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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02382562
Other study ID # 2014-0340
Secondary ID
Status Terminated
Phase N/A
First received March 2, 2015
Last updated April 17, 2018
Start date May 2015
Est. completion date October 17, 2016

Study information

Verified date April 2018
Source University of Mississippi Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Depression and other unhealthy behaviors, such as not taking medication as prescribed and not attending doctor visits have been suggested to increase the worsening of allergic diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral intervention is effective in helping with depression and controlling disease symptoms. We will measure this using pre- and post-intervention surveys.


Description:

The purpose of this research study is to investigate whether a one-session behavioral activation intervention for depression can successfully reduce depression and improve asthma or urticaria disease-relevant outcomes (medication adherence, doctor's visits, substance abuse) in clinical patients with asthma or urticaria who report heightened levels of depression and are seen in the UMMC Allergy Clinic.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date October 17, 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Potential participants should be between the ages 18 and 64, seen in the UMMC Allergy Clinic with either asthma or urticaria and who report symptoms of depression in the previous 2 weeks.

Exclusion Criteria:

- Potential participants younger than 18 and older than 64 or who do not speak English or cannot comprehend the consent form or women who are pregnant are excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Behavioral Activation Intervention
Clinical psychologists (investigators) will instruct the participant in ways to become more active in life, particularly with regards to activities that the participant finds pleasurable and meaningful. The intervention will take one hour to complete. Following the intervention, the participant will receive brief, weekly text or email reminders for the next 4 weeks (total of 4) to engage in pleasurable and meaningful activities during the week.

Locations

Country Name City State
United States University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic Jackson Mississippi

Sponsors (1)

Lead Sponsor Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Immune biomarkers Changes in Regulatory T (Treg), Type 1 Regulatory (Tr1), T helper (TH3), T helper 1 (TH1), T helper 2 (TH2), cells, Interferon gamma (IFNg), Interleukin 4 (IL4) and Interleukin 10 (IL10) cytokine production from baseline to 4 weeks. 4 weeks
Primary Asthma Control Test Changes in asthma control over a 4 week period. 4 weeks
Primary Urticaria Control Test Changes in urticaria control over a 4 week period. 4 weeks
Secondary Asthma Quality of Life Questionnaire Changes in asthma quality of life over a 4 week period. 4 weeks
Secondary Urticaria Activity Score Questionnaire Changes in the activity of urticaria over a 4 week period. 4 weeks
Secondary Psychological Measures (Composite) Effects of brief behavioral activation intervention based upon psychological differences including depression and anxiety measured over a 4 week period. 4 weeks
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