Major DepressionNCT02520024
Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living
A study testing self-directed care in people with Major Depression and Bipolar Disorder, run by Temple University Collaborative on Community Inclusion.
Trial summary
This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Bipolar Disorder, Schizophrenia
- What is being tested?
- self-directed care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between 18-65 who are currently receiving Medicaid-reimbursed services in Delaware County, Pennsylvania for either a schizophrenia-spectrum, major depression, or bipolar disorder;
- Individuals with a cost profile within the 60-90% band of all Magellan-administered Medicaid recipients in the county (estimated service costs between $10,048 and $22,324); 3) No more than two inpatient hospitalizations of 10 days per stay, over a 2 year period prior to the study;
- 4) No hospitalization within 6 months of the study; 5) Ability to understand self-directed care requirement and express interest in working with a "recovery coach."
Who cannot join
- do not speak English;
- have a legal guardian;
- are unable to give informed consent
About this study
This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment. The study examined outcomes associated with the implementation of a novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).
- Conditions
- Major Depression, Bipolar Disorder, Schizophrenia
- Being tested
- self-directed care
- Keywords
- self-directed care, serious mental illness
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-directed careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-directed Care | Experimental | Individuals in the experimental condition will work with a specially trained certified peer specialists (CPS) who will serve as "recovery coaches" to develop an individualized recovery plan that describes their goals and desires. They will then work with the team to select both the behavioral health treatment and rehabilitation services, and the non-behavioral health materials and resources they believe are necessary to achieve their goals. Receives: Behavioral: self-directed care |
| Treatment as usual | No intervention | Participants in the control condition will receive services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline TU Community Participation Questionnaire to follow up at 12 months and 24 months post-baseline
Used to gather information about the frequency of participation in multiple domains (e.g., employment, education, spirituality, leisure/recreation, attendance at self-help groups, etc.) in the last 30 days, whether or not they did the activity enough, not enough, or too much in addition to their level of satisfaction with their level of participation in the activity.
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Recovery Assessment Scale to follow up at 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Quality of Life to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Hopkins Symptom Checklist to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Empowerment Scale to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Coping Mastery Questionnaire to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Perceived Competence for Recovery Questionnaire to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Perceived Autonomy Support: The Mental Health Questionnaire to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Elements of a Recovery Facilitating Systems Assessment Questionnaire - Adult Version to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Revised Camberwell Assessment of Need Questionnaire to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Treatment Self-Regulation Questionnaire to 12 months and 24 months post-baseline
Measured: Baseline, 12 months- and 24 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University Collaborative on Community Inclusion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Salzer, Temple University Collaborative on Community Inclusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520024
- Sponsor's protocol ID
- 13304
- Status last verified
- Aug 2015
- First submitted
- 1 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living
- ClinicalTrials.gov ID
- NCT02520024
- Acronym / sponsor ID
- 13304
- Conditions
- Major Depression, Bipolar Disorder, Schizophrenia
- Keywords
- self-directed care, serious mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Temple University Collaborative on Community InclusionUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment. The study examined outcomes associated with the implementation of a novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-directed Care | Experimental | Behavioral: self-directed careIndividuals in the experimental condition will work with a specially trained certified peer specialists (CPS) who will serve as "recovery coaches" to develop an individualized recovery plan that describes their goals and desires. They will then work with the team to select both the behavioral health treatment and rehabilitation services, and the non-behavioral health materials and resources they believe are necessary to achieve their goals. |
| Treatment as usual | No intervention | –Participants in the control condition will receive services as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 18-65 who are currently receiving Medicaid-reimbursed services in Delaware County, Pennsylvania for either a schizophrenia-spectrum, major depression, or bipolar disorder;
- Individuals with a cost profile within the 60-90% band of all Magellan-administered Medicaid recipients in the county (estimated service costs between $10,048 and $22,324); 3) No more than two inpatient hospitalizations of 10 days per stay, over a 2 year period prior to the study;
- 4) No hospitalization within 6 months of the study; 5) Ability to understand self-directed care requirement and express interest in working with a "recovery coach."
Key exclusion criteria (3 listed)
- do not speak English;
- have a legal guardian;
- are unable to give informed consent
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 |
|---|---|---|
| self-directed care | Behavioural | Self-directed Care |
Primary outcome
Change from Baseline TU Community Participation Questionnaire to follow up at 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Used to gather information about the frequency of participation in multiple domains (e.g., employment, education, spirituality, leisure/recreation, attendance at self-help groups, etc.) in the last 30 days, whether or not they did the activity enough, not enough, or too much in addition to their level of satisfaction with their level of participation in the activity.
Change from Baseline Recovery Assessment Scale to follow up at 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Quality of Life to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Hopkins Symptom Checklist to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Empowerment Scale to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Coping Mastery Questionnaire to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Perceived Competence for Recovery Questionnaire to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Perceived Autonomy Support: The Mental Health Questionnaire to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Elements of a Recovery Facilitating Systems Assessment Questionnaire - Adult Version to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Revised Camberwell Assessment of Need Questionnaire to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Change from Baseline Treatment Self-Regulation Questionnaire to 12 months and 24 months post-baseline
Time frame: Baseline, 12 months- and 24 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing self-directed care in people with Major Depression and Bipolar Disorder, run by Temple University Collaborative on Community Inclusion.
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 3 inclusion and 3 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 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline TU Community Participation Questionnaire to follow up at 12 months and 24 months post-baseline (time frame: Baseline, 12 months- and 24 months post-baseline). The study lists 11 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 11 Aug 2015.