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NCT00434980 · ClinicalTrials.gov registry record · NA
Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia
A NA study of Schizophrenia and Schizoaffective Disorder, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT00434980 is a NA study of Schizophrenia and Schizoaffective Disorder that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 11 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00434980, a NA study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a pilot study evaluating the feasibility of a new family-based intervention for schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the devastating effects of neurocognitive deficits on everyday functioning (Family-Directed Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to devastating functional impairments and caregiver burden, as clients rely on caregivers for help with basic living needs, such as personal hygiene, time management, social skills, and progress towards vocational and educational goals. Specifically, we will 1) Develop a manualized, family treatment program designed to improve adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility study to evaluate the acceptability and feasibility of this intervention, and to collect preliminary outcome data. This will lay the foundation for a controlled trial of the efficacy of the intervention. We expect that: 1. The FCA intervention will be well-received and well-tolerated by clients and families, as demonstrated by a high level of interest in the program, a low rate of attrition, and a high rate of participant satisfaction. 2. Client participants in the FCA intervention will show improvements in adaptive, independent-living skills (e.g., personal hygiene and self-care, medication management, time management, social skills, and responsibility for health maintenance) that will be maintained three and six months following completion of the intervention. 3. Family members participating in the FCA program will show reduced burden of care and time spent caregiving, greater satisfaction in their relationship with the client, improved self-efficacy in the caregiver role, and reduced psychological distress (e.g., depression, anxiety, and hopelessness) at the completion of the program and at three and six-month follow-up interviews.
Conditions Studied
Interventions
- BEHAVIORAL Family-Directed Cognitive Adaptation Program
Study Locations (2)
Massachusetts
- Freedom Trail Clinic - Boston
- Massachusetts Mental Health Center - Jamaica Plain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2005-02 |
| Est. Completion | 2015-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00434980
The ClinicalTrials.gov registry entry for NCT00434980 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Family-Directed Cognitive Adaptation Program is the first listed.
NCT00434980 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00434980 about?
NCT00434980 is a clinical study titled "Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia". This is a pilot study evaluating the feasibility of a new family-based intervention for schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the devastating effects of neurocognitive deficits on everyday functioning (Family-Directed Cognitive Adaptation, FCA). Cogni...
What is the current status of trial NCT00434980?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2005-02. Estimated completion is 2015-02.
What conditions does trial NCT00434980 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder.
What interventions are being tested in trial NCT00434980?
The interventions under investigation include: Family-Directed Cognitive Adaptation Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT00434980?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00434980 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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