Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia
Recruitment status was Recruiting
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Purpose
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:
- 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.
- 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.
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Behavioral: Family-Directed Cognitive Adaptation Program |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of the Feasibility of a Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia |
- All of the following are measured at baseline, post-intervention,
- and 3 and 6-month follow up
- Social Adaptive Functions Scale (P)
- Multnomah Community Ability Scale (P)
- Global Assessment of Functioning (P)
- F= Family measure P= Patient measure
- All of the following are measured at baseline, post-intervention,
- and 3 and 6-month follow up
- BPRS, PANSS (P)
- SANS (P)
- Interpersonal Affectivity Scale (P, F)
- Knowledge Questionnaire (P, F)
- Independent Living Skills Survey (P, F)
- Ind Living Self Care Checklist (P, F)
- Frontal Lobe Personality Scale (P, F)
- Clinical Global Impression of Cognition in Schizophrenia (P, F)
- Patient Rejection Scale (F)
- Modified Family Resources Interview (F)
- Modified Schizophrenia Knowledge Scale (F)
- Family Self-Efficacy Scale (F)
- Caregiving Gains and Benefits/ Gratifications Module (F)
- Beck Depression and Anxiety Inventories (F)
- This measure is completed post-intervention only:
- Client Satisfaction Questionnaire (P, F)
- F= Family measure P= Patient measure
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or older,
- fluent in English.
- Primary 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Michelle S. Friedman-Yakoobian, Ph.D. | 617-626-9357 | mfriedmanyakoobian@partners.org |
| United States, Massachusetts | |
| Freedom Trail Clinic | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D. | |
| Massachusetts Mental Health Center | Recruiting |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D. | |
| Study Chair: | Larry J. Seidman, Ph.D. | Beth Israel Deaconess Medical Center |
| Principal Investigator: | Michelle S. Friedman-Yakoobian, Ph.D. | Beth Israel Deaconess Medical Center / Massachusetts General Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00434980 History of Changes |
| Other Study ID Numbers: | 2005P-000383 |
| Study First Received: | February 12, 2007 |
| Last Updated: | February 13, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Cognitive adaption Schizophrenia Cognitive rehabilitation |
Family treatment Cognitive deficits Serious mental illness |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013