- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817154
Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI)
May 5, 2014 updated by: Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Concord, New Hampshire, United States, 03301
- Riverbend Community Mental Health Center
-
Nashua, New Hampshire, United States, 03060
- Community Council of Nashua
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hopes-I
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
baseline, 9 months and 12 months, 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sarah I Pratt, Ph.D., Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Estimate)
May 7, 2014
Last Update Submitted That Met QC Criteria
May 5, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH080021 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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