NCT00434980

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

10 years

First QC Date

February 12, 2007

Last Update Submit

March 10, 2017

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Keywords

Cognitive adaptionSchizophreniaCognitive rehabilitationFamily treatmentCognitive deficitsSerious mental illness

Outcome Measures

Primary Outcomes (4)

  • Social Adaptive Functions Scale (P)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Multnomah Community Ability Scale (P)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Global Assessment of Functioning (P)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Brief Psychiatric Rating Scale, Positive and Negative syndrome Scale, Scale for the Assessment of Negative symptoms

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

Secondary Outcomes (8)

  • Interpersonal Affectivity Scale (P, F); Knowledge Questionnaire (P, F), Independent Living Skills Survey (P, F),Ind Living Self Care Checklist (P, F

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Clinical Global Impression of Cognition in Schizophrenia (P, F)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Patient Rejection Scale (F)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Modified Family Resources Interview (F)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • Family Self-Efficacy Scale (F)

    Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

  • +3 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Participant and family take part in FCA treatment program.

Behavioral: Family-Directed Cognitive Adaptation Program

Interventions

Family-Directed Cognitive Adaptation ProgramBEHAVIORAL
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Massachusetts Mental Health Center

Jamaica Plain, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersCognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Study Officials

  • Larry J. Seidman, Ph.D.

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

  • Michelle S. Friedman-Yakoobian, Ph.D.

    Beth Israel Deaconess Medical Center / Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Psychology in the Department of Psychiatry

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

February 1, 2005

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(2)