SchizophreniaPhase 1NCT00817154
Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI)
A Phase 1 study testing HOPES-I in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
The major goal of this project is to adapt an existing group-based psychosocial program to enhance community functioning in older people with serious mental illness (SMI). The focus of the adaptation is designing and evaluating an individually based rehabilitative program for older people with SMI who either cannot or… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- HOPES-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Dec 2013
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50+;
- ability to provide voluntary informed consent or assent, with formal consent by a legal guardian;
- Axis I Disorder of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression;
- Functional impairment based on New Hampshire state eligibility criteria for services to people with SMI;
- Enrollment in treatment for at least three months.
Who cannot join
- residence in a nursing home or assisted living facility;
- Terminal illness expected to result in death within one year or less;
- Diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental Status Evaluation (MMSE) score <24;
- Current active substance abuse or dependence;
- Past Participation in HOPES-G
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Riverbend Community Mental Health Center
Concord, New Hampshire, 03301
Community Council of Nashua
Nashua, New Hampshire, 03060
About this study
Official title: Individually Based Psychosocial Rehabilitation for Older People With SMI
The major goal of this project is to adapt an existing group-based psychosocial program to enhance community functioning in older people with serious mental illness (SMI). The focus of the adaptation is designing and evaluating an individually based rehabilitative program for older people with SMI who either cannot or choose not to access a group program.
- Being tested
- HOPES-I
- Keywords
- Older persons with SMI
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPES-IBehavioural
The program progresses in three steps. First, participants receive a 10-week Basic Skills for Community Living course covering essential skills from each of the five modules to ensure that all participants establish basic competency in a core set of skills. Second, clinicians assess participants' functioning to identify skill areas that warrant additional improvement and engage participants in a shared decision making process to select skill areas to pursue in greater depth. Third, clinicians have weekly 60 minute sessions with participants in community settings for 7 months to provide training and to facilitate and support acquisition of core skills and rehabilitation goals.
| Study group | Role | What they receive |
|---|---|---|
| Hopes-I | Experimental | The program progresses in three steps. First, participants receive a 10-week Basic Skills for Community Living course covering essential skills from each of the five modules to ensure that all participants establish basic competency in a core set of skills. Second, clinicians assess participants' functioning to identify skill areas that warrant additional improvement and engage participants in a shared decision making process to select skill areas to pursue in greater depth. Third, clinicians have weekly 60 minute sessions with participants in community settings for 7 months to provide training and to facilitate and support acquisition of core skills and rehabilitation goals. Receives: Behavioral: HOPES-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop an individually based psychosocial rehabilitation program for older adults with SMI. The program will be specified in treatment manuals and will match relevant skills training modules to the functional needs and preferences of consumers.
Measured: baseline, 9 months and 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sarah I Pratt, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817154
- Sponsor's protocol ID
- K23MH080021
- Status last verified
- May 2014
- First submitted
- 5 Jan 2009
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Based Psychosocial Rehabilitation for Older People With SMI
- ClinicalTrials.gov ID
- NCT00817154
- Acronym / sponsor ID
- K23MH080021
- Keywords
- Older persons with SMI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jan 2009 (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.
The major goal of this project is to adapt an existing group-based psychosocial program to enhance community functioning in older people with serious mental illness (SMI). The focus of the adaptation is designing and evaluating an individually based rehabilitative program for older people with SMI who either cannot or choose not to access a group program.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hopes-I | Experimental | Behavioral: HOPES-IThe program progresses in three steps. First, participants receive a 10-week Basic Skills for Community Living course covering essential skills from each of the five modules to ensure that all participants establish basic competency in a core set of skills. Second, clinicians assess participants' functioning to identify skill areas that warrant additional improvement and engage participants in a shared decision making process to select skill areas to pursue in greater depth. Third, clinicians have weekly 60 minute sessions with participants in community settings for 7 months to provide training and to facilitate and support acquisition of core skills and rehabilitation goals. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50+;
- ability to provide voluntary informed consent or assent, with formal consent by a legal guardian;
- Axis I Disorder of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression;
- Functional impairment based on New Hampshire state eligibility criteria for services to people with SMI;
- Enrollment in treatment for at least three months.
Key exclusion criteria (5 listed)
- residence in a nursing home or assisted living facility;
- Terminal illness expected to result in death within one year or less;
- Diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental Status Evaluation (MMSE) score <24;
- Current active substance abuse or dependence;
- Past Participation in HOPES-G
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 |
|---|---|---|
| HOPES-IThe program progresses in three steps. First, participants receive a 10-week Basic Skills for Community Living course covering essential skills from each of the five modules to ensure that all participants establish basic competency in a core set of skills. Second, clinicians assess participants' functioning to identify skill areas that warrant additional improvement and engage participants in a shared decision making process to select skill areas to pursue in greater depth. Third, clinicians have weekly 60 minute sessions with participants in community settings for 7 months to provide training and to facilitate and support acquisition of core skills and rehabilitation goals. | Behavioural | Hopes-I |
Primary outcome
To develop an individually based psychosocial rehabilitation program for older adults with SMI. The program will be specified in treatment manuals and will match relevant skills training modules to the functional needs and preferences of consumers.
Time frame: baseline, 9 months and 12 months, 15 months
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 7 May 2014.
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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.
Sarah I Pratt, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HOPES-I in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites 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 5 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To develop an individually based psychosocial rehabilitation program for older adults with SMI. The program will be specified in treatment manuals and will match relevant skills training modules to the functional needs and preferences of consumers. (time frame: baseline, 9 months and 12 months, 15 months). 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 7 May 2014.