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Active intervention for Emotional Distress

Phase 2
Waitlist Available
Research Sponsored by Memorial Hermann Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks from baseline.
Awards & highlights

Study Summary

This trial is testing whether tracking emotional distress can help lower levels of it. People with TBI rate their levels of emotional distress several times a week, and the hope is that this will help lower emotional distress or prevent it from developing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks from baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks from baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Personal Health Questionnaire - 9 (PHQ-9) and Global Anxiety Disorder - 7 (GAD-7) scores combined.

Trial Design

2Treatment groups
Active Control
Group I: Wait listActive Control1 Intervention
Wait list participants have no study activities for 6 weeks after completing the baseline assessment. After 6 weeks, list participants complete the 6 week assessment. After completing the assessment. wait list participants are trained to use the mood tracker app and instructed to complete multiple self-ratings each week. Each the participant receives a support call each week for 6 weeks to engage the participant in the study and to address any problems the participant may have in completing self ratings. After 6 weeks of self-ratings, the participant complete the 12 week outcome and the participant's involvement with the study ends.
Group II: Active interventionActive Control1 Intervention
Participants assigned to the active treatment arm are trained to use the mood tracker app and instructed to complete multiple self-ratings each week. Each the participant receives a support call each week for 6 weeks to engage the participant in the study and to address any problems the participant may have in completing self ratings. After 6 weeks of self-ratings, the participant complete the 6 week outcome. The participant is encouraged to continue completing the self-ratings, but does not receive any more support calls. After 6 more weeks, the 12 week outcome is assessed the participant's involvement with the study ends.

Find a Location

Who is running the clinical trial?

TIRR Memorial HermannOTHER
15 Previous Clinical Trials
4,629 Total Patients Enrolled
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,826 Total Patients Enrolled
2 Trials studying Emotional Distress
820 Patients Enrolled for Emotional Distress
Memorial Hermann Health SystemLead Sponsor
8 Previous Clinical Trials
2,001,691 Total Patients Enrolled
1 Trials studying Emotional Distress
19 Patients Enrolled for Emotional Distress

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
Memorial Hermann Hospital-Texas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Mood Tracker Smartphone App for Management of Emotional Distress After TBI
2019. "Mood Tracker Smartphone App for Management of Emotional Distress After TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410770.
All > Tb
~21 spots leftby Apr 2025
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