Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 108
- Locations
- 8
- Primary Endpoint
- Prevalence of depression in patients with CF ages 14 to 17 and their parent caregivers
Study Overview
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.
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with CF
- •14 to 17 year old
- •Parents of a included patient
Exclusion Criteria
- •- Patient who have received an organ transplant shall be excluded.
Outcomes
Primary Outcomes
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 \[0-21\]
Secondary Outcomes
- 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)
- Number of exacerbations over the ensuing year(12 months)
- Number of hospitalizations over the ensuing year(12 months)