Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04526067
Other study ID # HSC20200525H
Secondary ID 1R56MH123797
Status Completed
Phase N/A
First received
Last updated
Start date November 24, 2020
Est. completion date November 11, 2022

Study information

Verified date June 2023
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date November 11, 2022
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
United States University of Texas Health Science Center - Department of Psychiatry San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptance of intervention Proportion of subjects who dropped out of treatment Baseline to 6 months
Primary Medication Adherence Adherence percent is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period X100. Monthly checks will be performed. Baseline to 6 months
Secondary Cost of treatment Cost to include mail, supports, provider time in visit, preparation time and mileage Baseline to 6 months
Secondary Pill count percent Medication possession ratio from prescription refill data Baseline to 6 months
Secondary Self-Report Habit Index (SRHI) A 12-item scale assessing three proposed characteristics of habit;1) automaticity , 2) frequency, and 3) relevance to self-identity. Four items of this scale, items 2,3,5 and 8 represent the Self-Reported Behavioral Automaticity Index (SRBAI). Lower scores indicate greater habit strength and greater automaticity. A mean Habit score will be computed using the entire scale. Baseline and at month 2, 4 and 6
Secondary Symptomatology Change in symptoms assess by a trained rater using the Brief Psychiatric Rating Scale-Expanded Version (BPRS-E). The scale is used to rate the subjects using 24 items, each to be rated in a 7-point scale of severity ranging from NA (not assessed), then 1-7, with 7 being the most severe. A total score reflects an overall level of symptomology, with 164, being the maximum score, with the most symptoms present. Baseline and at month 2, 4 and 6
Secondary Functional Outcome Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).70 The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. Baseline and month 2, 4 and 6
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A