Chronic Lung DiseaseNCT03180164
Depression in Chronic Airways Diseases
A study testing hospital anxiety and depression scale in people with Chronic Lung Disease, run by Assiut University.
Trial summary
Chronic airways diseases involve alterations in the person's social roles, relationships and self-perception so demands continual psychological adjustment . Also Kunik studied patients with chronic breathing disorders for depression and anxiety and found that 65% of patients were positive for depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- hospital anxiety and depression scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Oct 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic airways diseases as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis
Who cannot join
- Diabetes Mellitus and Hypertension.
- Cardiac diseases.
- Chronic renal and liver diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anxiety and Depression in Chronic Airways Diseases
Chronic airways diseases involve alterations in the person's social roles, relationships and self-perception so demands continual psychological adjustment .
Also Kunik studied patients with chronic breathing disorders for depression and anxiety and found that 65% of patients were positive for depression and anxiety.
Shackell found that patients' anxiety and fears of breathlessness and dying extended into the night and were aggravated by feelings of isolation and frustration. One patient reported that they often thought 'am I going to see the next morning?'
Read the detailed description
This fear and sense of helplessness can lead to panic and evidence suggests that patients with chronic breathlessness often call for emergency assistance during the night According to GOLD report 2017, anxiety and depression in chronic obstructive pulmonary disease patients are both associated with poor prognosis.
Much of the evidence explored so far relates to chronic obstructive pulmonary disease. While other chronic lung diseases have received less attention In addition to, several studies have been found relationship between asthma and psychological disturbance .One review of literature describes an increased prevalence of psychological co-morbidity in asthmatic adults and another research suggests that anxiety and depression are more common in patients with moderate to severe asthma than in the general population Gift. found significantly greater self-reported depression scores among patients with chronic obstructive pulmonary disease receiving prednisone compared to patients not receiving any steroids.
Interestingly, the psychiatric sequel of steroid treatment are often sudden in onset and appear to generally occur within 2 weeks after steroid introduction
- Conditions
- Chronic Lung Disease
- Being tested
- hospital anxiety and depression scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospital anxiety and depression scaleOther
self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| chronic lung diseases | Other | bronchiectasis , bronchial asthma and chronic obstructive pulmonary disease assess anxiety and depression by hospital anxiety and depression scale Receives: Other: hospital anxiety and depression scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare anxiety and depression in different forms of chronic lung diseases
by hospital anxiety and depression scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fareda ahmed mohamed, Assiut University
- Investigators
- Reham Mohamed El-Morshedy, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180164
- Sponsor's protocol ID
- CLD
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depression in Chronic Airways Diseases
- ClinicalTrials.gov ID
- NCT03180164
- Acronym / sponsor ID
- CLD
- Conditions
- Chronic Lung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Jun 2017 (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.
Chronic airways diseases involve alterations in the person's social roles, relationships and self-perception so demands continual psychological adjustment .
Also Kunik studied patients with chronic breathing disorders for depression and anxiety and found that 65% of patients were positive for depression and anxiety.
Shackell found that patients' anxiety and fears of breathlessness and dying extended into the night and were aggravated by feelings of isolation and frustration. One patient reported that they often thought 'am I going to see the next morning?'
Detailed description
This fear and sense of helplessness can lead to panic and evidence suggests that patients with chronic breathlessness often call for emergency assistance during the night According to GOLD report 2017, anxiety and depression in chronic obstructive pulmonary disease patients are both associated with poor prognosis.
Much of the evidence explored so far relates to chronic obstructive pulmonary disease. While other chronic lung diseases have received less attention In addition to, several studies have been found relationship between asthma and psychological disturbance .One review of literature describes an increased prevalence of psychological co-morbidity in asthmatic adults and another research suggests that anxiety and depression are more common in patients with moderate to severe asthma than in the general population Gift. found significantly greater self-reported depression scores among patients with chronic obstructive pulmonary disease receiving prednisone compared to patients not receiving any steroids.
Interestingly, the psychiatric sequel of steroid treatment are often sudden in onset and appear to generally occur within 2 weeks after steroid introduction
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic lung diseases | Other | Other: hospital anxiety and depression scalebronchiectasis , bronchial asthma and chronic obstructive pulmonary disease assess anxiety and depression by hospital anxiety and depression scale |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chronic airways diseases as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis
Key exclusion criteria (3 listed)
- Diabetes Mellitus and Hypertension.
- Cardiac diseases.
- Chronic renal and liver diseases.
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 |
|---|---|---|
| hospital anxiety and depression scaleself-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic | Other | chronic lung diseases |
Primary outcome
compare anxiety and depression in different forms of chronic lung diseases
Time frame: 10 minutes
by hospital anxiety and depression scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Reham Mohamed El-Morshedy study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing hospital anxiety and depression scale in people with Chronic Lung Disease, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Ahmed El-Kholy (00201096956205, maha_elkholy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare anxiety and depression in different forms of chronic lung diseases (time frame: 10 minutes). 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 9 Jan 2018.