Cystic FibrosisADMPE-2NCT03424486
Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Questionnaires
- How many people
- 108 participants
- Where
- 8 sitesFrance
- Study dates
- 23 Nov 2017to 11 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patient with CF
- 14 to 17 year old
- Parents of a included patient
Who cannot join
- Patient who have received an organ transplant shall be excluded.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CRCM - Service de Pneumologie Pédiatrique - CHU Amiens - Site Sud
Amiens, 80000
CRCM Enfants - Service de Pneumologie - Hôpital Jean Minjoz
Besançon, 25000
CRCM Pédiatrique - Hôpital des Enfants
Bordeaux, 33000
CRCM - Service de Pédiatrie - Pôle FEH - CHU Caen)
Caen, 14000
CRCM / Service de Médecine Infantile - Hôpital d'Enfants - CHRU Nancy
Nancy, 54511
Department of Pneumology - CRCM- Necker - Enfants malades Hospital (AP-HP) -
Paris, Paris, 75015
CRCM - Service de Pédiatrie A - American Memorial Hospital
Reims, 51100
CRCM / Service de Pédiatrie _ Hôpital de Clocheville - CHRU de Tours
Tours, 37000
About this study
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.
Read the detailed description
Numerous studies have demonstrated that patients with chronic illnesses are at increased risk for depression and anxiety. In large, well-controlled epidemiological studies, rates of depression in medical populations have ranged from 17% to 50% compared to 5% to 17.5% in healthy populations. Reporting on a community-based sample, Wells and colleagues concluded that individuals with a chronic medical condition have a 41% increase in the risk of having a psychiatric disorder as well.
In patients with chronic illnesses, depression and anxiety have been shown to have direct and indirect consequences for health outcomes, and this has been addressed in a recent ATS/ERS consensus statement on pulmonary rehabilitation. Depressed patients are less compliant with medical regimens, less likely to follow dietary regimes, more likely to cancel or miss clinic appointments, report worse functioning on several quality of life domains, have increased health care utilization and higher health care costs, and are also more likely to engage in risky behaviors, such as smoking, drinking and drug use.
To date, studies of the impact of depression and anxiety in patients with CF have been limited by small samples sizes, samples of convenience that may provide biased estimates of symptom rates, and have used measures that confound symptoms of depression with those of a chronic illness. Given the importance of identifying and treating these symptoms, and their implications for long-term health outcomes, the current study proposes to conduct the first national prevalence study of depression and anxiety in CF patients and parent caregivers. Furthermore, we plan to examine the impact of these psychological symptoms on health outcomes, such as pulmonary exacerbations and nutritional status.
- Anxiety and Depression are common in Cystic Fibrosis, but their exact prevalence is unknown. Specific Aim 1: To estimate the prevalence of depression and anxiety in patients with CF ages 14 to 17 and parent caregivers of those adolescents Of the few studies of school-age children and adolescents with CF, one reported a rate of depression ranging from 11% to 14.5% in contrast to a rate of 2-6% in the general pediatric population. Published rates of anxiety have ranged from 5% to 9% which may approximate that of the general childhood population. Furthermore, the rate of depression in parent caregivers is also high compared to parents of healthy children. In a multi-site adherence intervention trial of 88 parents of young children with CF, ages 1 to 11, 29% of parents scored in the clinical range on a depression screening tool. This is similar to a study of role strain in parents of young children with CF, in which 36.4% of the mothers' depressive symptoms fell within the clinical range. Furthermore, even higher rates of depression were reported in a study of parents soon after the diagnosis, with 64% of mothers and 43% of fathers scoring in the clinical range. Previous estimates of the prevalence of depression and anxiety in patients with CF have been hampered by serious methodological limitations, such as small sample size, convenience sampling that is potentially biased, and the use of diagnostic screening instruments that attribute somatic symptoms to a depressive disorder which may be due to having a chronic illness like CF (e.g., fatigue). Furthermore, studies of depression and anxiety in pediatric CF populations have not considered developmental and gender differences in depression that emerge in the general population during adolescence.
- Identifying patients and parents at risk for depression and anxiety disorders is important, but risk factors in the CF population are not known. Specific Aim 2: To identify risk factors associated with symptoms of depression and anxiety. This study was cross-sectional, making it impossible for the authors to distinguish whether psychological symptoms preceded or followed patients' employment status, or how either of these might have been related to changes in health outcomes.
- Anxiety and depression probably lead to worse clinical outcomes in CF, but this has not been evaluated.
Specific Aim 3: To evaluate how depression and anxiety influence health outcomes (particularly number of exacerbations and hospitalizations, FEV1 and nutritional measures) over the ensuing year.
There is wide variability in the progression of disease in patients with CF, as reflected in the distribution of age at diagnosis, age-related pulmonary function, and age at death (Cystic Fibrosis Foundation Patient Registry, 2004). This variability is partially explained by CFTR mutation and gene modifiers, but environmental and sociodemographic factors, and variations in the use of various healthcare interventions are of equal or greater importance in explaining this variability in health outcomes.
- Conditions
- Cystic Fibrosis
- Being tested
- Questionnaires
- Keywords
- Cystic fibrosis, Anxiety, Depression, Adolescence
- Medical subject headings
- Cystic Fibrosis, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Evaluation of the prevalence of anxiety, depression and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Adolescents (14 to 17 years old) | Patients with CF Receives: Other: Questionnaires | |
| Parents | Parents of adolescents (14 to 17 years old with CF (father, mother and other) Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: at inclusion (1 day)
Secondary outcomes (7)
Identification of the risk factors associated with symptoms of depression
Symptoms of depression are assessed with the Center for Epidemiological Studies of Depression Scale (CES-D) : CES-D score [0-60]
Measured: at the inclusion (1 day)
Identification of the risk factors associated with symptoms of anxiety
The anxiety is assessed with the HADS scale : the anxiety HADS score [0-21]
Measured: at the inclusion (1 day)
Measure of the Quality of life of adolescents with CF (14-17)
The quality of life of adolescents is assessed with the Cystic Fibrosis Questionnaire (CFQ14+) : CFQ score
Measured: at the inclusion (1 day)
Change in FEV1 over the ensuing year
FEV1 (in % predicted)
Measured: 12 months
Change in BMI over the ensuing year
Weight (Kg) and height (m) will be combined to report BMI in kg/m2
Measured: 12 months
Number of exacerbations over the ensuing year
Number of exacerbations over the 12 last months to identify the risk factors associated with symptoms of depression and anxiety, and to evaluate the influence of depression and anxiety on CF health outcomes
Measured: 12 months
Number of hospitalizations over the ensuing year
Number of hospitalizations over the 12 last months to identify the risk factors associated with symptoms of depression and anxiety, and to evaluate the influence of depression and anxiety on CF health outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start23 Nov 2017
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- MAYA KIRSZENBAUM, MsD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424486
- Sponsor's protocol ID
- NI17007JJ
- Acronym
- ADMPE-2
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2017
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03424486
- Acronym / sponsor ID
- ADMPE-2 / NI17007JJ
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Anxiety, Depression, Adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Numerous studies have demonstrated that patients with chronic illnesses are at increased risk for depression and anxiety. In large, well-controlled epidemiological studies, rates of depression in medical populations have ranged from 17% to 50% compared to 5% to 17.5% in healthy populations. Reporting on a community-based sample, Wells and colleagues concluded that individuals with a chronic medical condition have a 41% increase in the risk of having a psychiatric disorder as well.
In patients with chronic illnesses, depression and anxiety have been shown to have direct and indirect consequences for health outcomes, and this has been addressed in a recent ATS/ERS consensus statement on pulmonary rehabilitation. Depressed patients are less compliant with medical regimens, less likely to follow dietary regimes, more likely to cancel or miss clinic appointments, report worse functioning on several quality of life domains, have increased health care utilization and higher health care costs, and are also more likely to engage in risky behaviors, such as smoking, drinking and drug use.
To date, studies of the impact of depression and anxiety in patients with CF have been limited by small samples sizes, samples of convenience that may provide biased estimates of symptom rates, and have used measures that confound symptoms of depression with those of a chronic illness. Given the importance of identifying and treating these symptoms, and their implications for long-term health outcomes, the current study proposes to conduct the first national prevalence study of depression and anxiety in CF patients and parent caregivers. Furthermore, we plan to examine the impact of these psychological symptoms on health outcomes, such as pulmonary exacerbations and nutritional status.
- Anxiety and Depression are common in Cystic Fibrosis, but their exact prevalence is unknown. Specific Aim 1: To estimate the prevalence of depression and anxiety in patients with CF ages 14 to 17 and parent caregivers of those adolescents Of the few studies of school-age children and adolescents with CF, one reported a rate of depression ranging from 11% to 14.5% in contrast to a rate of 2-6% in the general pediatric population. Published rates of anxiety have ranged from 5% to 9% which may approximate that of the general childhood population. Furthermore, the rate of depression in parent caregivers is also high compared to parents of healthy children. In a multi-site adherence intervention trial of 88 parents of young children with CF, ages 1 to 11, 29% of parents scored in the clinical range on a depression screening tool. This is similar to a study of role strain in parents of young children with CF, in which 36.4% of the mothers' depressive symptoms fell within the clinical range. Furthermore, even higher rates of depression were reported in a study of parents soon after the diagnosis, with 64% of mothers and 43% of fathers scoring in the clinical range. Previous estimates of the prevalence of depression and anxiety in patients with CF have been hampered by serious methodological limitations, such as small sample size, convenience sampling that is potentially biased, and the use of diagnostic screening instruments that attribute somatic symptoms to a depressive disorder which may be due to having a chronic illness like CF (e.g., fatigue). Furthermore, studies of depression and anxiety in pediatric CF populations have not considered developmental and gender differences in depression that emerge in the general population during adolescence.
- Identifying patients and parents at risk for depression and anxiety disorders is important, but risk factors in the CF population are not known. Specific Aim 2: To identify risk factors associated with symptoms of depression and anxiety. This study was cross-sectional, making it impossible for the authors to distinguish whether psychological symptoms preceded or followed patients' employment status, or how either of these might have been related to changes in health outcomes.
- Anxiety and depression probably lead to worse clinical outcomes in CF, but this has not been evaluated.
Specific Aim 3: To evaluate how depression and anxiety influence health outcomes (particularly number of exacerbations and hospitalizations, FEV1 and nutritional measures) over the ensuing year.
There is wide variability in the progression of disease in patients with CF, as reflected in the distribution of age at diagnosis, age-related pulmonary function, and age at death (Cystic Fibrosis Foundation Patient Registry, 2004). This variability is partially explained by CFTR mutation and gene modifiers, but environmental and sociodemographic factors, and variations in the use of various healthcare interventions are of equal or greater importance in explaining this variability in health outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents (14 to 17 years old) | – | Other: QuestionnairesPatients with CF |
| Parents | – | Other: QuestionnairesParents of adolescents (14 to 17 years old with CF (father, mother and other) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Patient with CF
- 14 to 17 year old
- Parents of a included patient
Key exclusion criteria (1 listed)
- Patient who have received an organ transplant shall be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesEvaluation of the prevalence of anxiety, depression and quality of life | Other | Adolescents (14 to 17 years old), Parents |
Primary outcome
Prevalence of depression in patients with CF ages 14 to 17 and their parent caregivers
Time frame: at inclusion (1 day)
The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at the inclusion (Day 1) : the depression HADS score [0-21]
7 secondary outcomes
Identification of the risk factors associated with symptoms of depression
Time frame: at the inclusion (1 day)
Identification of the risk factors associated with symptoms of anxiety
Time frame: at the inclusion (1 day)
Measure of the Quality of life of adolescents with CF (14-17)
Time frame: at the inclusion (1 day)
Change in FEV1 over the ensuing year
Time frame: 12 months
Change in BMI over the ensuing year
Time frame: 12 months
Number of exacerbations over the ensuing year
Time frame: 12 months
Number of hospitalizations over the ensuing year
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAYA KIRSZENBAUM, MsD principal investigator
Assistance Publique - Hôpitaux de Paris
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of depression in patients with CF ages 14 to 17 and their parent caregivers (time frame: at inclusion (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.