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

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment ITAP + SAFE for Bipolar and Substance Use Disorders?

A pilot study showed that the Integrated Treatment Adherence Program (ITAP) led to faster and greater improvements in mood and daily functioning for patients with both bipolar disorder and substance use disorder, compared to standard monitoring. This suggests that ITAP may help improve treatment outcomes for these patients. ^{1 2 3 4 5}

What makes the ITAP + SAFE treatment unique for bipolar and substance use disorders?

The ITAP + SAFE treatment is unique because it combines a psychosocial approach with brief in-person sessions and follow-up phone contacts involving the patient and a family member, specifically targeting treatment adherence in patients with both bipolar disorder and substance use disorders. This approach is novel as it directly addresses the high risk of treatment nonadherence in this population, which has not been specifically targeted by previous interventions. ^{2 4 5 6 7}

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.

Research Team

Brandon Gaudiano, PhD

Principal Investigator

Butler Hospital

Ivan Miller, PhD

Principal Investigator

Butler Hospital

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.

You have a problem with drugs or alcohol addiction.

Exclusion Criteria

Unable to speak and read English

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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

Does recovery from substance use disorder matter in patients with bipolar disorder? [2022]

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

Medication compliance among patients with bipolar disorder and substance use disorder. [2022]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Preventive Medication Patterns in Bipolar Disorder and Their Relationship With Comorbid Substance Use Disorders in a Cross-National Observational Study. [2022]

7. 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]