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ITAP-VA for Bipolar and Substance Use Disorders

Led By Jane Metrik, 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
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 below
I have been diagnosed with a mood disorder.
I am currently taking medication for a mental health condition.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

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
1,609 Previous Clinical Trials
3,306,464 Total Patients Enrolled
17 Trials studying Bipolar Disorder
2,446 Patients Enrolled for Bipolar Disorder
Jane Metrik, PhDPrincipal InvestigatorProvidence VA Medical Center, Providence, RI
2 Previous Clinical Trials
481 Total Patients Enrolled

Media Library

Integrated Treatment Adherence Program for Veterans (ITAP-VA) Clinical Trial Eligibility Overview. Trial Name: NCT04127604 — N/A

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
~23 spots leftby Jan 2025