NCT00817154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

4.1 years

First QC Date

January 5, 2009

Last Update Submit

May 5, 2014

Conditions

Keywords

Older persons with SMI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

HOPES-IBEHAVIORAL

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.

Hopes-I

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riverbend Community Mental Health Center

Concord, New Hampshire, 03301, United States

Location

Community Council of Nashua

Nashua, New Hampshire, 03060, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Study Officials

  • Sarah I Pratt, Ph.D.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations