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ITAP-VA for Bipolar and Substance Use Disorders
N/A
Recruiting
Led By Brandon A Gaudiano, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of a mood disorder
Taking at least one psychiatric medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial is testing a new intervention for Veterans with bipolar disorder and substance abuse problems. Half of the participants will receive the new intervention, while the other half will get enhanced safety monitoring.
Who is the study for?
This trial is for Veterans with both bipolar and substance use disorders who are on psychiatric medication. Participants must be able to speak and read English and be 18 years or older.Check my eligibility
What is being tested?
The study tests two programs: ITAP-VA, a psychosocial intervention, versus SAFE, an enhanced safety monitoring program. Both are in addition to routine care, with participants randomly assigned to either group.See study design
What are the potential side effects?
Since the interventions involve psychosocial treatments rather than medications, typical drug side effects aren't expected. However, discussing sensitive topics might cause temporary distress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a mood disorder.
Select...
I am currently taking medication for a mental health condition.
Select...
I am currently taking medication for a mental health condition.
Select...
I have been diagnosed with a mood disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Adherence Rating Scale (BARS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Treatment Adherence Program for Veterans (ITAP-VA)Experimental Treatment1 Intervention
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Group II: Safety Assessment and Follow-up Evaluation (SAFE)Active Control1 Intervention
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Find a Location
Who is running the clinical trial?
Providence VA Medical CenterFED
26 Previous Clinical Trials
72,313 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,865 Total Patients Enrolled
17 Trials studying Bipolar Disorder
2,446 Patients Enrolled for Bipolar Disorder
Brandon A Gaudiano, PhDPrincipal InvestigatorProvidence VA Medical Center, Providence, RI
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a mood disorder.I am under 18 years old.I am currently taking medication for a mental health condition.You have been diagnosed with a drug or alcohol addiction.I am currently taking medication for a mental health condition.I have been diagnosed with a mood disorder.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still in progress?
"Clinicaltrials.gov has reported that this clinical trial is in an open recruitment phase, having been initially posted on November 2nd 2020 and last revised on September 7th 2022."
Answered by AI
What is the current enrollment rate for this medical study?
"Indeed, the details available on clinicaltrials.gov suggest that this medical trial is actively seeking patients. First posted in November 2nd 2020 and last updated in September 7th 2022, the project aims to recruit 140 individuals from a single site."
Answered by AI
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