Depressive Disorder, MajorR-CATNCT04526067
In-person vs. Remote Wellness Support
A study testing CAT and R-CAT in people with Depressive Disorder, Major and Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major, Bipolar Disorder, Schizo Affective Disorder
- What is being tested?
- CAT and R-CAT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 11 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, 78229
About this study
Official title: In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))
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.
Read the 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.
- Being tested
- CAT, R-CAT
- Keywords
- Serious mental illness
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATBehavioural
Also called Cognitive Adaptation Training
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-CATBehavioural
Also called Remote Cognitive Adaptation Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Adaptation Training (CAT) | Active comparator | A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions. Receives: Behavioral: CAT |
| Remote Cognitive Adaptation Training (R-CAT) | Active comparator | A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions. Receives: Behavioral: R-CAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment
Proportion of subjects who dropped out of treatment
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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>
Measured: Baseline to 6 months note that repeated measures analysis was also used
Secondary outcomes (2)
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.
Measured: Baseline to 6 months (note that repeated measures analysis examined change over time as well.
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start24 Nov 2020
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dawn Velligan, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526067
- Sponsor's protocol ID
- HSC20200525H
- Other IDs
- 1R56MH123797
- Acronym
- R-CAT
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2020
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because this is a research study, we will be unable keep your PHI completely confidential. We may share your health information with people and groups involved in overseeing this research study including: * The National Institute of Mental Health who is funding this study * The following collaborators at other institutions that are involved with the study: Superior Medicaid * The committee that checks the study data on an ongoing basis, to determine if the study should be stopped for any reason. * The members of the local research team * The Institutional Review Board and the Compliance Office of the University of Texas Health Science Center at San Antonio, and other groups that oversee how research studies are carried out.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))
- ClinicalTrials.gov ID
- NCT04526067
- Acronym / sponsor ID
- R-CAT / HSC20200525H
- Keywords
- Serious mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel design
| Arm | Type | Receives |
|---|---|---|
| Cognitive Adaptation Training (CAT) | Active comparator | Behavioral: CATA home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions. |
| Remote Cognitive Adaptation Training (R-CAT) | Active comparator | Behavioral: R-CATA primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATAlso: Cognitive Adaptation TrainingAn 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. | Behavioural | Cognitive Adaptation Training (CAT) |
| R-CATAlso: Remote Cognitive Adaptation TrainingAn 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. | Behavioural | Remote Cognitive Adaptation Training (R-CAT) |
Primary outcome
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment
Time frame: Baseline to 6 months
Proportion of subjects who dropped out of treatment
Medication Adherence
Time frame: 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
Time frame: 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>
2 secondary outcomes
Self-Report Habit Index (SRHI)
Time frame: Baseline to 6 months (note that repeated measures analysis examined change over time as well.
Symptomatology
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Because this is a research study, we will be unable keep your PHI completely confidential. We may share your health information with people and groups involved in overseeing this research study including: * The National Institute of Mental Health who is funding this study * The following collaborators at other institutions that are involved with the study: Superior Medicaid * The committee that checks the study data on an ongoing basis, to determine if the study should be stopped for any reason. * The members of the local research team * The Institutional Review Board and the Compliance Office of the University of Texas Health Science Center at San Antonio, and other groups that oversee how research studies are carried out.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Velligan, PhD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAT and R-CAT in people with Depressive Disorder, Major and Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.