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ITAP + SAFE for Bipolar and Substance Use Disorders (ITAP Trial)

N/A
Waitlist Available
Led By Brandon Gaudiano, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Taking at least one mood-stabilizing medication
Diagnosis of a bipolar-spectrum disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ITAP Trial Summary

This trial is testing a new way to help people with bipolar disorder and addiction. Half the group will get a new program to help them, while the other half will just get closer monitoring.

Who is the study for?
This trial is for adults with both bipolar disorder and a substance use disorder who are on mood-stabilizing medication. Participants must be able to speak and read English. It's not suitable for individuals under the age of 18.Check my eligibility
What is being tested?
The study tests two programs: ITAP, a specialized psychosocial intervention, versus SAFE, an enhanced safety monitoring program. Both are in addition to routine care after psychiatric hospitalization for those with co-occurring disorders.See study design
What are the potential side effects?
Since this trial involves psychosocial interventions rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience stress or discomfort discussing personal issues.

ITAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking medication to stabilize my mood.
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I have been diagnosed with a bipolar disorder.

ITAP Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered Rating Scale for Mania (CARS-M)
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

ITAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Treatment Adherence Program (ITAP)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?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,258 Total Patients Enrolled
4 Trials studying Bipolar Disorder
227 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,688,989 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,425 Patients Enrolled for Bipolar Disorder
Brandon Gaudiano, PhDPrincipal InvestigatorButler Hospital
7 Previous Clinical Trials
353 Total Patients Enrolled
1 Trials studying Bipolar Disorder
180 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

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

How many participants have been enrolled in this research project?

"Affirmative. Clinicaltrials.gov verify that the clinical trial in question, which was posted on October 1st 2020 is currently seeking applicants. The study requires 160 qualified individuals from one site to participate."

Answered by AI

Is this experiment currently looking for more participants?

"Affirmative. Clinicaltrials.gov confirms that since its October 1st, 2020 posting, this clinical trial has been actively searching for new participants. To date, 160 patients have been recruited from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Butler Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Drug and Alcohol use, Bipolar.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Intervention for Comorbid Substance Use and Bipolar Disorders
2020. "Intervention for Comorbid Substance Use and Bipolar Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04202393.
All > Bipolar Disorder
~14 spots leftby Aug 2024
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