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ITAP-VA for Bipolar and Substance Use Disorders

N/A
Recruiting
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
Must not have
Younger than age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

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
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I have been diagnosed with a mood disorder.
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I am currently taking medication for a mental health condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.

Timeline

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium, divalproex), antipsychotics (e.g., risperidone, quetiapine), and psychosocial interventions. Mood stabilizers work by balancing neurotransmitter levels, reducing the frequency and severity of mood swings. Antipsychotics help manage symptoms of mania and psychosis by blocking dopamine receptors. Psychosocial interventions, such as cognitive-behavioral therapy (CBT), focus on modifying negative thought patterns and behaviors, improving coping strategies, and enhancing medication adherence. These treatments are crucial for Bipolar Disorder patients as they address both the biological and psychological aspects of the disorder, leading to more comprehensive and effective management.

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
1,628 Previous Clinical Trials
3,325,839 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
~14 spots leftby Jan 2025
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