Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis

NCT03424486 | Completed

• 1 other identifier: NI17007JJ
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 8

Brief Summary

The Impact of cystic fibrosis (CF) on psychological and emotional functioning has been the focus of several studies over the past 20 years. The results from a current meta-analysis indicated that depressed patients were three times more likely to be noncompliant with treatment recommendations than nondepressed patients with chronic illness. To date, most studies of the prevalence of psychiatric symptoms have been limited by small sample size; reliance on samples of convenience that are potentially biased in term of rates of symptomatology, and measures that contain legitimate symptoms that are part of the respondent's chronic disease. Estimating the prevalence of depression and anxiety has become important as new evidence indicates that these symptoms may have a significant impact on health outcomes, including adherence to medical treatments, utilization of health care services, and rates of morbidity and mortality. More depressive the symptoms are associated with poorer lung function, and that in the absence of depression, poor lung function is minimally associated with lower patient ratings of quality of life. The purpose of the current study is to estimate the regional, and if possible the national prevalence of depressive and anxious symptoms in children and adults with CF and parents caregivers. Patients with CF ages 14 to 17, and parents of children ages 14 to 17, will complete and depression/anxiety screening measure at a routine clinic visit. These will then be linked with demographic and medical variables reported to the CF registry and analyzed cross sectionally. Adults with CF ages 18 and older will also complete the depression / anxiety screening measure at a routine clinic visit. Efforts will be made to recruit a representative sample of patients from each clinic.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Anxiety; Depression; Adolescence

Outcome Measures

Primary Outcomes (1)

• Prevalence of depression in patients with CF ages 14 to 17 and their parent caregivers

  The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at the inclusion (Day 1) : the depression HADS score \[0-21\]

  at inclusion (1 day)

Secondary Outcomes (7)

• Identification of the risk factors associated with symptoms of depression

  at the inclusion (1 day)

• Identification of the risk factors associated with symptoms of anxiety

  at the inclusion (1 day)

• Measure of the Quality of life of adolescents with CF (14-17)

  at the inclusion (1 day)

• Change in FEV1 over the ensuing year

  12 months

• Change in BMI over the ensuing year

  12 months

Study Arms (2)

Adolescents (14 to 17 years old)

Patients with CF

Other: Questionnaires

Parents

Parents of adolescents (14 to 17 years old with CF (father, mother and other)

Other: Questionnaires

Interventions

Questionnaires OTHER

Evaluation of the prevalence of anxiety, depression and quality of life

Adolescents (14 to 17 years old); Parents

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with CF aged 14 to 17. Patients awaiting organ transplantation will be included in the study, but those who have received an organ transplant shall be excluded. No other exclusionary criteria will be used. 2. Parents of the patients included.

You may qualify if:

• Patient with CF
• to 17 year old
• Parents of a included patient

You may not qualify if:

• \- Patient who have received an organ transplant shall be excluded.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Vaincre la Mucoviscidose: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (8)

Department of Pneumology - CRCM- Necker - Enfants malades Hospital (AP-HP) -

Paris, Paris, 75015, France

Location

CRCM - Service de Pneumologie Pédiatrique - CHU Amiens - Site Sud

Amiens, 80000, France

Location

CRCM Enfants - Service de Pneumologie - Hôpital Jean Minjoz

Besançon, 25000, France

Location

CRCM Pédiatrique - Hôpital des Enfants

Bordeaux, 33000, France

Location

CRCM - Service de Pédiatrie - Pôle FEH - CHU Caen)

Caen, 14000, France

Location

CRCM / Service de Médecine Infantile - Hôpital d'Enfants - CHRU Nancy

Nancy, 54511, France

Location

CRCM - Service de Pédiatrie A - American Memorial Hospital

Reims, 51100, France

Location

CRCM / Service de Pédiatrie _ Hôpital de Clocheville - CHRU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Anxiety Disorders; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• MAYA KIRSZENBAUM, MsD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: February 7, 2018
• Study Start: November 23, 2017
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

FR (8)