Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI)

Schizophrenia Clinical Trial

Official title:

Individually Based Psychosocial Rehabilitation for Older People With SMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817154
• Other study ID #: K23MH080021
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

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