Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients

Depression Clinical Trial

Official title:

Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02382562
• Other study ID #: 2014-0340
• 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
• 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.

Related Conditions & MeSH terms

• Asthma
• Depression
• Urticaria

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