ITAP + SAFE for Bipolar and Substance Use Disorders

(ITAP Trial)

Overseen By Brandon Gaudiano, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Must be taking: Mood stabilizers

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 explores new ways to help individuals with both bipolar disorder and substance use issues. Participants will join either the Integrated Treatment Adherence Program (ITAP), which focuses on adherence to treatment plans, or the Safety Assessment and Follow-up Evaluation (SAFE), which includes enhanced safety checks, both alongside regular care. The trial aims to determine which approach better supports recovery after a hospital stay. It is suitable for those diagnosed with bipolar disorder and a substance use problem who are taking at least one mood-stabilizing medication. As an unphased trial, it offers a unique opportunity to contribute to innovative treatment strategies that could improve recovery outcomes.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on at least one mood-stabilizing medication. It seems likely you can continue your current medications.

What prior data suggests that these interventions are safe for patients with bipolar and substance use disorders?

Research has shown that programs like the Integrated Treatment Adherence Program (ITAP) are generally well-received by individuals with bipolar disorder and substance use issues. These programs combine therapy sessions with support from family and friends to help participants adhere to their treatment plans. Although studies don't list specific side effects, these programs are usually considered safe because they don't involve medication.

Similarly, the Safety Assessment and Follow-up Evaluation (SAFE) program focuses on closely monitoring symptoms and ensuring safety after patients leave the hospital. Like ITAP, SAFE doesn't involve medications, which typically results in fewer side effects.

Both ITAP and SAFE aim to help individuals manage their conditions by providing behavioral support rather than medical treatment. This generally makes them safer options with a very low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Treatment Adherence Program (ITAP) and the Safety Assessment and Follow-up Evaluation (SAFE) because they offer a fresh approach to managing bipolar and substance use disorders. Unlike standard treatments that often focus solely on medication, ITAP emphasizes a combination of in-person and phone sessions, along with involving the patient's significant other, lending a more supportive and comprehensive approach to care. SAFE, on the other hand, enhances symptom monitoring and safety evaluation, potentially leading to better long-term outcomes by actively tracking patient progress over six months post-hospitalization. These strategies aim to improve adherence and safety, which are crucial in tackling the complexities of these disorders.

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

In this trial, participants will join one of two treatment arms. The Integrated Treatment Adherence Program (ITAP), which some participants will receive, has quickly and significantly improved symptoms for people with bipolar disorder and substance use issues, as studies have shown. Research indicates that ITAP helps reduce substance abuse and mood swings, though it doesn't always enhance adherence to treatments. Meanwhile, the Safety Assessment and Follow-up Evaluation (SAFE), another treatment option in this trial, involves extra safety checks and regular symptom monitoring. Research suggests these measures are helpful for those with both mental health and substance use problems. Both ITAP and SAFE aim to support recovery by focusing on personalized care and regular follow-up, addressing mental health and substance use issues together, which is crucial for effective treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Brandon Gaudiano, PhD

Principal Investigator

Butler Hospital

Ivan Miller, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

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.

You have a problem with drugs or alcohol addiction.

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 a specialized psychosocial intervention program or an enhanced safety monitoring program 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

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Integrated Treatment Adherence Program (ITAP) 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?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

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

ITAP-VA for Bipolar and Substance Use Disorders In a pilot randomized controlled trial involving 30 participants, the Integrated Treatment Adherence Program showed significantly faster and greater ...

2. library.samhsa.gov library.samhsa.gov/sites/default/files/ebp-kit-building-your-program-10112019.pdf

Integrated Treatment for Co-Occurring Disorders They are trained in skills that have been found to be effective in treating consumers with co-occurring disorders. Up to 56 percent of people with the most.

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

Improving Treatment Adherence in Patients with Bipolar ... Results showed trends favoring the integrated group in terms of improvements in substance abuse and mood episodes. Again, no differences in treatment adherence ...

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

Integrated Treatment of Substance Use and Psychiatric ... This article focuses on a review of the risks for developing comorbid disorders and the combinations of treatments that appear to be most effective for clients ...

5. 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 ...