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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00817154
Other study ID # K23MH080021
Secondary ID
Status Completed
Phase Phase 1
First received January 5, 2009
Last updated May 5, 2014
Start date November 2009
Est. completion date December 2013

Study information

Verified date May 2014
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 choose not to access a group program.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

1. Age 50+;

2. ability to provide voluntary informed consent or assent, with formal consent by a legal guardian;

3. Axis I Disorder of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression;

4. Functional impairment based on New Hampshire state eligibility criteria for services to people with SMI;

5. Enrollment in treatment for at least three months.

Exclusion Criteria:

1. residence in a nursing home or assisted living facility;

2. Terminal illness expected to result in death within one year or less;

3. Diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental Status Evaluation (MMSE) score <24;

4. Current active substance abuse or dependence;

5. Past Participation in HOPES-G

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

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.

Locations

Country Name City State
United States Riverbend Community Mental Health Center Concord New Hampshire
United States Community Council of Nashua Nashua New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 9 months and 12 months, 15 months No
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