Depressive Disorder, Major, Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
Conditions
Keywords
Serious mental illness
Brief 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.
Detailed 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.
Interventions
BEHAVIORALCAT
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.
BEHAVIORALR-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.
Sponsors
National Institute of Mental Health (NIMH)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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.
Intervention model description
Randomized parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment | Baseline to 6 months | Proportion of subjects who dropped out of treatment |
| Medication Adherence | Baseline to 6 months | Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed. |
| Functional Outcome | Baseline to 6 months note that repeated measures analysis was also used | Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).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. The value reported is the the 6 month value minus the baseline value\> |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report Habit Index (SRHI) | Baseline to 6 months (note that repeated measures analysis examined change over time as well. | A 36-item scale assessing three types of habit taking medication, following a schedule or calendar, and grooming (specifically brushing teeth. 12 items assessed each behavior; The SRHI looks at 1) automaticity , 2) frequency, and 3) relevance to self-identity for each behavior. There are 12 items for each sub-scale scored 1-7 (total possible range is 12-84 for each of the 3 scales). A total Habit score will be computed by calculating the mean of the 3 sub-scales to give a value between 12 and 84. Lower mean scores indicate greater habit strength. |
| Symptomatology | Baseline to 6 months | 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. The possible range of scores is from 1 to 168 with a total score reflects an overall level of symptomology, with 168, being the maximum score, with the most symptoms present. The value reported is the 6 month value minus the baseline value. |
Countries
United States
Participant flow
Recruitment details
Participants were 56 members of a large Managed Medicaid program in Texas
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Adaptation Training (CAT) A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
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. | 21 |
| Remote Cognitive Adaptation Training (R-CAT) A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
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. | 35 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cognitive Adaptation Training (CAT) | Total | Remote Cognitive Adaptation Training (R-CAT) |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 14 | 44.9 years STANDARD_DEVIATION 11.9 | 44.8 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 13 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 39 Participants | 26 Participants |
| Social and Occupational Functioning Scale score | 39.1 units on a scale STANDARD_DEVIATION 2.4 | 42.72 units on a scale STANDARD_DEVIATION 2.09 | 44.9 units on a scale STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 21 |
| other Total, other adverse events | 0 / 35 | 0 / 21 |
| serious Total, serious adverse events | 0 / 35 | 0 / 21 |
Outcome results
Primary
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment
Proportion of subjects who dropped out of treatment
Time frame: Baseline to 6 months
Population: examined descriptive statistics for proportion of drop outs by group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| R-CAT | Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment | 4 Participants |
| CAT Cognitive Adaptation Training | Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment | 3 Participants |
Primary
Functional Outcome
Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).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. The value reported is the the 6 month value minus the baseline value\>
Time frame: Baseline to 6 months note that repeated measures analysis was also used
Population: ITT population with at least a baseline and one follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| R-CAT | Functional Outcome | 1.88 score on a scale | Standard Deviation 1.72 |
| CAT Cognitive Adaptation Training | Functional Outcome | 6.48 score on a scale | Standard Deviation 2.08 |
Primary
Medication Adherence
Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed.
Time frame: Baseline to 6 months
Population: IIT population with baseline and at least 1 follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| R-CAT | Medication Adherence | .21 proportion of pills taken | Standard Error 0.05 |
| CAT Cognitive Adaptation Training | Medication Adherence | .10 proportion of pills taken | Standard Error 0.08 |
Secondary
Self-Report Habit Index (SRHI)
A 36-item scale assessing three types of habit taking medication, following a schedule or calendar, and grooming (specifically brushing teeth. 12 items assessed each behavior; The SRHI looks at 1) automaticity , 2) frequency, and 3) relevance to self-identity for each behavior. There are 12 items for each sub-scale scored 1-7 (total possible range is 12-84 for each of the 3 scales). A total Habit score will be computed by calculating the mean of the 3 sub-scales to give a value between 12 and 84. Lower mean scores indicate greater habit strength.
Time frame: Baseline to 6 months (note that repeated measures analysis examined change over time as well.
Population: IIT analysis of all with baseline and at least 1 follow up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| R-CAT | Self-Report Habit Index (SRHI) | 6.6 score on a scale | Standard Deviation 2.69 |
| CAT Cognitive Adaptation Training | Self-Report Habit Index (SRHI) | 7.6 score on a scale | Standard Deviation 3.27 |
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. The possible range of scores is from 1 to 168 with a total score reflects an overall level of symptomology, with 168, being the maximum score, with the most symptoms present. The value reported is the 6 month value minus the baseline value.
Time frame: Baseline to 6 months
Population: ITT sample with baseline and at least one follow up. Also conducted repeated measures analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| R-CAT | Symptomatology | 13.7 score on a scale | Standard Deviation 2.5 |
| CAT Cognitive Adaptation Training | Symptomatology | 6.82 score on a scale | Standard Deviation 2.03 |