ITAP-VA for Bipolar and Substance Use Disorders
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
12567How 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.
12689Eligibility 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Treatment Adherence Program for Veterans (ITAP-VA)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:
Providence VA Medical Center, Providence, RIProvidence, RI
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
Providence VA Medical CenterCollaborator
References
Adjunctive psychosocial intervention following Hospital discharge for Patients with bipolar disorder and comorbid substance use: A pilot randomized controlled trial. [2018]Bipolar disorder and substance use disorders are highly debilitating conditions, and especially when co-occurring, are associated with a variety of negative outcomes. Surprisingly, there is a relative lack of research on feasible and effective psychosocial treatments for individuals with comorbid bipolar and substance use disorder (BD-SUD), and a dearth of literature examining interventions designed specifically to improve outcomes such as symptoms, functioning, and treatment engagement/adherence following psychiatric hospitalization in this population. In the current paper, we report results of a pilot randomized controlled trial (n=30), comparing the recently developed Integrated Treatment Adherence Program, which includes individual and telephone sessions provided to patients and their significant others, versus Enhanced Assessment and Monitoring for those with BD-SUD. Participants who received the Integrated Treatment Adherence Program demonstrated significantly faster and greater improvements in depression, mania, functioning, and values-consistent living than participants randomized to Enhanced Assessment and Monitoring, and there was a trend for increased treatment adherence over time. Results are discussed in light of existing literature and study limitations, and suggestions for future research are proposed.
Medication adherence and attitudes in patients with bipolar disorder and current versus past substance use disorder. [2022]We examined the impact of substance use disorder (SUD) history among patients with bipolar I disorder (BD) in regards to medication-taking behaviors and attitudes. Interviews were conducted with inpatients hospitalized for BD, which included diagnostic instruments and measures of attitudes concerning psychiatric medications. We compared patients with BD and no history of SUD (BD-NH), BD and past history of SUD (BD-PH), and BD and current SUD (BD-C). The primary outcome variable was a standardized medication adherence ratio (SMAR) of [medication taken]/[medication prescribed]. Fifty-four patients with a BD diagnosis participated, which included BD-NH (n=26), BD-PH (n=19), and BD-C (n=9). The SMAR was significantly different among the three groups; post-hoc analyses revealed the SMAR was significantly lower among BD-C (M=0.70) compared to BD-NH (M=0.90) and BD-PH (M=0.97) patients. This finding remained significant after controlling for numerous patient characteristics. Attitudes regarding medications, measured by the Drug Attitude Inventory (DAI), were positive among a significantly higher percentage of BD-PH (89.47%) and BD-NH (65.38%) compared to BD-C (44.44%) patients. In conclusion, patients with BD-C demonstrated poor medication adherence and attitudes concerning medication management. Helping patients with BD achieve remission from SUD may lead to a more successful course of BD pharmacotherapy.
Therapeutic alliance perceptions and medication adherence in patients with bipolar disorder. [2022]Despite the dissemination of practice guidelines for bipolar disorder, outcomes remain suboptimal, largely due to poor treatment adherence. The episodic nature of bipolar disorder disrupts appropriate patient-provider dynamics, interfering with appropriate care. Maintaining a beneficial therapeutic alliance with providers is one important strategy for improving adherence. We examine the association between adherence and therapeutic environment perceptions among veterans with bipolar disorder.
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]Label="OBJECTIVES">The Veterans Affairs (VA) healthcare system is one of the main providers of substance use treatment within the United States, and many veterans with a substance use disorder (SUD) present with co-occurring diagnoses or other concerns. Though there has been increasing recognition of the need for integration of treatments for SUD and comorbid mental illness, there have been limited studies of such programs, particularly within the VA healthcare system. To address that gap in the literature, this paper examines treatment outcomes in an integrated model of dual diagnosis residential treatment for veterans: the Individualized Addictions Consultation Team (I-ACT) program. Methods: The current paper draws from clinical outcome evaluation data within a residential treatment program at a large Midwestern VA Medical Center (VAMC). The I-ACT program provides residential substance abuse treatment to individuals with a primary SUD and other factors that interfere with the successful completion of a traditional residential rehabilitation program. Between 2017 and 2018, 130 individuals (97.7% men, average age = 60.62 years) entered the I-ACT program. As part of standard measurement-based care, veterans were administered the Brief Addiction Monitor and the Patient Health Questionnaire-9 at admission and discharge. Results: Most individuals (74.6%) who entered I-ACT completed the residential program (average length of stay 34.2 days). Scores on both measures significantly decreased from intake to discharge (p < .001), with the change in depression scores indicating clinically significant improvement. Those with an additional mental health diagnosis achieved similar decreases in substance use symptoms and had lower depression scores at discharge than those with a SUD alone. Conclusions: Our results indicate that even for veterans who may not benefit from traditional SUD treatment programs, a more integrated and personalized residential program can be effective.
Improving treatment adherence in patients with bipolar disorder and substance abuse: rationale and initial development of a novel psychosocial approach. [2021]Patients with comorbid bipolar and substance use disorders are at particularly high risk for treatment nonadherence and a host of negative consequences. However, no previous interventions have been designed specifically to address this problem. In the current study, we describe the rationale for and initial development of an adjunctive psychosocial intervention that targets adherence in patients with bipolar disorder who are substance abusers. The intervention involves brief in-person sessions and follow-up phone contacts with the patient and a significant other/family member. We describe the effects of this novel intervention on adherence and other psychiatric outcomes in a series of cases treated as part of our initial development work. Results suggest that the intervention is feasible and acceptable to patients and could be helpful in enhancing the effects of existing treatments. Given these promising results, we plan to test the intervention further in a randomized clinical trial.
Update on bipolar disorder and substance abuse: recent findings and treatment strategies. [2019]Between 40% and 70% of people with bipolar disorder have a history of substance use disorder. A current or past comorbid substance use disorder may lead to worse outcomes for bipolar disorder, including more symptoms, more suicide attempts, longer episodes, and lower quality of life. Unfortunately, few treatments have been studied in patients with both illnesses, and large controlled trials are needed. Evidence from small studies suggests that some treatments proven for bipolar disorder (e.g., divalproex, lithium, quetiapine, lamotrigine, and psychotherapy) may decrease substance abuse or dependence. Both the bipolar disorder and the substance use disorder should be considered when determining the best management strategy. Once treatment has begun, clinicians should ensure that medication and psychotherapy are administered appropriately and that treatment is modified when there is inadequate response.
Predictors of psychotropic medication adherence among HIV+ individuals living with bipolar disorder. [2018]HIV infection and bipolar disorder are highly comorbid and associated with frontostriatal disruption, emotional dysregulation, and neurocognitive impairment. Psychiatric and cognitive factors have been linked to antiretroviral nonadherence; however, predictors of psychotropic adherence among HIV+ individuals with psychiatric comorbidities have not been explored. We evaluated predictors of psychotropic adherence among individuals with HIV infection and bipolar disorder.
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]Bipolar disorder patients (BP) with comorbid Substance Use Disorder (SUD) may present clinical features that could compromise adherence and response to pharmacological treatment. The purpose of this study was to examine clinical and psychopathological features of BP with and without comorbid SUD in a real-world setting.
Screening for bipolar disorder among outpatients with substance use disorders. [2020]Comorbidity of bipolar disorder and alcohol or substance abuse/dependence is frequent and has marked negative consequences on the course of the illness and treatment compliance. The objective of this study was to compare the validity of two short instruments aimed at screening bipolar disorders among patients treated for substance use disorders.