Back to resultsBrief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
Primary Purpose
Depression, Asthma, Urticaria
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Activation Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Asthma, Urticaria
Eligibility Criteria
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.
Sites / Locations
- University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brief Behavioral Activation Intervention
Arm Description
All eligible participants will undergo the Brief Behavioral Activation Intervention.
Outcomes
Primary Outcome Measures
Asthma Control Test
Changes in asthma control over a 4 week period.
Urticaria Control Test
Changes in urticaria control over a 4 week period.
Secondary Outcome Measures
Asthma Quality of Life Questionnaire
Changes in asthma quality of life over a 4 week period.
Urticaria Activity Score Questionnaire
Changes in the activity of urticaria over a 4 week period.
Psychological Measures (Composite)
Effects of brief behavioral activation intervention based upon psychological differences including depression and anxiety measured over a 4 week period.
Full Information
NCT ID
NCT02382562
First Posted
March 2, 2015
Last Updated
April 17, 2018
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02382562
Brief Title
Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
Official Title
Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Asthma, Urticaria
Keywords
Depression, Asthma, Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Behavioral Activation Intervention
Arm Type
Experimental
Arm Description
All eligible participants will undergo the Brief Behavioral Activation Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Activation Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control Test
Description
Changes in asthma control over a 4 week period.
Time Frame
4 weeks
Title
Urticaria Control Test
Description
Changes in urticaria control over a 4 week period.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire
Description
Changes in asthma quality of life over a 4 week period.
Time Frame
4 weeks
Title
Urticaria Activity Score Questionnaire
Description
Changes in the activity of urticaria over a 4 week period.
Time Frame
4 weeks
Title
Psychological Measures (Composite)
Description
Effects of brief behavioral activation intervention based upon psychological differences including depression and anxiety measured over a 4 week period.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Immune biomarkers
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gailen D Marshall, Jr., MD, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
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