N/A
N=56
In-person vs. Remote Wellness Support
Depressive Disorder, Major · Bipolar Disorder · Schizo Affective Disorder · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT04526067 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAT (Behavioral); R-CAT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment |
4; 3 | — |
| PRIMARY Medication Adherence |
.21; .10 | — |
| PRIMARY Functional Outcome |
1.88; 6.48 | — |
| SECONDARY Self-Report Habit Index (SRHI) |
6.6; 7.6 | — |
| SECONDARY Symptomatology |
13.7; 6.82 | — |
Summary
The study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.
Eligibility Criteria
Inclusion Criteria
- Able to give informed consent.
- Between the ages of 18 and 65.
- Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
- Receiving treatment with oral psychiatric medications.
- Have had a hospitalization or emergency department visit in the past year
- Have a Medication Possession Ratio (MPR) based upon electronic refill data below 80% at least 1 of the past 4 quarters with at least 1 psychiatric medication
- Responsible for taking their own medications
- Report on telephone prescreen call with researcher team that they have missed at least 2 doses of medication in the past 3 weeks, that they are willing to take medication and would like remote assistance to take medication more regularly
- Report on telephone prescreen call with research team that they have a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year
- Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
- Have a working smart phone
- Able to understand and complete rating scales and assessments.
- Agree to home visits for intervention and to count pills and conduct assessments
Exclusion Criteria
- Substance dependence within the past 2 months
- Currently being treated by an ACT team
- Documented history of violence or threatening behavior on initial assessment
- Receive home visits to assist with medication adherence
- Unable to complete baseline assessments
Data sourced from ClinicalTrials.gov (NCT04526067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.