Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?
NCT ID: NCT06020274
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-01
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Does the program improve the mental health such as depression and anxiety symptoms?
* Does the program improve overall quality of life?
* Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals?
Participants will:
* Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program
* Complete the online mental health program
* Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program
Participants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
NCT06012084
Group Cognitive Behavioural Therapy for Adults With Cystic Fibrosis
NCT06645782
Pilot Study of a CF-specific CBT Intervention for Adolescents
NCT05271643
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
NCT01686672
Project UPLIFT to Reduce Anxiety and Depression in CF Patients
NCT03139266
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
PARTICIPANTS: G\*Power 3.1 was used to calculate the study sample size based upon on our primary analyses (i.e., mixed model analysis of variance ANOVA\]). Assuming 80% power, an alpha of 0.05, and effect size of 0.25 (small to medium effect), a sample size of at least 24 participants in each group would be needed. The investigators aim to recruit 30 participants per group to address attrition. 60 children (ages 8 to 12 years) with CF and 60 child siblings (ages 8 to 12 years) will be recruited from the CF clinics and CF Chapters, CF advocacy groups, advocacy groups for pediatric chronic illness across Canada in a 1-year prospective study. Participants will be randomly assigned to either the iCF-PWR group or the standard care group. The investigators will seek to have equal representation of gender across both groups. 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.
HYPOTHESES:
1. The iCF-PWR group will have significant reductions in self-reported anxiety symptoms from pre- to post-program and at follow-up time points compared to the standard care group.
2. The iCF-PWR group will have significant reductions in self-reported depressive symptoms from pre- to post-program and at follow-up time points compared to the standard care group.
3. The iCF-PWR group will have significant reductions in self-reported health anxiety from pre- to post-program and at follow-up time points compared to the standard care group.
4. The iCF-PWR group will have significant improvements in self-reported quality of life from pre- to post-program and at follow-up time points compared to the standard care group.
5. The iCF-PWR group will have significant improvements in self-reported self-efficacy from pre- to post-program and at follow-up time points compared to the standard care group.
METHODS/PROCEDURES: Parent/guardian will be provided an overview of procedure in initial email. Via Qualtrics (i.e., online survey platform) (1) parent/guardian will be asked to complete consent form/facilitate the endorsement of assent form with child and complete and complete a short personal/health demographics questionnaire about themselves and their child, and (2) their child will be asked to complete a series of self-report questionnaires assessing anxiety, depression, health anxiety, quality of life, self-efficacy, and disease knowledge (pre-program measurement). The parent caregiver will help facilitate the child's completion of questionnaires. Parent will be asked to complete measures of parent-rated child anxiety and depression. This will take 5 minutes. Via email, child and parent/guardian will be provided a link to complete these measures once the program is completed (post-program measurement) and at two follow-up time points (1 month and 3 months post-program). Measure of satisfaction will be completed by child at post-program as well. Measures will take approximately 30 to 40 minutes to complete at each time-point. Similar time-points for measure completion will be used for both study groups (i.e., iCF-PWR and standard care groups). However, the satisfaction questionnaire will not be completed by standard care group.
Parents are encouraged to review the program along with their child and then children are encouraged to complete the program at least 1 additional time, with an overall program completion ranging from 3 to 6 weeks. Children can review the program as many times as they would like. Once enrolled, parent caregiver will be provided with a username/password. Parents/participants will be instructed to keep their username/password private. They will also be encouraged to access the program in a private area, preferably in their own homes. A contact e-mail will be given for technical support and instructions on how to operate the site. All contact with the parents/participants will be via e-mail during program, although a phone number will also be provided. Inquiries via email and telephone will be fielded by study coordinator. A reminder e-mail will be sent to parents if child has not logged onto the program at least 1x/week.
ANALYSES: Statistical analyses will be performed using IBM SPSS Statistics-Version 26. Demographic data will be summarized as means and standard deviations for continuous data and frequencies for categorical data. Preliminary analyses will explore the potential impact of demographic variables (e.g., age, gender) on primary and secondary outcome variables. If demographic variables have a statistically significant impact on outcome measures, those variables will be included as covariate(s) in primary and secondary analyses. An intention-to-treat (ITT) design will be employed for all primary and secondary analyses. Primary analyses will be three 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs. post-program vs. 1 month follow-up vs. 3 months follow-up) multi-level modeling (equivalent to mixed- model ANOVAs) to examine the effect of the intervention on the primary outcome measures (i.e., anxiety, depression, health anxiety). Secondary analyses will be two 2 (group: iCF-PWR vs standard care) x 4 (time of assessment: pre-program vs post-program vs 1 month follow-up vs 3 months follow-up) multilevel modeling to examine the effect of the intervention on the secondary outcome measures (i.e., quality of life, self-efficacy).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iCF-PWR Program
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.
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
The iCF-PWR program is a self-guided mental health prevention program designed for families with CF. Upon logging on to the iCF-PWR, the viewer will see two paths (i.e., child with CF or sibling) and will be encouraged by program narrator to choose the appropriate path. Each pathway (i.e., child with CF or sibling) is comprised of five text/voice-delivered, animated, interactive modules: (1) CF education, (2) CF health, (3) emotions and CF, (4) cognitive behaviour model of emotions, and (5) coping strategies. Each module takes 15-20 minutes to complete.
Standard Care
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
The iCF-PWR program is a self-guided mental health prevention program designed for families with CF. Upon logging on to the iCF-PWR, the viewer will see two paths (i.e., child with CF or sibling) and will be encouraged by program narrator to choose the appropriate path. Each pathway (i.e., child with CF or sibling) is comprised of five text/voice-delivered, animated, interactive modules: (1) CF education, (2) CF health, (3) emotions and CF, (4) cognitive behaviour model of emotions, and (5) coping strategies. Each module takes 15-20 minutes to complete.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* have a CF diagnosis or are a sibling of a child with CF
* can speak and read English. The research team does not have competence in other languages, further our program is delivered in English
Exclusion Criteria
8 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saskatchewan Health Authority - Regina Area
OTHER
Provincial Health Services Authority
OTHER
University of Regina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristi D Wright, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Regina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BC Children's Hospital
Vancouver, British Columbia, Canada
Saskatchewan Health Authority
Regina, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
Quittner AL, Abbott J, Georgiopoulos AM, Goldbeck L, Smith B, Hempstead SE, Marshall B, Sabadosa KA, Elborn S; International Committee on Mental Health; EPOS Trial Study Group. International Committee on Mental Health in Cystic Fibrosis: Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus statements for screening and treating depression and anxiety. Thorax. 2016 Jan;71(1):26-34. doi: 10.1136/thoraxjnl-2015-207488. Epub 2015 Oct 9.
Jamieson N, Fitzgerald D, Singh-Grewal D, Hanson CS, Craig JC, Tong A. Children's experiences of cystic fibrosis: a systematic review of qualitative studies. Pediatrics. 2014 Jun;133(6):e1683-97. doi: 10.1542/peds.2014-0009.
Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.
Smith BA, Georgiopoulos AM, Quittner AL. Maintaining mental health and function for the long run in cystic fibrosis. Pediatr Pulmonol. 2016 Oct;51(S44):S71-S78. doi: 10.1002/ppul.23522.
Goldbeck L, Fidika A, Herle M, Quittner AL. Psychological interventions for individuals with cystic fibrosis and their families. Cochrane Database Syst Rev. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3.
Pinquart M, Shen Y. Depressive symptoms in children and adolescents with chronic physical illness: an updated meta-analysis. J Pediatr Psychol. 2011 May;36(4):375-84. doi: 10.1093/jpepsy/jsq104. Epub 2010 Nov 18.
Fauman KR, Pituch KJ, Han YY, Niedner MF, Reske J, LeVine AM. Predictors of depressive symptoms in parents of chronically ill children admitted to the pediatric intensive care unit. Am J Hosp Palliat Care. 2011 Dec;28(8):556-63. doi: 10.1177/1049909111403465. Epub 2011 Mar 30.
Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
Barrett PM, Farrell LJ, Ollendick TH, Dadds M. Long-term outcomes of an Australian universal prevention trial of anxiety and depression symptoms in children and youth: an evaluation of the friends program. J Clin Child Adolesc Psychol. 2006 Sep;35(3):403-11. doi: 10.1207/s15374424jccp3503_5.
O'Donohue WT, Draper C. The case for evidence-based stepped care as part of a reformed delivery system. In Draper C, O'Donohue WT (Eds), Stepped Care and e-Health. Practical Applications to Behavioral Disorders.Springer:1-16.
Wright KD, Switzer H, Power HA et al. Canadian research: Mental health needs of children and adolescents with CF, and their families. Presented at the Western Canadian Cystic Fibrosis Conference, Saskatoon, SK, 2020, September.
Spielberger CD, Edwards CD, Montuori J, et al. State-Trait Anxiety Inventory for Children. Palo Alto, CA: Consulting Psychologist Press;1973.
Kovacs M. Children's depression inventory-2. New York: Multi-Health System. 2011.
Wright KD, Asmundson GJ. Health anxiety in children: development and psychometric properties of the Childhood Illness Attitude Scales. Cogn Behav Ther. 2003;32(4):194-202. doi: 10.1080/16506070310014691.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
Muris P. A brief questionnaire for measuring self-efficacy in youths. J Psychopathol Behav Assess 2001;23:145-49.
Shain LM, Pao M, Tipton MV, Bedoya SZ, Kang SJ, Horowitz LM, Wiener L. Comparing Parent and Child Self-report Measures of the State-Trait Anxiety Inventory in Children and Adolescents with a Chronic Health Condition. J Clin Psychol Med Settings. 2020 Mar;27(1):173-181. doi: 10.1007/s10880-019-09631-5.
Miles M, Huberman M. An Expanded Source Book: Qualitative Data Analysis. California: Sage Publications. 1994.
Morse J, Field P. Qualitative research methods for health professionals. California: Sage Publications. 2005.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-166
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.