Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Senyo Health App

    Other intervention

    The 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

40 Participants
are divided into 1 treatment group
Group A: Senyo Health appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
2

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.

Time frame
Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
3

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.

Time frame
Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
4

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.

Time frame
Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months

Other outcomes

Sponsors and contacts

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