NCT02382562

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2016

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

March 2, 2015

Last Update Submit

April 17, 2018

Conditions

Keywords

DepressionAsthmaUrticaria

Outcome Measures

Primary Outcomes (2)

  • Asthma Control Test

    Changes in asthma control over a 4 week period.

    4 weeks

  • Urticaria Control Test

    Changes in urticaria control over a 4 week period.

    4 weeks

Secondary Outcomes (3)

  • Asthma Quality of Life Questionnaire

    4 weeks

  • Urticaria Activity Score Questionnaire

    4 weeks

  • Psychological Measures (Composite)

    4 weeks

Other Outcomes (1)

  • Immune biomarkers

    4 weeks

Study Arms (1)

Brief Behavioral Activation Intervention

EXPERIMENTAL

All eligible participants will undergo the Brief Behavioral Activation Intervention.

Behavioral: Brief Behavioral Activation Intervention

Interventions

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.

Brief Behavioral Activation Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

DepressionAsthmaUrticaria

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gailen D Marshall, Jr., MD, PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gailen D. Marshall, Jr., MD, PhD

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

October 17, 2016

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations