Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Harvard University
Commonwealth Research Center, Massachusetts
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00434980
First received: February 12, 2007
Last updated: January 21, 2016
Last verified: January 2016
  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:

  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.

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Behavioral: Family-Directed Cognitive Adaptation Program
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Social Adaptive Functions Scale (P) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Multnomah Community Ability Scale (P) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (P) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale, Positive and Negative syndrome Scale, Scale for the Assessment of Negative symptoms [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interpersonal Affectivity Scale (P, F); Knowledge Questionnaire (P, F), Independent Living Skills Survey (P, F),Ind Living Self Care Checklist (P, F [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Cognition in Schizophrenia (P, F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Patient Rejection Scale (F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Modified Family Resources Interview (F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Family Self-Efficacy Scale (F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Caregiving Gains and Benefits/ Gratifications Module (F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Beck Depression and Anxiety Inventories (F) [ Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (P, F) [ Time Frame: end of treatment, and 3 months after end of treatment, 6 months after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2005
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Participant and family take part in FCA treatment program.
Behavioral: Family-Directed Cognitive Adaptation Program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or older,
  2. fluent in English.
  3. 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).
  4. Lives with at least one family member or long-term partner (> 1 year).
  5. 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:

  1. Diagnosis of dementia, neurodegenerative disease, pervasive developmental disorder, or other neurological disorder such as a serious traumatic brain injury that produces significant cognitive impairments.
  2. Individuals diagnosed with psychotic disorders due to a general medical condition or substance-induced psychotic disorders.
  3. Substance abuse (to substances other than nicotine) in past three months or dependence in the past year.
  4. Patients who, in the investigator's clinical opinion and based on evaluation, pose a current homicide or suicide risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434980

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Massachusetts Mental Health Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
Harvard University
Commonwealth Research Center, Massachusetts
Investigators
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

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00434980     History of Changes
Other Study ID Numbers: 2005P-000383 
Study First Received: February 12, 2007
Last Updated: January 21, 2016
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:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2016