ITAP-VA for Bipolar and Substance Use Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Brandon A Gaudiano, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must be taking: Psychiatric medications

Disqualifiers: Non-English speakers, Under 18

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a special program and extra safety checks for Veterans with bipolar disorder and substance use issues. The goal is to help them stick to their treatment plans and ensure their safety after leaving the hospital.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it mentions that participants must be taking at least one psychiatric medication. This suggests you may continue your current medications.

What data supports the effectiveness of the ITAP-VA treatment for veterans with bipolar and substance use disorders?

Research shows that the Integrated Treatment Adherence Program, which is part of ITAP-VA, led to faster and greater improvements in depression, mania, and overall functioning for patients with both bipolar disorder and substance use issues. Additionally, a similar integrated treatment program for veterans with complex substance use disorders showed significant improvements in depression and substance use symptoms, suggesting that integrated approaches can be effective. ^{1 2 3 4 5}

Is the Integrated Treatment Adherence Program for Veterans (ITAP-VA) safe for humans?

The available research does not provide specific safety data for the Integrated Treatment Adherence Program for Veterans (ITAP-VA), but it suggests that the program is feasible and acceptable to patients, which implies it is generally safe for human use. ^{1 2 5 6 7}

How is the ITAP-VA treatment different from other treatments for bipolar and substance use disorders?

The ITAP-VA treatment is unique because it combines individual and telephone sessions for patients and their significant others, focusing on improving treatment adherence and outcomes like depression, mania, and functioning, which is not commonly addressed in standard treatments for bipolar and substance use disorders. ^{1 2 6 8 9}

Research Team

Jane Metrik, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Brandon A Gaudiano, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Eligibility Criteria

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.

Inclusion Criteria

Diagnosis of a substance use disorder (drug and/or alcohol)

I have been diagnosed with a mood disorder.

I am currently taking medication for a mental health condition.

Exclusion Criteria

Unable to speak and read English

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Integrated Treatment Adherence Program for Veterans (ITAP-VA) or the Safety Assessment and Follow-up Evaluation (SAFE) over 6 months post-hospitalization

6 months

Combination of in-person and phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Integrated Treatment Adherence Program for Veterans (ITAP-VA) (Behavioral Intervention)
• Safety Assessment and Follow-up Evaluation (SAFE) (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Integrated Treatment Adherence Program for Veterans (ITAP-VA) Experimental Treatment 1 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 Control 1 Intervention

Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Providence VA Medical Center

Collaborator

Trials

27

Recruited

72,500+

Findings from Research

A study involving 435 veterans with bipolar disorder found that a positive therapeutic alliance with healthcare providers significantly improves medication adherence, with effect sizes ranging from 13% to 20%.

Veterans who felt their providers encouraged regular communication and progress reviews were more likely to adhere to their medication regimens, highlighting the importance of strong patient-provider relationships in managing bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic alliance perceptions and medication adherence in patients with bipolar disorder. Zeber, JE., Copeland, LA., Good, CB., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Adjunctive psychosocial intervention following Hospital discharge for Patients with bipolar disorder and comorbid substance use: A pilot randomized controlled trial. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Medication adherence and attitudes in patients with bipolar disorder and current versus past substance use disorder. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic alliance perceptions and medication adherence in patients with bipolar disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Individualized Addictions Consultation Team Residential Program: A Creative Solution for Integrating Care for Veterans With Substance Use Disorders Too Complex for Other Residential Treatment Programs. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Improving treatment adherence in patients with bipolar disorder and substance abuse: rationale and initial development of a novel psychosocial approach. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Update on bipolar disorder and substance abuse: recent findings and treatment strategies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Predictors of psychotropic medication adherence among HIV+ individuals living with bipolar disorder. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical features, response to treatment and functional outcome of bipolar disorder patients with and without co-occurring substance use disorder: 1-year follow-up. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Screening for bipolar disorder among outpatients with substance use disorders. [2020]