Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia

Completed · Not applicable

Conditions studied: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

In brief

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.

Key facts

Study ID

NCT00434980

Run by

Beth Israel Deaconess Medical Center

People needed

11

Starts

2005-02-01

Expected to finish

2015-02-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older,
• fluent in English.
• Primary Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) Axis I diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder. Diagnoses will be confirmed by review of client's records and prior structured research interview and/or the Structured Clinical Interview for the DSM-IV (SCID).
• Lives with at least one family member or long-term partner (> 1 year).
• Voluntary informed consent for participation in the study by the participant (or by the participant's legally designated guardian) and the participant's family member.

You may not qualify if…

• Diagnosis of dementia, neurodegenerative disease, pervasive developmental disorder, or other neurological disorder such as a serious traumatic brain injury that produces significant cognitive impairments.
• Individuals diagnosed with psychotic disorders due to a general medical condition or substance-induced psychotic disorders.
• Substance abuse (to substances other than nicotine) in past three months or dependence in the past year.
• Patients who, in the investigator's clinical opinion and based on evaluation, pose a current homicide or suicide risk.

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States
• Massachusetts Mental Health Center — Jamaica Plain, Massachusetts, United States

Full record on ClinicalTrials.gov

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