About this trial
The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving alcohol use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>=18 years;
History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type. Can be clinical diagnosis
Ability to read, write, and understand English;
Minimum DAST (1+) or AUDIT-C score (3+)
Disqualifiers
Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment;
Needing a higher level of mental health care as demonstrated by ASAM[36] assessment; - completed by LADC or MD investigators
Already admitted into or about to initiate treatment in another addiction treatment program.
Currently attending High School. (can be 18 though)
Trial design
Single group
Treatments tested in this trial
Senyo Health App
Other interventionThe Senyo Health app includes asynchronous cognitive behavioral therapy (CBT) modules, contingency management, behavioral activation, and an interface to interact with the care manager for support in treating the comorbidities of bipolar disorder and substance use disorder. Patients will engage with the app daily and have weekly check-in visits with the care manager. After the initial 12 week intervention phase, subjects will be followed for 1 year.
Treatment groups
Trial outcomes
Primary outcomes
System Usability Scale (SUS) score
The System Usability Scale (SUS) is a 10-item scale to assess usability of the app. Statements are rated on a 5 point scale where 1 = 'strongly disagree' and 5 = 'strongly agree'. Higher total scores indicates higher perception of app usability by patients.
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) is a 12 question survey that assesses acceptability, appropriateness, and feasibility of the app. Responses are on a 5 point scale where 1 = 'completely disagree' and 5 = 'completely agree'. Higher scores indicate greater acceptance of the app.
Intervention Appropriatness Measure
The Intervention Appropriateness Measure (IAM) is a tool consisting of 4 items designed to assess the suitability and relevance of an intervention without specifying a particular purpose, person, or situation. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs.
Feasibility of Intervention Measure
Measuring the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting.
Secondary outcomes
Change in Brief Substance Craving Scale (BSCS) score
The Brief Substance Craving Scale (BSCS) survey assesses the intensity, frequency, number of times, and length of time a subject craves a substance over a 24 hour period. The statements are rated on a 5 point scale, where 0 = 'never/none' and 4 = 'extreme/constant'. Higher overall scores indicates a greater deal of craving for substances of abuse.
Change in Generalized Anxiety Disorder-7 (GAD-7) score
The General Anxiety Disorder is a 7-item scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of 'not at all', 'several days', 'more than half the days', and 'nearly every day'. Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Change in Patient Health Questionnaire-9 (PHQ-9) score
The Patient Health Questionnaire 9-item (PHQ-9) scale is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of 'not at all', 'several days', 'more than half the days', and 'nearly every day'. Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Change in Patient Mania Questionnaire-9 (PMQ-9) score
The Patient Mania Questionnaire-9 (PMQ-9) questionnaire is a 9 item scale to assess symptoms of mania. Statements are rated on a 4 point scale where 0 = 'not at all' and 3 = 'nearly every day'. Higher overall scores indicate a greater presence of mania type symptoms.
Sponsors and contacts
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