~14 spots leftby Aug 2025

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

Recruiting in Palo Alto (17 mi)
Gaudiano, Brandon
Overseen ByIvan Miller, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Butler Hospital
No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests two different approaches for helping people with both bipolar disorder and substance use problems. One group gets a special support program with therapy and activities, while the other group gets extra safety check-ins. Both groups continue their usual care.

Eligibility Criteria

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.

Inclusion Criteria

I am currently taking medication to stabilize my mood.
I have been diagnosed with a bipolar disorder.

Exclusion Criteria

I am under 18 years old.

Participant Groups

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.
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 Clinic Near You

Research locations nearbySelect from list below to view details:
Butler HospitalProvidence, RI
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Who is running the clinical trial?

Butler HospitalLead Sponsor
National Institute of Mental Health (NIMH)Collaborator

References