWR program is effective for improving mental health in children and adolescents with cystic fibrosis?

Research has shown that online mental health programs, such as the iCF-PWR program, can effectively assist children and teens with cystic fibrosis (CF). Studies have found that online cognitive-behavioral therapy (CBT) increases access to mental health care and can improve issues like depression and anxiety. The iCF-PWR program is specifically designed for CF, addressing the unique needs of these patients. It employs a flexible approach that adjusts to individual needs. Early results suggest improvements in mental health, confidence in handling challenges, and overall quality of life. This makes the iCF-PWR a promising option for supporting the mental health of young people with CF and their siblings. ^{1 3 5 6 7}

Who Is on the Research Team?

Kristi D Wright, Ph.D.

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 8-12 who either have cystic fibrosis (CF) or are siblings of someone with CF. They must be able to speak and read English. It's not suitable for those with severe cognitive impairments or major medical/psychiatric conditions that could limit participation.

Inclusion Criteria

I can speak and read English.

I am between 8 and 12 years old.

I have cystic fibrosis or my sibling does.

Exclusion Criteria

I do not have severe cognitive issues or major illnesses that would prevent me from participating fully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Completion

Participants complete the online mental health program, which includes reviewing modules and additional mental health resources

3-6 weeks

Online access

Follow-up

Participants are monitored for changes in mental health, quality of life, and self-efficacy at 1-month and 3-months post-program

3 months

Online surveys at 1-month and 3-months

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program

Trial Overview The trial tests an Internet-delivered mental health program designed for kids with CF and their healthy siblings. It evaluates the program's impact on depression, anxiety, quality of life, self-efficacy, and knowledge about CF compared to usual treatment over several months.

How Is the Trial Designed?

Group I: iCF-PWR Program Experimental Treatment 1 Intervention

Parents are encouraged to review the program along with their child and then children are encouraged to complete the program 1-2 additional times (or as many times as they like). It is suggested that modules be completed at a rate of 1-2 per week, with program completion ranging from 3-6 weeks. Additional mental health resources are provided at the end of the program.

Group II: Standard Care Active Control 1 Intervention

Participants will continue to receive their usual standard care related to CF (i.e., accessing services through their local health authority and CF clinic). Following the proposed maximum program completion time-frame (i.e., 6 weeks) and follow-up time period (i.e., 3 months), those in the standard care groups will be provided access to iCF-PWR.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Saskatchewan Health Authority - Regina Area

Collaborator

Trials

29

Recruited

5,400+

Provincial Health Services Authority

Collaborator

Trials

40

Recruited

31,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06020274

Internet-delivered Cystic Fibrosis Mental Health Prevention ... The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for children and adolescents with ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06012084/the-development-and-evaluation-of-icf-pwr-for-healthy-siblings-of-individuals-with-cystic-fibrosis

The Development and Evaluation of iCF-PWR for Healthy ... The overall goal of the project is to evaluate a recently developed evidence-based, Internet-delivered mental health prevention program for ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06020274?keyword=%22Internet-based%20Intervention%22

Internet-delivered Cystic Fibrosis Mental Health Prevention ... The program was designed with a stepped-care model in mind, whereby all children with CF and their child siblings could access and benefit from this ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8010637/

Development and evaluation of an internet-based cognitive ... A CF-specific internet-based cognitive-behavioral therapy (CBT) intervention was developed to increase access to evidence-based mental health care.

5. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/12/1/e002606

Psychosocial and mental health in cystic fibrosis in the ... Health outcomes in CF are influenced by a complex interplay of biological, psychological and social (biopsychosocial) factors across the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815457/

Psychosocial and mental health in cystic fibrosis in the ... CF continues to create psychological and social challenges for people with CF (PWCF) throughout their life and is associated with worse health outcomes and ...

7. icf-pwr.ca icf-pwr.ca/

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