Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
April 17, 2018 updated by: Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Behavioral Activation Intervention
All eligible participants will undergo the 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Control Test
Time Frame: 4 weeks
|
Changes in asthma control over a 4 week period.
|
4 weeks
|
|
Urticaria Control Test
Time Frame: 4 weeks
|
Changes in urticaria control over a 4 week period.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Quality of Life Questionnaire
Time Frame: 4 weeks
|
Changes in asthma quality of life over a 4 week period.
|
4 weeks
|
|
Urticaria Activity Score Questionnaire
Time Frame: 4 weeks
|
Changes in the activity of urticaria over a 4 week period.
|
4 weeks
|
|
Psychological Measures (Composite)
Time Frame: 4 weeks
|
Effects of brief behavioral activation intervention based upon psychological differences including depression and anxiety measured over a 4 week period.
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immune biomarkers
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gailen D Marshall, Jr., MD, PhD, University of Mississippi Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
October 17, 2016
Study Registration Dates
First Submitted
March 2, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 6, 2015
Study Record Updates
Last Update Posted (Actual)
April 19, 2018
Last Update Submitted That Met QC Criteria
April 17, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-0340
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.