Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03424486 |
| Other study ID # |
NI17007JJ |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 23, 2017 |
| Est. completion date |
July 11, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
1. 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.
2. 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.
3. 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.
