Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI) - Full Text View

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center National Institutes of Health (NIH)
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00817154

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression	Behavioral: HOPES-I	Phase I

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Individually Based Psychosocial Rehabilitation for Older People With SMI

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Mental Health Rehabilitation Schizophrenia

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2009
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual Care (UC): No Intervention Participants will receive usual care from their treatment team. They will also participate in research study interviews.
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.	Behavioral: 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.

Arms

Assigned Interventions

Usual Care (UC): No Intervention

Participants will receive usual care from their treatment team. They will also participate in research study interviews.

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.

Behavioral: 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 NH 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817154

Contacts

Contact: Sarah I. Pratt, Ph.D.	603-271-8345	sarah.i.pratt@dartmouth.edu
Contact: Amanda M. Hapenny, BA	603-271-8344	amanda.m.hapenny@dartmouth.edu

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sarah I Pratt, Ph.D.

Dartmouth-Hitchcock Medical Center

More Information

No publications provided

Responsible Party:	Dartmouth-Hitchcock Medical Center ( Sarah Pratt, PhD )
Study ID Numbers:	K23MH080021
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817154 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Older persons with SMI

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders

Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Disease
Bipolar Disorder
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Schizophrenia

Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 02, 2009