ITAP-VA for Bipolar and Substance Use Disorders

Overseen By Brandon A Gaudiano, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Psychiatric medications

Disqualifiers: Non-English speakers, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different support programs for Veterans with both bipolar disorder and substance use issues after a hospital stay. One group will participate in the Integrated Treatment Adherence Program for Veterans (ITAP-VA), which includes meetings and phone calls, sometimes involving a loved one, over six months. The other group will receive enhanced check-ups to monitor symptoms and safety during the same period. Participants must have a diagnosed mood disorder, a substance use disorder, and be on at least one psychiatric medication. As an unphased trial, this study provides Veterans an opportunity to contribute to research that could enhance support programs for others in similar situations.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research into the Integrated Treatment Adherence Program for Veterans (ITAP-VA) lacks specific safety data. However, this program focuses on improving mental health and adherence to treatment plans through counseling and support, rather than medication. Such programs are generally easy for participants to handle.

Studies of similar programs have not reported safety issues. Since ITAP-VA involves in-person meetings and phone conversations, it is unlikely to cause physical health problems. Participants typically find these support programs manageable.

Overall, while detailed safety data for ITAP-VA itself is unavailable, similar programs are generally safe and beneficial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Treatment Adherence Program for Veterans (ITAP-VA) because it offers a unique blend of continuous support and involvement from significant others, which isn't common in current treatments for bipolar and substance use disorders. Unlike standard options that often rely heavily on medication and individual therapy, ITAP-VA combines in-person and phone sessions, fostering a more consistent engagement over six months post-hospitalization. This approach aims to enhance adherence to treatment plans and improve long-term outcomes by integrating the support system of the patient, which could lead to better management of symptoms and reduced relapse rates.

What evidence suggests that this trial's treatments could be effective for bipolar and substance use disorders?

Research has shown that the Integrated Treatment Adherence Program for Veterans (ITAP-VA), one of the treatment arms in this trial, helps individuals with bipolar disorder improve symptoms of depression and mania more quickly and effectively. This program emphasizes adherence to the treatment plan, which reduces suicidal thoughts and bipolar symptoms. Treating both substance use and mental health issues together has consistently proven more effective than addressing each separately. This suggests that ITAP-VA could be a promising option for those dealing with both bipolar disorder and substance use. Another treatment arm in this trial, the Safety Assessment and Follow-up Evaluation (SAFE), focuses on enhanced symptom monitoring and safety evaluation. ^{1 2 3 5 6}

Who Is on the Research Team?

Brandon A Gaudiano, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Jane Metrik, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Providence VA Medical Center

Collaborator

Trials

27

Recruited

72,500+

Published Research Related to This Trial

Patients with bipolar I disorder and current substance use disorder (BD-C) showed significantly lower medication adherence compared to those with no history of substance use disorder (BD-NH) and those with a past history (BD-PH), with adherence ratios of 0.70, 0.90, and 0.97 respectively.

Positive attitudes towards medications were notably lower in the BD-C group (44.44%) compared to BD-PH (89.47%) and BD-NH (65.38%), suggesting that addressing substance use issues may improve medication management and treatment outcomes for bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence and attitudes in patients with bipolar disorder and current versus past substance use disorder. Teter, CJ., Falone, AE., Bakaian, AM., et al.[2022]

In a pilot randomized controlled trial involving 30 participants, the Integrated Treatment Adherence Program showed significantly faster and greater improvements in depression, mania, functioning, and values-consistent living compared to the Enhanced Assessment and Monitoring approach for individuals with comorbid bipolar disorder and substance use disorder.

The Integrated Treatment Adherence Program also suggested a trend towards increased treatment adherence over time, highlighting its potential effectiveness in improving engagement and outcomes for this challenging population.

NCBI (Pubmed)

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. Wenze, SJ., Gaudiano, BA., Weinstock, LM., et al.[2018]

A significant number of individuals with bipolar disorder (40% to 70%) also struggle with substance use disorders, which can worsen their bipolar symptoms and overall quality of life.

Some treatments for bipolar disorder, like divalproex, lithium, and psychotherapy, may also help reduce substance abuse, highlighting the need for integrated treatment strategies that address both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on bipolar disorder and substance abuse: recent findings and treatment strategies. Ostacher, MJ., Sachs, GS.[2019]

Patients with bipolar disorder (BP) who also have a comorbid substance use disorder (SUD) tend to have poorer social functioning compared to those without SUD, indicating a significant impact on their daily lives and treatment adherence.

Interestingly, those with BP and SUD are less likely to be diagnosed with Bipolar Disorder I and show less severe manic symptoms, suggesting that the presence of SUD may influence the clinical presentation of bipolar disorder.

NCBI (Pubmed)

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. Mazza, M., Mandelli, L., Di Nicola, M., et al.[2013]

In a study of 50 individuals with HIV and bipolar disorder, the average adherence to psychiatric medications was 78%, with 56% achieving over 90% adherence, indicating a significant challenge in medication compliance in this population.

Factors such as current depressive symptoms, negative attitudes toward medications, and neurocognitive impairments were found to significantly predict poorer adherence, suggesting that addressing these issues could improve medication compliance among HIV+ individuals with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of psychotropic medication adherence among HIV+ individuals living with bipolar disorder. Casaletto, KB., Kwan, S., Montoya, JL., et al.[2018]

A new psychosocial intervention has been developed specifically for patients with bipolar disorder and substance use disorders to improve treatment adherence, which is crucial for their recovery.

Initial results from case studies indicate that this intervention is feasible and acceptable to patients, showing potential to enhance existing treatments, leading to plans for further testing in a randomized clinical trial.

NCBI (Pubmed)

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. Gaudiano, BA., Weinstock, LM., Miller, IW.[2021]

The Individualized Addictions Consultation Team (I-ACT) program at a Midwestern VA Medical Center successfully treated 130 veterans with substance use disorders (SUD) and co-occurring mental health issues, with 74.6% completing the program over an average stay of 34.2 days.

Participants showed significant improvements in both substance use and depression symptoms from admission to discharge, indicating that integrated treatment approaches can be effective for veterans who struggle with traditional rehabilitation methods.

NCBI (Pubmed)

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. Keating, S., Larsen, SE., Collingwood, J., et al.[2021]

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]

The study evaluated the Mood Disorder Questionnaire (MDQ) and the Hypomania Checklist-32 (HCL-32) for screening bipolar disorder in 152 patients with substance use disorders, finding that the HCL-32 was more sensitive (90.9%) while the MDQ was more specific (77.3%).

Both screening tools showed limitations, with a positive predictive value under 50%, indicating that caution is necessary when using them for diagnosing bipolar disorder in patients with substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for bipolar disorder among outpatients with substance use disorders. Nallet, A., Weber, B., Favre, S., et al.[2020]

Citations

1. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707369

IIR 19-048 – HSR Study - VA Health Systems Research ITAP is an innovative psychosocial intervention developed by our team designed to improve treatment adherence and reduce suicidality, bipolar symptoms, and ...

2. withpower.com withpower.com/trial/phase-disease-10-2020-d96d5

ITAP-VA for 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04127604

Post-Hospital Intervention for Veterans With Comorbid ... This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric ...

4. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=1282

VA's Telehealth Program for Bipolar Disorders Is Associated ... FINDINGS: Veterans who completed the BDTH program reported reductions in manic (17%) and depressive (29%) symptoms, and a reduction in mood episodes (21 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3753025/

Integrated Treatment of Substance Use and Psychiatric ... Integrated treatment for comorbidity has been found to be consistently superior compared to treatment of individual disorders with separate treatment plans.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3071706/

Improving Treatment Adherence in Patients with Bipolar ... Patients with comorbid bipolar and substance use disorders are at particularly high risk for treatment nonadherence and a host of negative consequences.