In-person vs. Remote Wellness Support (R-CAT)

The University of Texas System (UT)

Status: Completed

Conditions: Schizophrenia; Schizo Affective Disorder; Bipolar Disorder; Depressive Disorder, Major

Treatments: Behavioral: CAT; Behavioral: R-CAT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04526067

HSC20200525H

1R56MH123797 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Individuals choosing or assigned to R-CAT will continue treatment as usual with their health care team and R-CAT will be added. R-CAT is a remotely delivered version of CAT focused on medication adherence using a series of manual-driven compensatory strategies and environmental supports (signs, checklists, electronic cueing devices) based upon a streamlined assessment of executive function impairment and barriers to habit formation including forgetfulness, difficulties in problem-solving, disorganization, apathy or amotivation, disinhibition. and home environment. Initial R-CAT goals are to 1) ensure that medications listed as prescribed are available 2) to assess current cognitive, behavioral and environmental facilitators and barriers to habit-formation 3) to set up customized CAT supports to address the barriers and use facilitators to build habits to take medication. Rare home visits may occur if issues cannot be resolved remotely. Based upon the pilot, the study team don't anticipate any more than 5-10% of individuals to need face-to-face visits. No one had home visits as part of the pilot intervention. A structured R-CAT treatment note with places for pictures of CAT interventions is used for home visits. Support and reminder calls use a brief checklist modified from the Healthy Habits Program to address issues in use of supports, placement of supports and habit formation. Examples of CAT interventions to promote taking medication regularly appear above. All home visits and phone calls will be audio-taped (with consent) for quality assurance.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Cognitive Adaptation Training (CAT)

Active Comparator group

Description:

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

Treatment:

Behavioral: CAT

Remote Cognitive Adaptation Training (R-CAT)

Active Comparator group

Description:

A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.

Treatment:

Behavioral: R-CAT