Purpose

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.

Category

IRB Number
20200525HU
NCT Number
NCT04526067
Open to Enrollment
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Feiyu Li
lif4@uthscsa.edu

Principal Investigator
Dawn Velligan

Feiyu Li
lif4@uthscsa.edu

Dawn Velligan
(210) 567-5508
velligand@uthscsa.edu



Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. Able to give informed consent.
    2. Between the ages of 18 and 65.
    3. Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
    4. Receiving treatment with oral psychiatric medications.
    5. Have had a hospitalization or emergency department visit in the past year
    6. 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
    7. Responsible for taking their own medications
    8. 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
    9. 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
    10. Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
    11. Have a working smart phone
    12. Able to understand and complete rating scales and assessments.
    13. Agree to home visits for intervention and to count pills and conduct assessments

Exclusion Criteria

    1. Substance dependence within the past 2 months
    2. Currently being treated by an ACT team
    3. Documented history of violence or threatening behavior on initial assessment
    4. Receive home visits to assist with medication adherence
    5. Unable to complete baseline assessments

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized parallel design
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Those with no preference for CAT or R-CAT will be Randomized, 1:1 done by statistician who has no patient contact through a random allocation program. If blinds are broken accidentally, new raters can be assigned, but blinds are kept by having raters and pill counters unaware of treatment group or study design.
Condition
  • Depressive Disorder, Major
  • Bipolar Disorder
  • Schizo Affective Disorder
  • Schizophrenia
  • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Cognitive Adaptation Training (CAT)

    A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
  • Behavioral: CAT

    An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.

    Other names:

    • Cognitive Adaptation Training

  • Active Comparator

    Remote Cognitive Adaptation Training (R-CAT)

    A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
  • Behavioral: R-CAT

    An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.

    Other names:

    • Remote Cognitive Adaptation Training